By GARDINER HARRIS
WASHINGTON, June 26 — As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.
How this money may be influencing psychiatrists and other doctors has become one of the most contentious issues in health care. For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved.
Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.
Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.
The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.
“For the fourth year in a row, our analysis shows that there is a great deal of money being spent in our small state on marketing pharmaceutical products,” said William H. Sorrell, the Vermont attorney general.
Endocrinologists received the second largest amount, according to the Vermont analysis, earning an average of $33,730. Since the state identified the specialties of only the top 100 earners, these averages represent the money earned by only some of the state’s specialists. There were 11 psychiatrists and 5 endocrinologists in that top group of 100.
Still, a similar pattern was evident in a Minnesota database that was the subject of a series of articles in The New York Times this year. As in Vermont, psychiatrists earned on aggregate the most in Minnesota, with payments ranging from $51 to $689,000. The Times found that psychiatrists who took the most money from makers of antipsychotic drugs tended to prescribe the drugs to children the most often.
These and other stories have helped to fuel a growing interest among state and federal officials to document and restrict payments to doctors from drug makers. At a gathering last month at Columbia Law School in New York, state attorneys general from across the country discussed ways to get similar data for their states.
And today, the Senate Special Committee on Aging, which is led by Senator Herb Kohl, Democrat of Wisconsin, will hold the first of a series of hearings on the issue, which could lead to legislative proposals to restrict and require disclosure of payments and gifts to doctors from drug companies nationwide.
Several lawmakers on Capitol Hill have expressed interest in such legislation, including Senator Charles E. Grassley, Republican of Iowa. “A federal law requiring public disclosure of payments to doctors could be very effective if it was carefully monitored and consistently applied,” Mr. Grassley said.
Efforts to require disclosure of payments to doctors began almost by happenstance in 1993, when The Minnesota Legislature passed a law that restricts drug companies from giving doctors gifts valued at more than $100 in any given year. The legislation also required companies to report and make public any consulting fees paid to doctors.
Lee Greenfield, a former state representative in Minnesota and one of the law’s authors, said it passed with little fanfare or debate after legislators heard stories about doctors accepting gifts of great value from drug makers.
“Why do we want them bribing doctors to use what may not be the best or most cost-effective drug for the patient purely to get some hand-held TV, we all asked,” Mr. Greenfield said.
Still, compliance with the law has been spotty. Some companies never responded to the board’s requests for disclosures. Others did so fitfully. A few sent letters saying they did not collect that information and thus could not provide it.
Minnesota officials never cracked down. Such reports were put in file drawers and largely forgotten until this past year, said Cody Wiberg, executive director of the Minnesota Board of Pharmacy. Mr. Wiberg said he planned this year to pursue companies that fail to report.
Besides Vermont and Maine, more than a dozen other states have or are now considering similar legislation, said Sharon Anglin Treat, executive director of the National Legislative Association on Prescription Drug Prices.
Officials in Maine and Vermont said they would try to compare reports of payments to doctors with Medicaid records to explore how marketing practices might influence prescribing by doctors in ways that increased costs to taxpayers.
“What we want to be able to do is overlay the prescribing information that we have with the drug detailing information,” said Jude Walsh, special assistant to the governor of Maine, John E. Baldacci. “If we see that doctors in a certain southern county in the state are prescribing a lot of a drug and getting a lot of detailing for that drug, that could lead to some record reviews to see what’s happening.”
Thursday, June 28, 2007
Study Finds Many Injuries to Surgeons Go Unreported
By LAWRENCE K. ALTMAN
Nearly all surgeons accidentally stick themselves with needles and sharp instruments while in training. But most fail to report the injuries, risking their health and that of their families and patients to the threat of diseases including AIDS, hepatitis and many other blood-borne illnesses, according to a survey being published today.
Their being rushed was the chief reason the surgical residents cited for the injuries, which were mostly self-inflicted. Among the reasons they cited for not reporting the potentially fatal injuries was that doing so would take too much time, could jeopardize career opportunities and might cause a loss of face among peers.
In addition, there was a false belief that getting even timely medical attention would not prevent infection. In fact, immediate treatment with antiviral drugs can prevent infection among those stuck with needles while caring for patients with the viruses that cause AIDS and hepatitis B. Immediate treatment can also prevent chronic infection among those infected with hepatitis C virus.
The survey, being published in The New England Journal of Medicine, was conducted by researchers at Georgetown University and Johns Hopkins University, and involved 699 doctors who in 2003 were surgical residents at 17 medical centers in the United States.
The findings are further evidence of a need to strengthen protection measures recommended by experts like Dr. Julie L. Gerberding, now director of the Centers for Disease Control and Prevention, from the many studies they began conducting in the 1980s, soon after the discovery of AIDS.
Surgeons have been urged to provide more specific instruction to trainees about safe techniques and what to do if injured. Other infection-reducing measures directed at surgeons include: wearing two sets of surgical gloves; substituting electric scalpels, clips and glues for sharp instruments; improving techniques for handing instruments from one health care professional to another; using postoperative checklists; and increasing the use of nurse practitioners and physician assistants to reduce surgical workloads. For those who experience needle stick injuries, additional steps include use of internal hot lines to summon response teams.
“Every operating room and training program should insist on the use of these techniques,” said Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University, who was not involved with the new study.
In addition, infection control experts have urged doctors to apply the same precautions in caring for all patients rather than make judgments about the risks of infection in a particular case. Studies have shown that doctors underestimate the likelihood that one of their patients may be silently infected with a blood-borne virus.
But “this concept of standard precautions has not yet been deeply rooted in many trainees,” Dr. Schaffner said.
The survey’s senior author, Dr. Martin A. Makary, a surgeon at Johns Hopkins, said in an interview that surgeons had made “little progress in the last 20 years” in preventing needle stick injuries. And hospitals, he said, “are not doing what they should to care for their own providers, their families and patients.”
Dr. Makary said he had undertaken the study in part because two friends of his, both surgeons, had experienced serious emotional trauma after being stuck by needles while treating patients who had documented cases of AIDS and hepatitis C.
Such an experience among surgeons in training “traumatizes their psyche on top of the stress of residency,” Dr. Makary said.
“They do not know whether to tell their significant other,” he said, “and if they do report it to hospital officials, they worry about being stigmatized.”
An estimated 800,000 needle stick injuries occur each year among health care workers in this country. Of the participants in Dr. Makary’s confidential survey, 99 percent had experienced at least one needle stick injury by the end of the fifth and last year of surgical training (the average was eight such injuries). Of these, 51 percent failed to report their injuries to an employee health service as some hospitals require.
Of those who did report, 53 percent had been stuck while working on a patient at high risk for common, potentially fatal infections. The strongest predictor for reporting was someone else’s knowledge about the injury.
Nearly all surgeons accidentally stick themselves with needles and sharp instruments while in training. But most fail to report the injuries, risking their health and that of their families and patients to the threat of diseases including AIDS, hepatitis and many other blood-borne illnesses, according to a survey being published today.
Their being rushed was the chief reason the surgical residents cited for the injuries, which were mostly self-inflicted. Among the reasons they cited for not reporting the potentially fatal injuries was that doing so would take too much time, could jeopardize career opportunities and might cause a loss of face among peers.
In addition, there was a false belief that getting even timely medical attention would not prevent infection. In fact, immediate treatment with antiviral drugs can prevent infection among those stuck with needles while caring for patients with the viruses that cause AIDS and hepatitis B. Immediate treatment can also prevent chronic infection among those infected with hepatitis C virus.
The survey, being published in The New England Journal of Medicine, was conducted by researchers at Georgetown University and Johns Hopkins University, and involved 699 doctors who in 2003 were surgical residents at 17 medical centers in the United States.
The findings are further evidence of a need to strengthen protection measures recommended by experts like Dr. Julie L. Gerberding, now director of the Centers for Disease Control and Prevention, from the many studies they began conducting in the 1980s, soon after the discovery of AIDS.
Surgeons have been urged to provide more specific instruction to trainees about safe techniques and what to do if injured. Other infection-reducing measures directed at surgeons include: wearing two sets of surgical gloves; substituting electric scalpels, clips and glues for sharp instruments; improving techniques for handing instruments from one health care professional to another; using postoperative checklists; and increasing the use of nurse practitioners and physician assistants to reduce surgical workloads. For those who experience needle stick injuries, additional steps include use of internal hot lines to summon response teams.
“Every operating room and training program should insist on the use of these techniques,” said Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University, who was not involved with the new study.
In addition, infection control experts have urged doctors to apply the same precautions in caring for all patients rather than make judgments about the risks of infection in a particular case. Studies have shown that doctors underestimate the likelihood that one of their patients may be silently infected with a blood-borne virus.
But “this concept of standard precautions has not yet been deeply rooted in many trainees,” Dr. Schaffner said.
The survey’s senior author, Dr. Martin A. Makary, a surgeon at Johns Hopkins, said in an interview that surgeons had made “little progress in the last 20 years” in preventing needle stick injuries. And hospitals, he said, “are not doing what they should to care for their own providers, their families and patients.”
Dr. Makary said he had undertaken the study in part because two friends of his, both surgeons, had experienced serious emotional trauma after being stuck by needles while treating patients who had documented cases of AIDS and hepatitis C.
Such an experience among surgeons in training “traumatizes their psyche on top of the stress of residency,” Dr. Makary said.
“They do not know whether to tell their significant other,” he said, “and if they do report it to hospital officials, they worry about being stigmatized.”
An estimated 800,000 needle stick injuries occur each year among health care workers in this country. Of the participants in Dr. Makary’s confidential survey, 99 percent had experienced at least one needle stick injury by the end of the fifth and last year of surgical training (the average was eight such injuries). Of these, 51 percent failed to report their injuries to an employee health service as some hospitals require.
Of those who did report, 53 percent had been stuck while working on a patient at high risk for common, potentially fatal infections. The strongest predictor for reporting was someone else’s knowledge about the injury.
Diabetes Prevalence Has Risen Nearly 5% Annually Since 1990
The prevalence of diabetes has risen almost 5% per year since 1990, according to a CDC analysis of NHANES data.
The study, presented at the American Diabetes Association's annual meeting, found that the age-adjusted prevalence of diabetes increased 4.6% per year from 1990 to 2005. Notably, obesity began to increase at a more rapid rate in 1986.
The study, presented at the American Diabetes Association's annual meeting, found that the age-adjusted prevalence of diabetes increased 4.6% per year from 1990 to 2005. Notably, obesity began to increase at a more rapid rate in 1986.
Computerized Ordering Cuts Medication Errors
WEDNESDAY, June 27 (HealthDay News) -- U.S. hospitals that switched from using doctors' handwritten prescriptions to computerized drug ordering systems had a 66 percent drop in medication errors, say the authors of a review that looked at the results of 12 studies.
The findings are published online in the journal Health Services Research.
Almost 25 percent of U.S. hospital patients experience medication errors, such as receiving an incorrect dosage, the wrong drug, medication at the wrong time, or no medication at all. Each year, medication errors injure or kill more than 500,000 U.S. hospital patients, according to background information in the review.
Illegible handwriting on prescriptions and transcription mistakes cause as many as 61 percent of medication errors, the experts said.
"These medication errors are very painful for doctors, as well as the patients. Nobody wants to make a mistake," lead author Tatyana Shamliyan, a research associate at the University of Minnesota School of Public Health, said in a prepared statement.
She and her colleagues found that hospitals with the highest rate of medication errors -- more than 12 percent -- showed the most improvement when they switched to computerized drug ordering systems.
They also found that while the use of computerized systems reduced medication errors overall, there was no decrease in one type of error -- prescribing the wrong drug.
Currently, only about 9 percent of U.S. hospitals have computerized prescription systems, which can take 12 to 36 months to implement.
More information
The Institute for Safe Medication Practices explains how to protect yourself against medication errors.
The findings are published online in the journal Health Services Research.
Almost 25 percent of U.S. hospital patients experience medication errors, such as receiving an incorrect dosage, the wrong drug, medication at the wrong time, or no medication at all. Each year, medication errors injure or kill more than 500,000 U.S. hospital patients, according to background information in the review.
Illegible handwriting on prescriptions and transcription mistakes cause as many as 61 percent of medication errors, the experts said.
"These medication errors are very painful for doctors, as well as the patients. Nobody wants to make a mistake," lead author Tatyana Shamliyan, a research associate at the University of Minnesota School of Public Health, said in a prepared statement.
She and her colleagues found that hospitals with the highest rate of medication errors -- more than 12 percent -- showed the most improvement when they switched to computerized drug ordering systems.
They also found that while the use of computerized systems reduced medication errors overall, there was no decrease in one type of error -- prescribing the wrong drug.
Currently, only about 9 percent of U.S. hospitals have computerized prescription systems, which can take 12 to 36 months to implement.
More information
The Institute for Safe Medication Practices explains how to protect yourself against medication errors.
Blood type influences lung cancer mortality
An analysis of data from a Danish study shows that inflammation factors are stronger predictors of lung cancer mortality in individuals with blood type O than those with other blood types.
The inflammatory response is thought to play a key role in the development of lung cancer and there is evidence that this response is influenced by a person's ABO type, according to the report in the European Respiratory Journal.
The most important blood types are in the ABO group, which can be typed for all humans and many other primates. There are four principal types: A, B, AB, and O. The combination of these four components determines an individual's type.
To investigate the impact of ABO type on lung cancer risk factors, Dr. P. Suadicani and colleagues at Bispebjerg University Hospital assessed the long-term outcomes of 3346 men enrolled in the Copenhagen Male Study. The average age was 63 years and the subjects were followed for 16 years.
During follow-up, 170 subjects died from lung cancer, including 84 (5.9 percent) with type O, 70 (4.9 percent) with type A and 16 (3.2 percent) with type B/AB.
In men with type O blood, cumulative tobacco use, high salt intake, long-term occupational dust exposure, high fat intake, alcohol consumption, and older age were all risk factors for lung cancer mortality. High salt levels in the diet, long-term occupational dust exposure, and heavy alcohol use (more than 10 wine drinks per week) each increased the risk of lung cancer death by more than twofold.
By contrast, in men with blood type A, only total tobacco use and increasing age were linked to lung cancer death. With type B/AB, increasing age and possibly long-term occupational dust exposure were risk factors for lung cancer mortality.
These findings suggest that the ABO type strongly affects whether various lifestyle factors impact the risk of lung cancer mortality, the authors conclude.
SOURCE: European Respiratory Journal, June 27, 2007.
The inflammatory response is thought to play a key role in the development of lung cancer and there is evidence that this response is influenced by a person's ABO type, according to the report in the European Respiratory Journal.
The most important blood types are in the ABO group, which can be typed for all humans and many other primates. There are four principal types: A, B, AB, and O. The combination of these four components determines an individual's type.
To investigate the impact of ABO type on lung cancer risk factors, Dr. P. Suadicani and colleagues at Bispebjerg University Hospital assessed the long-term outcomes of 3346 men enrolled in the Copenhagen Male Study. The average age was 63 years and the subjects were followed for 16 years.
During follow-up, 170 subjects died from lung cancer, including 84 (5.9 percent) with type O, 70 (4.9 percent) with type A and 16 (3.2 percent) with type B/AB.
In men with type O blood, cumulative tobacco use, high salt intake, long-term occupational dust exposure, high fat intake, alcohol consumption, and older age were all risk factors for lung cancer mortality. High salt levels in the diet, long-term occupational dust exposure, and heavy alcohol use (more than 10 wine drinks per week) each increased the risk of lung cancer death by more than twofold.
By contrast, in men with blood type A, only total tobacco use and increasing age were linked to lung cancer death. With type B/AB, increasing age and possibly long-term occupational dust exposure were risk factors for lung cancer mortality.
These findings suggest that the ABO type strongly affects whether various lifestyle factors impact the risk of lung cancer mortality, the authors conclude.
SOURCE: European Respiratory Journal, June 27, 2007.
Sharpening Your Wits Could Outwit Alzheimer's
WEDNESDAY, June 27 (HealthDay News) -- Doing plenty of mentally-stimulating activities -- such as playing chess, reading a newspaper, or attending a play -- in old age helps reduce the risk of Alzheimer's disease, according to a study of more than 700 elderly Americans.
The Chicago residents, who averaged 80 years of age at the start of the study, underwent annual cognitive testing for up to five years. During the study, 90 people developed Alzheimer's disease, and 102 died.
However, the Rush University Medical Center researchers found that those who were "cognitively active" were 2.6 times less likely than those who got minimal mental stimulation to develop Alzheimer's disease.
The study, published June 27 in the journal Neurology, also found that frequent mental stimulation was associated with a reduced risk of mild cognitive impairment -- a transitional stage between normal aging and dementia -- and less rapid decline in cognitive function.
The researchers said their findings may help in the development of strategies to prevent or delay Alzheimer's disease.
More information
The U.S. National Institute on Aging discusses whether Alzheimer's disease can be prevented.
The Chicago residents, who averaged 80 years of age at the start of the study, underwent annual cognitive testing for up to five years. During the study, 90 people developed Alzheimer's disease, and 102 died.
However, the Rush University Medical Center researchers found that those who were "cognitively active" were 2.6 times less likely than those who got minimal mental stimulation to develop Alzheimer's disease.
The study, published June 27 in the journal Neurology, also found that frequent mental stimulation was associated with a reduced risk of mild cognitive impairment -- a transitional stage between normal aging and dementia -- and less rapid decline in cognitive function.
The researchers said their findings may help in the development of strategies to prevent or delay Alzheimer's disease.
More information
The U.S. National Institute on Aging discusses whether Alzheimer's disease can be prevented.
Wednesday, June 27, 2007
ADA Multimedia:AVANDIA PROS AND CONS
CHICAGO, June 26 -- In the month since the New England Journal of Medicine published a meta-analysis that linked use of rosiglitazone (Avandia) to an increased risk of myocardial infarction, controversy surrounding the use of this popular diabetes drug has continued unabated. Earlier this month a Congressional hearing investigated the FDA's handling of rosiglitazone and several medical journals have weighed in with editorials on the controversy. The American Diabetes Association addressed the issue at a special symposium.
SEE LINK BELOW :
http://www.medpagetoday.com/MeetingCoverage/ADAMeeting/tb1/6022
SEE LINK BELOW :
http://www.medpagetoday.com/MeetingCoverage/ADAMeeting/tb1/6022
AANP: Treatment for IBS Includes Education, Reassurance, and Medication
INDIANAPOLIS, June 26 -- Although the recent withdrawal of tegaserod from the market has left a hole in the options available to treat irritable bowel syndrome (IBS), there are still many available.
So said Julia Pallentino, M.S.N, J.D., ARNP-BC, of the Medical Group of North Florida in Tallahassee, at the American Academy of Nurse Practitioners meeting here.
Education, reassurance, and medication are the key elements in treating irritable bowel syndrome (IBS), she told attendees.
"Reassurance is reinforcing the fact that IBS is a real condition and not just in the patient's head," she said. "And it's telling patients that there are treatments available to alleviate the discomfort they feel."
The second component, education, includes clearing up any confusion patients have about their actual diagnosis. Many do not know that IBS, spastic colon, and functional bowel are all names for the same condition.
Teaching should reinforce that discomfort is caused by psychological alterations and that there is a link between symptoms and stress.
Medications traditionally treat the symptoms. The drugs that will be useful in treating a particular patient will depend on the symptoms the patient has.
"Final treatment options will largely be arrived at by trial and error," said Pallentino. "We try something and see if it helps, if not try something else."
Drug regimens for abdominal pain would include antispasmodic medications such as dicyclomine or Donnatal. They work to prevent spasms in the muscles of the gut by relaxing them, and also reduce the amount of stomach acid produced.
Tricyclic antidepressants in low dose may help reduce pain. Pallentino said she usually suggests amitriptyline 50 mg at bedtime. However, tricyclics should not be used in most cases when the patient is constipated; their anticholinergic properties slow the gut down.
When bloating and distention is the concern, antispasmodics are often useful. Over the counter antiflatulents such as Beano or Gas-X may help. Pallentino also said she's found that capsules of activated charcoal sold over-the-counter have been useful.
Digestive enzymes can help relieve this symptom, too. Pancreatic enzymes are available by prescription or through health food stores.
In some cases, antibiotics may lessen the bloating and distention caused by bacterial overgrowth. Among the antibiotics typically suggested for IBS are tetracycline and neomycin.
Constipation in IBS can respond to increased intake of fiber and fluids, along with exercise, Pallentino said. Laxatives may also be used.
Although not specifically labeled for IBS, lubiprostone is indicated for idiopathic constipation. It has chloride channel action that draws fluid into the bowel and causes a motility effect.
"The dosage is 24 micrograms twice daily with food," she said. "I tell my patients to take the pills when they take the first bite of food so they don't take it too early. This helps lessen the chance of nausea. "
Probiotics, dietary supplements that contain potentially beneficial bacteria or yeast "appear to be helpful in treating constipation," said Pallentino. "Most of the research shows some improvement and that is encouraging."
Fiber and antispasmodics also have a role in treating diarrhea associated with IBS. Antidiarrheal drugs, including over-counter medications such as loperamide, work well for many patients.
"Although off-label, the bile sequestrant colesevelam has worked in patients with explosive diarrhea," said Pallentino. "One or two tablets a day at breakfast and dinner to start and adjust up or down according to symptoms."
Alosetron is a medication labeled for treatment of severe, diarrhea-predominant IBS if all other treatments fail. Because of the risk of ulcerative colitis, the drug is available through limited use-only approved physicians. There is a detailed patient warning and signed consent form that must be used. Careful control and frequent monitoring is required.
"Although alosetron is technically available, the paperwork involved and the few physicians that are approved to prescribe it, make the drug unavailable to most patients," said Pallentino.
The only medication with an indication for IBS constipation, tegaserod was withdrawn from the market at the request of the Food and Drug Administration in March. It was associated with a higher risk for serious cardiovascular adverse events when compared with placebo. Whether it will become available again and under what conditions is still unknown, said Pallentino.
"IBS is a chronic condition that severely affects the quality of life," said Pallentino. "It is very amenable to treatment currently and the future holds hope that there may soon be other agents to address the effects of IBS."
Pallentino disclosed financial support from Novartis Pharmaceuticals, Sucampo Pharmaceuticals, Takeda Pharmaceuticals North America, AstraZeneca, Proctor & Gamble, and Roche.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "The ABCs & Ds of IBS"
So said Julia Pallentino, M.S.N, J.D., ARNP-BC, of the Medical Group of North Florida in Tallahassee, at the American Academy of Nurse Practitioners meeting here.
Education, reassurance, and medication are the key elements in treating irritable bowel syndrome (IBS), she told attendees.
"Reassurance is reinforcing the fact that IBS is a real condition and not just in the patient's head," she said. "And it's telling patients that there are treatments available to alleviate the discomfort they feel."
The second component, education, includes clearing up any confusion patients have about their actual diagnosis. Many do not know that IBS, spastic colon, and functional bowel are all names for the same condition.
Teaching should reinforce that discomfort is caused by psychological alterations and that there is a link between symptoms and stress.
Medications traditionally treat the symptoms. The drugs that will be useful in treating a particular patient will depend on the symptoms the patient has.
"Final treatment options will largely be arrived at by trial and error," said Pallentino. "We try something and see if it helps, if not try something else."
Drug regimens for abdominal pain would include antispasmodic medications such as dicyclomine or Donnatal. They work to prevent spasms in the muscles of the gut by relaxing them, and also reduce the amount of stomach acid produced.
Tricyclic antidepressants in low dose may help reduce pain. Pallentino said she usually suggests amitriptyline 50 mg at bedtime. However, tricyclics should not be used in most cases when the patient is constipated; their anticholinergic properties slow the gut down.
When bloating and distention is the concern, antispasmodics are often useful. Over the counter antiflatulents such as Beano or Gas-X may help. Pallentino also said she's found that capsules of activated charcoal sold over-the-counter have been useful.
Digestive enzymes can help relieve this symptom, too. Pancreatic enzymes are available by prescription or through health food stores.
In some cases, antibiotics may lessen the bloating and distention caused by bacterial overgrowth. Among the antibiotics typically suggested for IBS are tetracycline and neomycin.
Constipation in IBS can respond to increased intake of fiber and fluids, along with exercise, Pallentino said. Laxatives may also be used.
Although not specifically labeled for IBS, lubiprostone is indicated for idiopathic constipation. It has chloride channel action that draws fluid into the bowel and causes a motility effect.
"The dosage is 24 micrograms twice daily with food," she said. "I tell my patients to take the pills when they take the first bite of food so they don't take it too early. This helps lessen the chance of nausea. "
Probiotics, dietary supplements that contain potentially beneficial bacteria or yeast "appear to be helpful in treating constipation," said Pallentino. "Most of the research shows some improvement and that is encouraging."
Fiber and antispasmodics also have a role in treating diarrhea associated with IBS. Antidiarrheal drugs, including over-counter medications such as loperamide, work well for many patients.
"Although off-label, the bile sequestrant colesevelam has worked in patients with explosive diarrhea," said Pallentino. "One or two tablets a day at breakfast and dinner to start and adjust up or down according to symptoms."
Alosetron is a medication labeled for treatment of severe, diarrhea-predominant IBS if all other treatments fail. Because of the risk of ulcerative colitis, the drug is available through limited use-only approved physicians. There is a detailed patient warning and signed consent form that must be used. Careful control and frequent monitoring is required.
"Although alosetron is technically available, the paperwork involved and the few physicians that are approved to prescribe it, make the drug unavailable to most patients," said Pallentino.
The only medication with an indication for IBS constipation, tegaserod was withdrawn from the market at the request of the Food and Drug Administration in March. It was associated with a higher risk for serious cardiovascular adverse events when compared with placebo. Whether it will become available again and under what conditions is still unknown, said Pallentino.
"IBS is a chronic condition that severely affects the quality of life," said Pallentino. "It is very amenable to treatment currently and the future holds hope that there may soon be other agents to address the effects of IBS."
Pallentino disclosed financial support from Novartis Pharmaceuticals, Sucampo Pharmaceuticals, Takeda Pharmaceuticals North America, AstraZeneca, Proctor & Gamble, and Roche.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "The ABCs & Ds of IBS"
Two Adjuvant Treatments for Breast Cancer Earn Their Keep
TORONTO, June 26 -- Two well-accepted adjuvant therapies for early breast cancer proved cost-effective for improving survival, according to a pair of studies.
Both exemestane (Aromasin) and trastuzumab (Herceptin) have been proven effective in adjuvant breast cancer therapy, and the drugs are included in professional treatment guidelines.
But given their cost, one set of researchers in Canada and another in the U.S. evaluated the cost-effectiveness of the drugs, and reported their findings online in Cancer, with publication in the Aug. 1 issue of the journal.
Each study, one for each drug, found a low projected lifetime cost under $30,000 per life-year gained, adjusted for quality of life.
In the Canadian study of postmenopausal women with estrogen-receptor-positive breast cancer, switching to adjuvant exemestane, an aromatase inhibitor, after two or three years of tamoxifen (Nolvadex) extended disease-free survival at a minimal cost of under $3,000 per patient per year over 7.5 years, Nicole Mittmann, M.Sc., Ph.D., of the University of Toronto, and colleagues found.
Their analysis used a hypothetical cohort of postmenopausal women from the recent Intergroup Exemestane Study (IES), which found a survival benefit for switching to exemestane.
Disease progression and hazard ratios for recurrence and survival were determined from IES datasets, the Surveillance, Epidemiology, and End Results program of the National Cancer Institute, and from published literature.
Cost-effectiveness, from a government-payer perspective, was measured not only in life years gained but was adjusted for gain in quality of life. The combination was expressed as quality-adjusted life years gained.
Five years after completing adjuvant therapy (a total of 7.5 years) a tamoxifen-exemestane adjuvant protocol improved absolute disease-free survival by 2.6% (80.9% versus 78% for tamoxifen alone).
Compared with continued tamoxifen, sequential therapy with tamoxifen and exemestane increased the total discounted medical costs in Canadian dollars by $2,889 per patient over 7.5 years.
Cost savings in the exemestane group for reduced cancer recurrence were $1,680 per person and for other cancers, $221 per person.
The incremental cost-effectiveness ratio for exemestane was $28,119 per life year gained.
Calculated as the quality-adjusted life year gained, the incremental cost-utility ratio was $24,185.
This was well below the estimated threshold of $50,000 Canadian per quality-adjusted life year gained, the researchers reported.
A limitation of the study, the researchers noted, is that the analysis was based on data from a clinical trial, which may not reflect real-world practice.
This study reinforces the recent recommendation in Canada to fund the sequential use of tamoxifen and exemestane as a standard of care for postmenopausal women with ER-positive breast cancer or breast cancer of unknown ER status, Dr. Mittmann and her colleagues concluded.
In the second study of breast cancer patients positive for human epidermal growth factor receptor 2 (HER2-positive), adding trastuzumab proved cost-effective over an estimated lifetime, Louis P. Garrison Jr., Ph.D., of the University of Washington in Seattle, and colleagues reported.
From a payer-perspective, trastuzumab, a monoclonal antibody that targets HER2, was estimated to be cost-effective at a projected low lifetime cost of $26,417 per quality-adjusted life year gained, the researchers said.
Long-term survival and outcome data based on a joint analysis of two major clinical trials were projected from a Markov model with four health states (treatment, disease-free, distant recurrence, and death).
Heathcare resource costs were based on 2006 Medicare reimbursement rates and other published data.
The researchers estimated the cost for a 50-year old woman on the basis of trial results through four years and estimates of long-term recurrence and death derived from a meta-analysis of the trials.
From six years onward, rates of recurrence and death were assumed to be the same in both the trastuzumab and standard chemotherapy-only arms.
Over a lifetime, the projected cost of trastuzumab per quality-adjusted life year gained was a low $26,417 (range, $9,104 to $69,340 under sensitivity analysis), the researchers reported.
The incremental lifetime cost was $44,923, while the projected life expectancy was three years longer for patients who received trastuzumab (19.4 years versus 16.4 years).
Over 20 years, the projected cost of adding trastuzumab to chemotherapy was $34,201 per quality-adjusted life year gained.
Key drivers of cost effectiveness were price of the drug and the probability of metastasis. The cost-effectiveness result was robust to sensitivity analysis, the researchers reported.
The low $26,416 lifetime projection was driven by substantial absolute advantages in clinical outcomes observed with trastuzumab in the joint analysis of the two major trials. These included a 16-percentage-point improvement in freedom from distant recurrence and a 4.8-point improvement in overall survival at four years, the researchers said.
Trastuzumab for adjuvant treatment of early stage breast cancer was projected to be cost-effective over a lifetime horizon, achieving a cost-effectiveness ratio below that of many widely accepted oncology treatments, the researchers concluded.
Dr. Mittmann and co-author Nancy A. Risebrough, B.A., reported receiving unrestricted funding from Pfizer Canada, Inc., for the economic evaluation of exemestane. The study was supported by a grant from Pfizer Inc. The researchers also thanked two Pfizer employees for their detailed review of this article, which was prepared with the assistance of BioMedCom Consultants Inc. of Montreal.
Primary source: CancerSource reference: Risebrough NA, et al "Cost-effectiveness of Switching to Exemestane Versus Continued Tamoxifen as Adjuvant Therapy for Postmenopausal Women With Primary Breast Cancer" Cancer 2007; DOI: 10.1002/cncr.22824. Additional source: CancerSource reference: Garrison Jr. LP. Et al "Cost-effectiveness Analysis of Trastuzumab in the Adjuvant Setting for Treatment of HER-2-Positive Breast Cancer" Cancer 2007; DOI: 10.1002/cncr.22806.
Both exemestane (Aromasin) and trastuzumab (Herceptin) have been proven effective in adjuvant breast cancer therapy, and the drugs are included in professional treatment guidelines.
But given their cost, one set of researchers in Canada and another in the U.S. evaluated the cost-effectiveness of the drugs, and reported their findings online in Cancer, with publication in the Aug. 1 issue of the journal.
Each study, one for each drug, found a low projected lifetime cost under $30,000 per life-year gained, adjusted for quality of life.
In the Canadian study of postmenopausal women with estrogen-receptor-positive breast cancer, switching to adjuvant exemestane, an aromatase inhibitor, after two or three years of tamoxifen (Nolvadex) extended disease-free survival at a minimal cost of under $3,000 per patient per year over 7.5 years, Nicole Mittmann, M.Sc., Ph.D., of the University of Toronto, and colleagues found.
Their analysis used a hypothetical cohort of postmenopausal women from the recent Intergroup Exemestane Study (IES), which found a survival benefit for switching to exemestane.
Disease progression and hazard ratios for recurrence and survival were determined from IES datasets, the Surveillance, Epidemiology, and End Results program of the National Cancer Institute, and from published literature.
Cost-effectiveness, from a government-payer perspective, was measured not only in life years gained but was adjusted for gain in quality of life. The combination was expressed as quality-adjusted life years gained.
Five years after completing adjuvant therapy (a total of 7.5 years) a tamoxifen-exemestane adjuvant protocol improved absolute disease-free survival by 2.6% (80.9% versus 78% for tamoxifen alone).
Compared with continued tamoxifen, sequential therapy with tamoxifen and exemestane increased the total discounted medical costs in Canadian dollars by $2,889 per patient over 7.5 years.
Cost savings in the exemestane group for reduced cancer recurrence were $1,680 per person and for other cancers, $221 per person.
The incremental cost-effectiveness ratio for exemestane was $28,119 per life year gained.
Calculated as the quality-adjusted life year gained, the incremental cost-utility ratio was $24,185.
This was well below the estimated threshold of $50,000 Canadian per quality-adjusted life year gained, the researchers reported.
A limitation of the study, the researchers noted, is that the analysis was based on data from a clinical trial, which may not reflect real-world practice.
This study reinforces the recent recommendation in Canada to fund the sequential use of tamoxifen and exemestane as a standard of care for postmenopausal women with ER-positive breast cancer or breast cancer of unknown ER status, Dr. Mittmann and her colleagues concluded.
In the second study of breast cancer patients positive for human epidermal growth factor receptor 2 (HER2-positive), adding trastuzumab proved cost-effective over an estimated lifetime, Louis P. Garrison Jr., Ph.D., of the University of Washington in Seattle, and colleagues reported.
From a payer-perspective, trastuzumab, a monoclonal antibody that targets HER2, was estimated to be cost-effective at a projected low lifetime cost of $26,417 per quality-adjusted life year gained, the researchers said.
Long-term survival and outcome data based on a joint analysis of two major clinical trials were projected from a Markov model with four health states (treatment, disease-free, distant recurrence, and death).
Heathcare resource costs were based on 2006 Medicare reimbursement rates and other published data.
The researchers estimated the cost for a 50-year old woman on the basis of trial results through four years and estimates of long-term recurrence and death derived from a meta-analysis of the trials.
From six years onward, rates of recurrence and death were assumed to be the same in both the trastuzumab and standard chemotherapy-only arms.
Over a lifetime, the projected cost of trastuzumab per quality-adjusted life year gained was a low $26,417 (range, $9,104 to $69,340 under sensitivity analysis), the researchers reported.
The incremental lifetime cost was $44,923, while the projected life expectancy was three years longer for patients who received trastuzumab (19.4 years versus 16.4 years).
Over 20 years, the projected cost of adding trastuzumab to chemotherapy was $34,201 per quality-adjusted life year gained.
Key drivers of cost effectiveness were price of the drug and the probability of metastasis. The cost-effectiveness result was robust to sensitivity analysis, the researchers reported.
The low $26,416 lifetime projection was driven by substantial absolute advantages in clinical outcomes observed with trastuzumab in the joint analysis of the two major trials. These included a 16-percentage-point improvement in freedom from distant recurrence and a 4.8-point improvement in overall survival at four years, the researchers said.
Trastuzumab for adjuvant treatment of early stage breast cancer was projected to be cost-effective over a lifetime horizon, achieving a cost-effectiveness ratio below that of many widely accepted oncology treatments, the researchers concluded.
Dr. Mittmann and co-author Nancy A. Risebrough, B.A., reported receiving unrestricted funding from Pfizer Canada, Inc., for the economic evaluation of exemestane. The study was supported by a grant from Pfizer Inc. The researchers also thanked two Pfizer employees for their detailed review of this article, which was prepared with the assistance of BioMedCom Consultants Inc. of Montreal.
Primary source: CancerSource reference: Risebrough NA, et al "Cost-effectiveness of Switching to Exemestane Versus Continued Tamoxifen as Adjuvant Therapy for Postmenopausal Women With Primary Breast Cancer" Cancer 2007; DOI: 10.1002/cncr.22824. Additional source: CancerSource reference: Garrison Jr. LP. Et al "Cost-effectiveness Analysis of Trastuzumab in the Adjuvant Setting for Treatment of HER-2-Positive Breast Cancer" Cancer 2007; DOI: 10.1002/cncr.22806.
ADA: Metabolic Syndrome Helps Predict Mortality Risk
CHICAGO, June 26 -- Metabolic syndrome and its components helped predict mortality for diabetic and non-diabetic patients alike, independently of Framingham cardiovascular risk, researchers found.
In a large study of patients at a preventive cardiology clinic, metabolic syndrome was associated with 53% higher mortality risk than seen among patients who did not have diabetes or metabolic syndrome, said Krupa B. Doshi, M.D., of the Cleveland Clinic, and colleagues.
Fasting plasma glucose and waist circumference-components of metabolic syndrome-were significant predictors of mortality risk in an analysis that adjusted for Framingham score and other factors (P<0.05 for both), they reported at the American Diabetes Association meeting here.
Their findings suggest that the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines on metabolic syndrome do have clinical relevance, Dr. Doshi said.
"It does help identify the group of patients that need aggressive risk management," she said.
The researchers retrospectively reviewed outcomes for patients who were referred to their cardiology clinic for primary or secondary prevention and seen from 1995 to 2006.
Among the patients, 1,189 had diabetes, 1,241 had metabolic syndrome (met more than three of the NCEP ATP III criteria) but not diabetes, and 3,023 had neither.
Overall there were 360 deaths.
Mortality rates were highest for patients with diabetes (hazard ratio 2.97, 95% confidence interval 2.33 to 3.79, P<0.001), followed by those with metabolic syndrome (HR 1.53, 95% CI 1.17 to 2.01, P=0.002) compared with the group with neither condition.
Other outcome measures showed the same pattern. Occurrence of cardiovascular events was significantly higher among patients with diabetes than among those with metabolic syndrome and among metabolic syndrome patients than among those who had neither condition, respectively, for coronary artery bypass grafts (P<0.01 and P=0.017), chronic heart failure (P<0.001 and P=0.001), myocardial infarction (P=0.001 and P<0.001), and peripheral arterial disease (P<0.001 and P=NS).
In a multivariate analysis adjusted for Framingham score, age, gender, total cholesterol, and fibrinogen, the findings for patients with metabolic syndrome were:
Fasting plasma glucose was a significant contributor to mortality risk (concordance index 0.779, P<0.05).
Waist circumference was a significant contributor to mortality risk (concordance index 0.766, P<0.05).
Blood pressure, high-density lipoprotein cholesterol, triglycerides, and body mass index were not significant contributors to mortality risk by themselves.
The researchers concluded, "Both NCEP metabolic syndrome and Framingham scores are very informative." They "suggest coordinated use to predict mortality in a high-risk cohort."
The study was supported in part by the National Institutes of Health.Primary source: American Diabetes Association meetingSource reference: Doshi KB, et al "Mortality and Cardiovascular Events Increased in Non-diabetic Subjects with Metabolic Syndrome; Fasting Glucose a Strong Predictor of Increased Mortality: A PRECIS Database Cohort Study" ADA meeting 2007; Abstract 975-P.
In a large study of patients at a preventive cardiology clinic, metabolic syndrome was associated with 53% higher mortality risk than seen among patients who did not have diabetes or metabolic syndrome, said Krupa B. Doshi, M.D., of the Cleveland Clinic, and colleagues.
Fasting plasma glucose and waist circumference-components of metabolic syndrome-were significant predictors of mortality risk in an analysis that adjusted for Framingham score and other factors (P<0.05 for both), they reported at the American Diabetes Association meeting here.
Their findings suggest that the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines on metabolic syndrome do have clinical relevance, Dr. Doshi said.
"It does help identify the group of patients that need aggressive risk management," she said.
The researchers retrospectively reviewed outcomes for patients who were referred to their cardiology clinic for primary or secondary prevention and seen from 1995 to 2006.
Among the patients, 1,189 had diabetes, 1,241 had metabolic syndrome (met more than three of the NCEP ATP III criteria) but not diabetes, and 3,023 had neither.
Overall there were 360 deaths.
Mortality rates were highest for patients with diabetes (hazard ratio 2.97, 95% confidence interval 2.33 to 3.79, P<0.001), followed by those with metabolic syndrome (HR 1.53, 95% CI 1.17 to 2.01, P=0.002) compared with the group with neither condition.
Other outcome measures showed the same pattern. Occurrence of cardiovascular events was significantly higher among patients with diabetes than among those with metabolic syndrome and among metabolic syndrome patients than among those who had neither condition, respectively, for coronary artery bypass grafts (P<0.01 and P=0.017), chronic heart failure (P<0.001 and P=0.001), myocardial infarction (P=0.001 and P<0.001), and peripheral arterial disease (P<0.001 and P=NS).
In a multivariate analysis adjusted for Framingham score, age, gender, total cholesterol, and fibrinogen, the findings for patients with metabolic syndrome were:
Fasting plasma glucose was a significant contributor to mortality risk (concordance index 0.779, P<0.05).
Waist circumference was a significant contributor to mortality risk (concordance index 0.766, P<0.05).
Blood pressure, high-density lipoprotein cholesterol, triglycerides, and body mass index were not significant contributors to mortality risk by themselves.
The researchers concluded, "Both NCEP metabolic syndrome and Framingham scores are very informative." They "suggest coordinated use to predict mortality in a high-risk cohort."
The study was supported in part by the National Institutes of Health.Primary source: American Diabetes Association meetingSource reference: Doshi KB, et al "Mortality and Cardiovascular Events Increased in Non-diabetic Subjects with Metabolic Syndrome; Fasting Glucose a Strong Predictor of Increased Mortality: A PRECIS Database Cohort Study" ADA meeting 2007; Abstract 975-P.
AANP: Polypharmacy Prevention Is Responsibility of All
INDIANAPOLIS, June 26 -- Polypharmacy represents a potential problem for patients of any age, but it can be managed safely through diligence on the part of caregivers and patients.
If it isn't monitored, said Thomas W. Barkley, Jr., D.S.N., APRN-RC, coordinator of the Acute Care Nurse Practitioner Program at California State University in Los Angeles, the result is likely to be overmedication, money wasted on drugs that may not be needed, drug interactions that can lead to over- or under-dosing, and even death.
Dr. Barkley told attendees at the American Academy of Nurse Practitioners meeting here that prevention of polypharmacy -- when a patient takes three or more drugs -- is the responsibility of all involved in healthcare, including the patient.
Polypharmacy sometimes appropriate, said Barkley, such as when a patient needs multi-drug treatment to handle comorbid conditions."
One contributing factor to polypharmacy is self-medication by the patient, said Dr. Barkley. Surveys show that 73% of Americans would rather treat themselves at home than see a doctor and 96% are confident about their ability to make their own healthcare decisions.
This decreases the ability of healthcare providers to properly monitor potentially dangerous interactions.
Patients' ability to start their own regimens without input from a healthcare provider is increasing as more medications make the switch to over-the-counter (OTC) status. There are more than 700 products available OTC today that were prescription-only less than 30 years ago, said Dr. Barkley.
Elderly patients are certainly at high risk for polypharmacy -- seniors consume 34% of all prescription drugs, 33% of all over the counter drugs and 6.5 million use 1 of 33 inappropriate prescription drugs. But, the possibility should not be discounted in other patients. Patients with co-morbidities, with multiple healthcare providers, and those who use fill prescriptions at more than one pharmacy are at increased risk.
"I spend 2 minutes at the end of every interaction going back over the patient's medications," said Barkley. "I ask about everything they have ever taken to include those medications they may take sporadically, those given by other providers, and OTC or herbal preparations. 'Ever' being the keyword here."
He suggests encouraging patients and their caregivers to:
Closely monitor the patient for any physiological or psychological changes after a change in dosage or medication.
Keep a list of all medications along with dosage, schedules, and dates of first use.
Never add any herbs, supplements (including vitamins), or OTC medications without first asking their healthcare provider.
Use only one pharmacy.
Always know the reason why each medication is needed.
Never use medications prescribed for others.
Responsibilities for those with prescriptive authority include such interventions as prompting the patient to report on what they are using, discontinuing unnecessary medications, closely monitoring the patient following changes is dose or medications, using single dose regimens and using one drug to treat multiple problems when possible, and avoiding the use of as-needed medications.
"Consider all new medications to be therapeutic trials," said Dr. Barkley. "Tell the patient that this isn't necessarily forever, and that you will evaluate together how well it is working in a few weeks."
"Overall polypharmacy is widespread and not limited to elderly patients," he said. "The risks can be substantially diminished by close monitoring and that is the collective responsibility of all involved."
Dr. Barkley reported no financial support.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "Polypharmacy: Pills, Potions, Problems, and Prevention"
If it isn't monitored, said Thomas W. Barkley, Jr., D.S.N., APRN-RC, coordinator of the Acute Care Nurse Practitioner Program at California State University in Los Angeles, the result is likely to be overmedication, money wasted on drugs that may not be needed, drug interactions that can lead to over- or under-dosing, and even death.
Dr. Barkley told attendees at the American Academy of Nurse Practitioners meeting here that prevention of polypharmacy -- when a patient takes three or more drugs -- is the responsibility of all involved in healthcare, including the patient.
Polypharmacy sometimes appropriate, said Barkley, such as when a patient needs multi-drug treatment to handle comorbid conditions."
One contributing factor to polypharmacy is self-medication by the patient, said Dr. Barkley. Surveys show that 73% of Americans would rather treat themselves at home than see a doctor and 96% are confident about their ability to make their own healthcare decisions.
This decreases the ability of healthcare providers to properly monitor potentially dangerous interactions.
Patients' ability to start their own regimens without input from a healthcare provider is increasing as more medications make the switch to over-the-counter (OTC) status. There are more than 700 products available OTC today that were prescription-only less than 30 years ago, said Dr. Barkley.
Elderly patients are certainly at high risk for polypharmacy -- seniors consume 34% of all prescription drugs, 33% of all over the counter drugs and 6.5 million use 1 of 33 inappropriate prescription drugs. But, the possibility should not be discounted in other patients. Patients with co-morbidities, with multiple healthcare providers, and those who use fill prescriptions at more than one pharmacy are at increased risk.
"I spend 2 minutes at the end of every interaction going back over the patient's medications," said Barkley. "I ask about everything they have ever taken to include those medications they may take sporadically, those given by other providers, and OTC or herbal preparations. 'Ever' being the keyword here."
He suggests encouraging patients and their caregivers to:
Closely monitor the patient for any physiological or psychological changes after a change in dosage or medication.
Keep a list of all medications along with dosage, schedules, and dates of first use.
Never add any herbs, supplements (including vitamins), or OTC medications without first asking their healthcare provider.
Use only one pharmacy.
Always know the reason why each medication is needed.
Never use medications prescribed for others.
Responsibilities for those with prescriptive authority include such interventions as prompting the patient to report on what they are using, discontinuing unnecessary medications, closely monitoring the patient following changes is dose or medications, using single dose regimens and using one drug to treat multiple problems when possible, and avoiding the use of as-needed medications.
"Consider all new medications to be therapeutic trials," said Dr. Barkley. "Tell the patient that this isn't necessarily forever, and that you will evaluate together how well it is working in a few weeks."
"Overall polypharmacy is widespread and not limited to elderly patients," he said. "The risks can be substantially diminished by close monitoring and that is the collective responsibility of all involved."
Dr. Barkley reported no financial support.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "Polypharmacy: Pills, Potions, Problems, and Prevention"
Portion-Control Dishware Helps Obese Diabetics Lose Weight
TUESDAY, June 26 (HealthDay News) -- Using a plate and cereal bowl that indicate proper portion sizes helped obese patients with diabetes lose weight and decrease their use of glucose-controlling medications, says a Canadian study.
The plates -- divided into painted-line sections for carbohydrates, proteins, vegetables, cheese and sauce -- held enough for an 800-calorie meal for men and a 650-calorie meal for women. The bowl allowed for a 200-calorie serving of cereal and milk.
Over six months, about half of 122 patients (average age 56) used the portion-control plates and bowls, while the rest of the patients received usual care consisting of dietary assessments and teaching by dietitians.
The patients who used the portion-control plates and bowls lost an average of 1.8 percent of their body weight, compared to an average of 0.1 percent among those who received usual care.
The University of Calgary researchers also found that 16.9 percent of the patients who used the portion-control plates and bowls, which were donated by a U.K. company called The Diet Plate, lost at least 5 percent of their body weight, compared with 4.6 percent of patients who received usual care.
"This is important, as a 5 percent weight loss has been shown to be clinically significant in terms of decreasing morbidity and mortality associated with obesity-linked disorders such as cancer and (heart attack)," the study authors wrote.
The use of diabetes medications decreased by 26.2 percent among patients using the plates and bowls, compared with 10.8 percent among those who received usual care.
The portion-control plates and bowls offer a simple, inexpensive method of weight control that shows promise in helping obese people with diabetes, the study authors concluded.
The findings were published in the June 25 issue of the journal Archives of Internal Medicine.
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about eating and diabetes.
The plates -- divided into painted-line sections for carbohydrates, proteins, vegetables, cheese and sauce -- held enough for an 800-calorie meal for men and a 650-calorie meal for women. The bowl allowed for a 200-calorie serving of cereal and milk.
Over six months, about half of 122 patients (average age 56) used the portion-control plates and bowls, while the rest of the patients received usual care consisting of dietary assessments and teaching by dietitians.
The patients who used the portion-control plates and bowls lost an average of 1.8 percent of their body weight, compared to an average of 0.1 percent among those who received usual care.
The University of Calgary researchers also found that 16.9 percent of the patients who used the portion-control plates and bowls, which were donated by a U.K. company called The Diet Plate, lost at least 5 percent of their body weight, compared with 4.6 percent of patients who received usual care.
"This is important, as a 5 percent weight loss has been shown to be clinically significant in terms of decreasing morbidity and mortality associated with obesity-linked disorders such as cancer and (heart attack)," the study authors wrote.
The use of diabetes medications decreased by 26.2 percent among patients using the plates and bowls, compared with 10.8 percent among those who received usual care.
The portion-control plates and bowls offer a simple, inexpensive method of weight control that shows promise in helping obese people with diabetes, the study authors concluded.
The findings were published in the June 25 issue of the journal Archives of Internal Medicine.
More information
The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about eating and diabetes.
More vitamin D can put more pep in seniors' steps
By Charnicia HugginsTue Jun 26, 12:20 PM ET
Declining physical performance among some Dutch seniors may not be a simple consequence of aging, it may actually be due to a vitamin D deficiency, results of a new study suggest.
"Physicians and the general public should be made more aware of the high prevalence of vitamin D deficiency and insufficiency, and more effort should be concentrated on the early detection and treatment of people with suboptimal levels of vitamin D," study co-author Dr. Paul Lips, of VU University Medical Center in Amsterdam, and his colleagues write.
Previous research has shown that low vitamin D status is not uncommon among seniors, which may be explained by their decreased exposure to sunshine, reduced dietary consumption of vitamin D, and reduced capacity to naturally synthesize the vitamin. This deficiency is known to result in bone loss and fractures, among other bone and muscle-related problems.
The extent to which an individual's vitamin D status can affect his or her physical performance, however, has not been as well explored.
To investigate, Lips and his colleagues analyzed data on 979 seniors, 65 years or older, who were involved in the ongoing Longitudinal Aging Study Amsterdam.
They found that the study participants' vitamin D status was indeed associated with their physical performance, even after the seniors' age, the presence of chronic diseases, extent of alcohol consumption and various other factors were taken into account, they report in the Journal of Clinical Endocrinology & Metabolism.
For example, nearly half (47 percent) of the seniors had low vitamin D levels at the start of the study, and their deficiency was associated with poorer physical performance than their peers. Over the 3-year study, these vitamin D-deficient adults were also twice as likely as their peers to exhibit a decline in physical performance, such as taking longer to rise from a sitting position.
In light of these findings, "public health strategies should be aimed at this group," the researchers conclude.
The findings can also be generalized to other groups of older Dutch Caucasians, as well as to younger people, who may simply be better able to compensate for their vitamin D deficiency and subsequent decline in physical performance.
Vitamin D deficiency is not unique to the Dutch population, however. Dr. Nancy S. Wellman, a spokesperson for the American Society for Nutrition, told Reuters Health that "vitamin D is one of the most common shortfall nutrients in diets of older Americans."
"It is not found naturally in many foods," she explained.
To address this problem, Wellman, a professor and director of the National Resource Center on Nutrition, Physical Activity & Aging, at Florida International University, advises seniors to drink milk or orange juice that is fortified with vitamin D and calcium, since "both are needed for bone health."
SOURCE: Journal of Clinical Endocrinology & Metabolism, online June 2007.
Declining physical performance among some Dutch seniors may not be a simple consequence of aging, it may actually be due to a vitamin D deficiency, results of a new study suggest.
"Physicians and the general public should be made more aware of the high prevalence of vitamin D deficiency and insufficiency, and more effort should be concentrated on the early detection and treatment of people with suboptimal levels of vitamin D," study co-author Dr. Paul Lips, of VU University Medical Center in Amsterdam, and his colleagues write.
Previous research has shown that low vitamin D status is not uncommon among seniors, which may be explained by their decreased exposure to sunshine, reduced dietary consumption of vitamin D, and reduced capacity to naturally synthesize the vitamin. This deficiency is known to result in bone loss and fractures, among other bone and muscle-related problems.
The extent to which an individual's vitamin D status can affect his or her physical performance, however, has not been as well explored.
To investigate, Lips and his colleagues analyzed data on 979 seniors, 65 years or older, who were involved in the ongoing Longitudinal Aging Study Amsterdam.
They found that the study participants' vitamin D status was indeed associated with their physical performance, even after the seniors' age, the presence of chronic diseases, extent of alcohol consumption and various other factors were taken into account, they report in the Journal of Clinical Endocrinology & Metabolism.
For example, nearly half (47 percent) of the seniors had low vitamin D levels at the start of the study, and their deficiency was associated with poorer physical performance than their peers. Over the 3-year study, these vitamin D-deficient adults were also twice as likely as their peers to exhibit a decline in physical performance, such as taking longer to rise from a sitting position.
In light of these findings, "public health strategies should be aimed at this group," the researchers conclude.
The findings can also be generalized to other groups of older Dutch Caucasians, as well as to younger people, who may simply be better able to compensate for their vitamin D deficiency and subsequent decline in physical performance.
Vitamin D deficiency is not unique to the Dutch population, however. Dr. Nancy S. Wellman, a spokesperson for the American Society for Nutrition, told Reuters Health that "vitamin D is one of the most common shortfall nutrients in diets of older Americans."
"It is not found naturally in many foods," she explained.
To address this problem, Wellman, a professor and director of the National Resource Center on Nutrition, Physical Activity & Aging, at Florida International University, advises seniors to drink milk or orange juice that is fortified with vitamin D and calcium, since "both are needed for bone health."
SOURCE: Journal of Clinical Endocrinology & Metabolism, online June 2007.
NYC eateries ready for trans fat switch
By DAVID B. CARUSO, Associated Press WriterTue Jun 26, 6:36 PM ET
No more trans fats with those french fries? No problem. The city's ballyhooed ban on trans fat cooking oils in all New York restaurants — an idea that gave chefs indigestion when first proposed — seems to be going surprisingly smoothly. Across the city, most fast food chains say they've already made the switch days before the July 1 deadline, which is Sunday.
The same cannot be said for a second restaurant rule taking effect then: the posting of calories on fast-food menus. The major chains are defying that regulation and hope a lawsuit will overturn it.
The city doesn't plan to fine anyone for violating either rule until Oct. 1.
Still, the trans fat overhaul is viewed as a major victory by health advocates. Trans fats, found in partially hydrogenated vegetable oils, clog arteries and contribute to heart disease. But they are also cheaper and have a longer shelf life, so industry at first stubbornly resisted dumping them.
That began to change last winter.
Cooking oil companies had already ramped up production of trans-fat alternatives. Restaurant supply companies began stocking kitchens with replacement products.
Big fast food chains that relied heavily on the old oils, from Burger King to Carl's Jr. to Kentucky Fried Chicken, announced they would eliminate the stuff from their fryers nationwide.
Even McDonald's, which had anguished over the potential impact on its french fries, said its phase-in of the new oils in thousands of restaurants has gone unnoticed by customers.
"The transition has been absolutely seamless," said spokesman Walt Riker.
While the city health department hasn't finished tallying results of a recent survey on oil use, there is evidence that smaller restaurants are ready too.
A special help line, set up by the city for chefs trying to reform their kitchens, has been lightly used.
The ease of the switch to zero-trans oils may have been aided by the behind-the-scenes work of seed and oil companies.
David Dzisiak, a cooking oils specialist at Dow AgroSciences, said the company began investing research dollars in zero-trans fat Omega-9 canola and sunflower oils back when the very first studies suggested the oils were unhealthy.
"We started on this 10 years ago," he said. "We now have the capacity to supply over a billion pounds of this oil."
Resistance to the ban still exists, but it may be primarily on philosophical grounds.
Mat Arnfield, the chef at A Salt & Battery, a much-loved Manhattan fish and chips shop, said any cooks still complaining about the change aren't concerned with taste.
The primary difference between the trans-fat oils and their alternatives, he said, is cost. The blend of corn and canola oils he uses in his frying bins now is slightly more expensive than the partially hydrogenated vegetable oils rich in trans fats, but the price difference is small.
"If they are cutting corners that much," he said of restaurants reluctant to switch, "I wouldn't really trust those guys to make me a plate of food anyway."
Restaurants in the city had never kicked too hard over taste considerations, but they had chafed at the idea that anyone should be telling them how to cook.
And there is still some question about whether the ingredients restaurants are using instead of trans fats are just as bad for you. Restaurants can comply by switching to a cooking oil high in saturated fat, which could clog your arteries almost as quickly.
The tougher transition on trans fats could come a year from now, when the city has ordered artificial trans fats out of all products, not just oils and spreads.
Experts say it may be more difficult to find a good replacement for partially hydrogenated vegetable shortenings, which give baked goods like cookies and crackers their characteristic texture.
"That is definitely a more challenging environment," said Bill McCullough, a marketing director for St. Louis-based Bunge Oils.
Alternatives are available, he said, but culinary researchers are still at work on something that will have the taste and texture of butter or lard and the shelf life of a hydrogenated product high in trans fats.
"We realize as an organization that it is just a matter a time before hydrogenation is gone," he said. Bunge has already stopped marketing products containing artificial trans fats, McCullough said.
"We decided it would be like marketing Marlboro Red cigarettes."
No more trans fats with those french fries? No problem. The city's ballyhooed ban on trans fat cooking oils in all New York restaurants — an idea that gave chefs indigestion when first proposed — seems to be going surprisingly smoothly. Across the city, most fast food chains say they've already made the switch days before the July 1 deadline, which is Sunday.
The same cannot be said for a second restaurant rule taking effect then: the posting of calories on fast-food menus. The major chains are defying that regulation and hope a lawsuit will overturn it.
The city doesn't plan to fine anyone for violating either rule until Oct. 1.
Still, the trans fat overhaul is viewed as a major victory by health advocates. Trans fats, found in partially hydrogenated vegetable oils, clog arteries and contribute to heart disease. But they are also cheaper and have a longer shelf life, so industry at first stubbornly resisted dumping them.
That began to change last winter.
Cooking oil companies had already ramped up production of trans-fat alternatives. Restaurant supply companies began stocking kitchens with replacement products.
Big fast food chains that relied heavily on the old oils, from Burger King to Carl's Jr. to Kentucky Fried Chicken, announced they would eliminate the stuff from their fryers nationwide.
Even McDonald's, which had anguished over the potential impact on its french fries, said its phase-in of the new oils in thousands of restaurants has gone unnoticed by customers.
"The transition has been absolutely seamless," said spokesman Walt Riker.
While the city health department hasn't finished tallying results of a recent survey on oil use, there is evidence that smaller restaurants are ready too.
A special help line, set up by the city for chefs trying to reform their kitchens, has been lightly used.
The ease of the switch to zero-trans oils may have been aided by the behind-the-scenes work of seed and oil companies.
David Dzisiak, a cooking oils specialist at Dow AgroSciences, said the company began investing research dollars in zero-trans fat Omega-9 canola and sunflower oils back when the very first studies suggested the oils were unhealthy.
"We started on this 10 years ago," he said. "We now have the capacity to supply over a billion pounds of this oil."
Resistance to the ban still exists, but it may be primarily on philosophical grounds.
Mat Arnfield, the chef at A Salt & Battery, a much-loved Manhattan fish and chips shop, said any cooks still complaining about the change aren't concerned with taste.
The primary difference between the trans-fat oils and their alternatives, he said, is cost. The blend of corn and canola oils he uses in his frying bins now is slightly more expensive than the partially hydrogenated vegetable oils rich in trans fats, but the price difference is small.
"If they are cutting corners that much," he said of restaurants reluctant to switch, "I wouldn't really trust those guys to make me a plate of food anyway."
Restaurants in the city had never kicked too hard over taste considerations, but they had chafed at the idea that anyone should be telling them how to cook.
And there is still some question about whether the ingredients restaurants are using instead of trans fats are just as bad for you. Restaurants can comply by switching to a cooking oil high in saturated fat, which could clog your arteries almost as quickly.
The tougher transition on trans fats could come a year from now, when the city has ordered artificial trans fats out of all products, not just oils and spreads.
Experts say it may be more difficult to find a good replacement for partially hydrogenated vegetable shortenings, which give baked goods like cookies and crackers their characteristic texture.
"That is definitely a more challenging environment," said Bill McCullough, a marketing director for St. Louis-based Bunge Oils.
Alternatives are available, he said, but culinary researchers are still at work on something that will have the taste and texture of butter or lard and the shelf life of a hydrogenated product high in trans fats.
"We realize as an organization that it is just a matter a time before hydrogenation is gone," he said. Bunge has already stopped marketing products containing artificial trans fats, McCullough said.
"We decided it would be like marketing Marlboro Red cigarettes."
Meta-Analysis Finds Echinacea Has Benefits in Cold Prevention and Treatment
A meta-analysis concludes that echinacea supplements decrease the incidence and duration of the common cold.
The analysis, published early online in Lancet Infectious Diseases, suggests that echinacea decreases the odds of developing a cold by 58% and shortens the duration of a cold by 1.4 days. The analysis included 14 studies, which together enrolled about 1400 subjects to study echinacea's effect on incidence and 1600 to study the effect on cold duration.
The authors note that more than 800 U.S. products contain echinacea. They caution that before the plant becomes standard cold treatment, safety studies and large-scale randomized studies are needed, controlling for the dose, the species of echinacea used, the quality of its preparation, the method of cold induction, and the objectivity of the studies' endpoints. Also of note, according to the authors, is that echinacea is an inhibitor of cytochrome P450, and thus may interact with other drugs.
[Editor's note: Although Lancet Infectious Diseases has released this article from embargo, it has not posted the article on its website. Rather than delay coverage further while awaiting that posting, we have provided a link to the Lancet's early-release page, where the article will eventually appear.]
The analysis, published early online in Lancet Infectious Diseases, suggests that echinacea decreases the odds of developing a cold by 58% and shortens the duration of a cold by 1.4 days. The analysis included 14 studies, which together enrolled about 1400 subjects to study echinacea's effect on incidence and 1600 to study the effect on cold duration.
The authors note that more than 800 U.S. products contain echinacea. They caution that before the plant becomes standard cold treatment, safety studies and large-scale randomized studies are needed, controlling for the dose, the species of echinacea used, the quality of its preparation, the method of cold induction, and the objectivity of the studies' endpoints. Also of note, according to the authors, is that echinacea is an inhibitor of cytochrome P450, and thus may interact with other drugs.
[Editor's note: Although Lancet Infectious Diseases has released this article from embargo, it has not posted the article on its website. Rather than delay coverage further while awaiting that posting, we have provided a link to the Lancet's early-release page, where the article will eventually appear.]
Portion Control May Promote Weight Loss in Obese Patients With Type 2 Diabetes Mellitus
June 26, 2007 — Obese patients with type 2 diabetes mellitus who are assigned to a portion control tool as a treatment of obesity have at least a 5% loss in weight compared with those who receive usual care, according to the results of a 6-month randomized controlled trial published in the June 25 issue of the Archives of Internal Medicine.
"Portion size is an important determinant of energy intake," write Sue D. Pedersen, MD, FRCPC, from the University of Calgary in Alberta, Canada, and colleagues. "To our knowledge, no randomized controlled trial has evaluated the efficacy of portion control tools to induce weight loss. In patients with type 2 diabetes mellitus, weight reduction improves glycemic control."
The investigators randomized 130 obese patients with type 2 diabetes mellitus, including 55 patients taking insulin, to daily use for 6 months of a commercially available portion control plate (intervention group) or to usual care with dietary teaching (usual care control group). Follow-up rate was 93.8%.
Compared with the control group, the intervention group had greater mean weight loss (1.8% ± 3.9% vs 0.1% ± 3.0%; P = .006) and a higher proportion of patients who required a decrease in their diabetes medications at 6 months (26.2% vs 10.8%; P = .04).
"Compared with usual care, the portion control tool studied was effective in inducing weight loss," the authors write. "The portion control plate also enabled patients with diabetes mellitus to decrease their hypoglycemic medications without sacrificing glycemic control."
Post hoc analyses suggested that the significant weight loss using this intervention was primarily seen in patients taking insulin.
Study limitations include poor overall compliance with the intervention, patients who frequently eat meals outside of the home being excluded from the study, lack of double blinding, and lack of data regarding quantitative dietary composition changes or caloric expenditure.
"The portion control tool studied in this trial was effective in inducing weight loss in obese persons with type 2 DM [diabetes mellitus] comparable to that seen in investigations of weight loss pharmacotherapy," the authors conclude. "This simple inexpensive tool also enabled obese patients with DM to decrease their hypoglycemic medication requirements. This intervention holds promise for use in overweight populations with and without DM."
The Stewart Diabetes Education Fund sponsored this study. The Diet Plate donated the portion control tools used in this study. The authors have disclosed no relevant financial relationships.
Arch Intern Med. 2007;167:1277-1283.
"Portion size is an important determinant of energy intake," write Sue D. Pedersen, MD, FRCPC, from the University of Calgary in Alberta, Canada, and colleagues. "To our knowledge, no randomized controlled trial has evaluated the efficacy of portion control tools to induce weight loss. In patients with type 2 diabetes mellitus, weight reduction improves glycemic control."
The investigators randomized 130 obese patients with type 2 diabetes mellitus, including 55 patients taking insulin, to daily use for 6 months of a commercially available portion control plate (intervention group) or to usual care with dietary teaching (usual care control group). Follow-up rate was 93.8%.
Compared with the control group, the intervention group had greater mean weight loss (1.8% ± 3.9% vs 0.1% ± 3.0%; P = .006) and a higher proportion of patients who required a decrease in their diabetes medications at 6 months (26.2% vs 10.8%; P = .04).
"Compared with usual care, the portion control tool studied was effective in inducing weight loss," the authors write. "The portion control plate also enabled patients with diabetes mellitus to decrease their hypoglycemic medications without sacrificing glycemic control."
Post hoc analyses suggested that the significant weight loss using this intervention was primarily seen in patients taking insulin.
Study limitations include poor overall compliance with the intervention, patients who frequently eat meals outside of the home being excluded from the study, lack of double blinding, and lack of data regarding quantitative dietary composition changes or caloric expenditure.
"The portion control tool studied in this trial was effective in inducing weight loss in obese persons with type 2 DM [diabetes mellitus] comparable to that seen in investigations of weight loss pharmacotherapy," the authors conclude. "This simple inexpensive tool also enabled obese patients with DM to decrease their hypoglycemic medication requirements. This intervention holds promise for use in overweight populations with and without DM."
The Stewart Diabetes Education Fund sponsored this study. The Diet Plate donated the portion control tools used in this study. The authors have disclosed no relevant financial relationships.
Arch Intern Med. 2007;167:1277-1283.
Tuesday, June 26, 2007
ASE: Diastolic Dysfunction Predicts MI or Coronary Disease Readmission
SEATTLE, June 25 -- Severe diastolic dysfunction tops all other echocardiograhic measures as a post-MI prognostic marker, researchers reported here.
The finding came from a prospective evaluation of 199 patients with a history of coronary artery disease (N=36), ST-segment elevation MI (N=118), or heart failure (N=8), according to Taiyeb Khumri, M.D., of the Mid-America Heart Institute in Kansas City.
All had complete echocardiographic assessments at index admission, he and colleagues said at the American Society of Echocardiography meeting.
In the first year after the index admission, more than three fourths of patients with severe diastolic dysfunction were readmitted for cardiovascular reasons. Evaluation of all patients readmitted during the first year showed that severe dysfunction was the only echocardiographic predictor of readmission.
Reviewing the background of the study, Dr. Khumri noted that diastolic dysfunction is a common finding after acute MI, and left-ventricular diastolic dysfunction predicts in-hospital heart failure, subsequent left-ventricular remodeling, and long-term mortality.
Although Doppler echo is useful for assessing left-ventricular diastolic function, echo-related factors associated with the risk of readmission had not been examined carefully.
Echocardiographic exams of the 199 patients showed that 18 had severely abnormal diastolic function. During the 12 months after infarction, 78% were rehospitalized. Overall, 82 of the 199 patients were rehospitalized for cardiovascular reasons within a year of their index admission.
The Kansas City investigators performed a multivariate analysis on more than 20 variables that could influence the risk of rehospitalization at 12 months. The only factors that proved to be significant predictors were education (P=0.02), peripheral arterial disease (P=0.007), previous angina (P=0.028), and severe diastolic dysfunction (P=0.018).
A total of 74 patients had a left-ventricular ejection fraction of less than 40% at the index admission. The multivariate analysis initially suggested that ejection fraction significantly influenced the risk of rehospitalization (P=0.035), but statistical confidence intervals associated with that P-value crossed the 1.0 threshold.
The finding came from a prospective evaluation of 199 patients with a history of coronary artery disease (N=36), ST-segment elevation MI (N=118), or heart failure (N=8), according to Taiyeb Khumri, M.D., of the Mid-America Heart Institute in Kansas City.
All had complete echocardiographic assessments at index admission, he and colleagues said at the American Society of Echocardiography meeting.
In the first year after the index admission, more than three fourths of patients with severe diastolic dysfunction were readmitted for cardiovascular reasons. Evaluation of all patients readmitted during the first year showed that severe dysfunction was the only echocardiographic predictor of readmission.
Reviewing the background of the study, Dr. Khumri noted that diastolic dysfunction is a common finding after acute MI, and left-ventricular diastolic dysfunction predicts in-hospital heart failure, subsequent left-ventricular remodeling, and long-term mortality.
Although Doppler echo is useful for assessing left-ventricular diastolic function, echo-related factors associated with the risk of readmission had not been examined carefully.
Echocardiographic exams of the 199 patients showed that 18 had severely abnormal diastolic function. During the 12 months after infarction, 78% were rehospitalized. Overall, 82 of the 199 patients were rehospitalized for cardiovascular reasons within a year of their index admission.
The Kansas City investigators performed a multivariate analysis on more than 20 variables that could influence the risk of rehospitalization at 12 months. The only factors that proved to be significant predictors were education (P=0.02), peripheral arterial disease (P=0.007), previous angina (P=0.028), and severe diastolic dysfunction (P=0.018).
A total of 74 patients had a left-ventricular ejection fraction of less than 40% at the index admission. The multivariate analysis initially suggested that ejection fraction significantly influenced the risk of rehospitalization (P=0.035), but statistical confidence intervals associated with that P-value crossed the 1.0 threshold.
AANP: Pain May Be a Major Factor for Sleep Disturbances in Diabetes
INDIANAPOLIS, June 25 -- A pilot study suggests that patients with long-standing type 2 diabetes should be evaluated for sleep quality. In those with sleep problems, pain should be assessed as a major contributor.
"Diabetes is a very complex disease and clinicians are so worried about things like blood sugars, high blood pressure, and heart problems that they very often don't even consider disturbed sleep," Leslie-Faith Morritt Taub, DNSc, APN-C, of the University of Medicine and Dentistry of New Jersey School of Nursing, told attendees at the annual meeting of the American Academy of Nurse Practitioners here.
"This is an extra burden for a person with chronic illness," Dr. Taub said. "We should be asking patients about their sleep patterns."
To find out the pattern of sleep disturbance, Dr. Taub and her colleague, Nancy Redeker, Ph.D., R.N., enrolled 31 patients with type 2 diabetes in a cross-sectional study. Participants were drawn from the New Jersey cohort of the Translating Research Into Action for Diabetes (TRIAD) study. Their mean age was nearly 61 and duration of illness was 14.5 years. They were 54% women and 74.2% white.
Each participant was assessed for depression, pain, sleep quality, fatigue, excessive daytime sleepiness, and medical comorbidities using well-established scales. Sleep quantity, onset, and waking after sleep onset (WASO) was measured using a wrist Actigraph. To measure nocturia, patients were asked about how often they got up at night to go to the bathroom.
Just under half the participants reported poor sleep quality and excessive sleepiness during the day, with more than one-fourth saying they had moderate to severe fatigue.
There were also large percentages of participants with possible depression and 3 or more comorbid illnesses. The average amount of pain seen for the entire group was twice that of the general population. Nearly one in three experienced nocturia two or more times a night.
A comparison of sleep variables by gender found that women had longer sleep onset latency (P=0.024), poorer efficiency of sleep (P=0.019), and shorter waking after sleep onset (P=0.049) and more fatigue (P=0.035).
When the researchers generated a model of variables that explained differences in sleep quality across the entire group, only pain reached significance (P=0.018), explaining 42% of the variance in sleep quality.
"The biggest surprise was the dichotomy we saw between men and women," said Dr. Taub. "Women actually did have poorer sleep and actually did wake up more often in the night. Not only did they complain about fatigue, but there were real measurable differences in their sleep patterns."
Dr. Taub concluded that sleep quality should be evaluated in all people with long-standing diabetes. In those with concerns, the amount and type of pain is an important contributor to sleep disturbances.
In addition, she said, complaints of fatigue, excessive sleepiness during the daytime, nocturia, and symptoms of depression should not be overlooked when investigating possible causes of sleep complaints.
Funding was provided by the University of Medicine and Dentistry of New Jersey Foundation and the UMDNJ School of Nursing. Dr. Taub reported no financial conflicts of interest.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "A pilot study of sleep in a TRIAD cohort with type 2 diabetes"
"Diabetes is a very complex disease and clinicians are so worried about things like blood sugars, high blood pressure, and heart problems that they very often don't even consider disturbed sleep," Leslie-Faith Morritt Taub, DNSc, APN-C, of the University of Medicine and Dentistry of New Jersey School of Nursing, told attendees at the annual meeting of the American Academy of Nurse Practitioners here.
"This is an extra burden for a person with chronic illness," Dr. Taub said. "We should be asking patients about their sleep patterns."
To find out the pattern of sleep disturbance, Dr. Taub and her colleague, Nancy Redeker, Ph.D., R.N., enrolled 31 patients with type 2 diabetes in a cross-sectional study. Participants were drawn from the New Jersey cohort of the Translating Research Into Action for Diabetes (TRIAD) study. Their mean age was nearly 61 and duration of illness was 14.5 years. They were 54% women and 74.2% white.
Each participant was assessed for depression, pain, sleep quality, fatigue, excessive daytime sleepiness, and medical comorbidities using well-established scales. Sleep quantity, onset, and waking after sleep onset (WASO) was measured using a wrist Actigraph. To measure nocturia, patients were asked about how often they got up at night to go to the bathroom.
Just under half the participants reported poor sleep quality and excessive sleepiness during the day, with more than one-fourth saying they had moderate to severe fatigue.
There were also large percentages of participants with possible depression and 3 or more comorbid illnesses. The average amount of pain seen for the entire group was twice that of the general population. Nearly one in three experienced nocturia two or more times a night.
A comparison of sleep variables by gender found that women had longer sleep onset latency (P=0.024), poorer efficiency of sleep (P=0.019), and shorter waking after sleep onset (P=0.049) and more fatigue (P=0.035).
When the researchers generated a model of variables that explained differences in sleep quality across the entire group, only pain reached significance (P=0.018), explaining 42% of the variance in sleep quality.
"The biggest surprise was the dichotomy we saw between men and women," said Dr. Taub. "Women actually did have poorer sleep and actually did wake up more often in the night. Not only did they complain about fatigue, but there were real measurable differences in their sleep patterns."
Dr. Taub concluded that sleep quality should be evaluated in all people with long-standing diabetes. In those with concerns, the amount and type of pain is an important contributor to sleep disturbances.
In addition, she said, complaints of fatigue, excessive sleepiness during the daytime, nocturia, and symptoms of depression should not be overlooked when investigating possible causes of sleep complaints.
Funding was provided by the University of Medicine and Dentistry of New Jersey Foundation and the UMDNJ School of Nursing. Dr. Taub reported no financial conflicts of interest.Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "A pilot study of sleep in a TRIAD cohort with type 2 diabetes"
AANP: Certain Cephalosporins May Be Safe for Patients with Penicillin Allergies
INDIANAPOLIS, June 25 -- Emerging evidence suggests that cephalosporins without a beta-lactam side chain may be safely used in patients with known allergies to penicillin.
Concerns about cross-reactivity between may not be as significant as originally thought, said Amelie Hollier, M.S.N., FNP, of Advanced Practice Education Associates in Lafayette, La., at the American Academy of Nurse Practitioners meeting here.
But the first issue, she noted, is establishing that a true allergic reaction to penicillin did occur.
"Many patients say they are allergic, but then list symptoms that do not coincide with that kind of response," she said. "It must be a true IgE-mediated reaction including bronchospasm, angioedema, hypotension, and urticaria or pruritic rash."
Even when a patient reports a previous rash, the rash is not IgE-mediated if there is neither urticaria nor pruritic rashes. In addition, she says there is no increased risk of a non-allergic rash reoccurring even with repeated courses of the same medication. So, it is currently considered safe to administer the same antibiotic, and related ones, as long as it has been confirmed that the initial reaction was not IgE-mediated.
When a true allergic reaction has been established, the next step requires a full knowledge of the chemical make-up of the specific cephalosporin under consideration. Most penicillin allergies are related to the beta-lactam side chain. In those cases, there is an increased likelihood of cross-sensitivity to those cephalosporins that also have a beta-lactam side chain.
The cephalosporin medications that are likely to cross-react after penicillin allergies have been established include:
Cephalexin
Cefadroxil
Ceflaclor
Cephradine
Cefprozil
Ceftriaxone
Cefpodoxime
Among those that lack the beta-lactam side chain, and would therefore be a safer bet, she said, are:
Cefazolin
Cefuroxime
Cefdinir
Cefixime
Ceftibuten
Hollier stressed that the risk of an allergic reaction to cephalosporins in those with an established IgE-mediated allergy to PCN is very low or non-existent, as long as the side chains are not similar.
The other side of the discussion is whether those allergic to cephalosporins can safely receive penicillin.
"The answer is that we don't know yet," said Hollier. "I usually use the anaphylaxis rule. If there was an anaphylactic response to penicillin, I would never again give cephalosporins or vice versa. The risk is just too great."
Another thing to remember when thinking about medication for patients with a penicillin allergy, Hollier said, is that there is a three-fold increased coincidental risk of adverse reactions to even an unrelated drug. They are more likely to react to any class of drug, so extra teaching and care is required.
"Within the last five years we have begun to see that penicillin and cephalosporin cross-sensitivity is not as important as we thought it once was," said Hollier. "This gives us another useful tool that we thought we had lost."
Amelie Hollier disclosed that she is a member of the Speaker's Bureau for Abbott Pharmaceuticals. Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "Antibiotics: The Path of Least Resistance"
Concerns about cross-reactivity between may not be as significant as originally thought, said Amelie Hollier, M.S.N., FNP, of Advanced Practice Education Associates in Lafayette, La., at the American Academy of Nurse Practitioners meeting here.
But the first issue, she noted, is establishing that a true allergic reaction to penicillin did occur.
"Many patients say they are allergic, but then list symptoms that do not coincide with that kind of response," she said. "It must be a true IgE-mediated reaction including bronchospasm, angioedema, hypotension, and urticaria or pruritic rash."
Even when a patient reports a previous rash, the rash is not IgE-mediated if there is neither urticaria nor pruritic rashes. In addition, she says there is no increased risk of a non-allergic rash reoccurring even with repeated courses of the same medication. So, it is currently considered safe to administer the same antibiotic, and related ones, as long as it has been confirmed that the initial reaction was not IgE-mediated.
When a true allergic reaction has been established, the next step requires a full knowledge of the chemical make-up of the specific cephalosporin under consideration. Most penicillin allergies are related to the beta-lactam side chain. In those cases, there is an increased likelihood of cross-sensitivity to those cephalosporins that also have a beta-lactam side chain.
The cephalosporin medications that are likely to cross-react after penicillin allergies have been established include:
Cephalexin
Cefadroxil
Ceflaclor
Cephradine
Cefprozil
Ceftriaxone
Cefpodoxime
Among those that lack the beta-lactam side chain, and would therefore be a safer bet, she said, are:
Cefazolin
Cefuroxime
Cefdinir
Cefixime
Ceftibuten
Hollier stressed that the risk of an allergic reaction to cephalosporins in those with an established IgE-mediated allergy to PCN is very low or non-existent, as long as the side chains are not similar.
The other side of the discussion is whether those allergic to cephalosporins can safely receive penicillin.
"The answer is that we don't know yet," said Hollier. "I usually use the anaphylaxis rule. If there was an anaphylactic response to penicillin, I would never again give cephalosporins or vice versa. The risk is just too great."
Another thing to remember when thinking about medication for patients with a penicillin allergy, Hollier said, is that there is a three-fold increased coincidental risk of adverse reactions to even an unrelated drug. They are more likely to react to any class of drug, so extra teaching and care is required.
"Within the last five years we have begun to see that penicillin and cephalosporin cross-sensitivity is not as important as we thought it once was," said Hollier. "This gives us another useful tool that we thought we had lost."
Amelie Hollier disclosed that she is a member of the Speaker's Bureau for Abbott Pharmaceuticals. Primary source: American Academy of Nurse Practitioners Annual MeetingSource reference: "Antibiotics: The Path of Least Resistance"
ADA: Lipid Effects of Diabetes Agents May Protect Arterial Function
CHICAGO, June 25 -- Lipoprotein subfraction changes may be at the root of the dyslipidemia accompanying type 2 diabetes and help explain how thiazolidinediones improve carotid intima-media thickness, researchers said.
High-density and low-density lipoprotein particle size and concentration were significantly improved with pioglitazone (Actos) compared with glimepiride (Amaryl), found Peter M. Meyer, Ph.D., of Rush Medical Center here, and colleagues.
This was revealed in their lipoprotein subfraction subanalysis of the CHICAGO (Carotid Intima-Media Thickness in Atherosclerosis Using Pioglitazone) trial, which was presented at the American Diabetes Association meeting.
The results were "consistent with a reversal of the pattern of change associated with the transition from insulin sensitivity to insulin resistance or diabetes," they said, and "may explain some of the observed decrease in carotid-intima media thickness progression in the pioglitazone group."
This prospective, double-blind study compared the two drugs in a multiracial and multiethnic population in Chicago. Participants had newly diagnosed type 2 diabetes, which was controlled by diet, or any combination of sulfonylurea, metformin, and insulin.
The 462 patients were randomized to 72 weeks of treatment with pioglitazone at a dose of 15 to 45 mg/d or glimepiride at a dose of 1 to 4 mg/d.
Among the main findings published in the Journal of the American Medical Association in 2006, the researchers reported that pioglitazone significantly slowed progression of carotid-intima media thickness compared with glimepiride (P=0.008).
The subanalysis focused on lipoprotein subfractions measured with NMR spectroscopy done on blood samples taken at baseline and periodically through the study.
"Patients with type 2 diabetes manifest a form of dyslipidemia typified by high LDL particle concentration, small LDL particle size, and high triglyceride and low HDL cholesterol levels," they said.
At 72 weeks there were significant differences favoring pioglitazone in reversing these trends although the baseline lipoprotein parameters were similar between groups.
Total LDL particle concentration was significantly improved by pioglitazone compared with glimepiride (-209.7 versus -109.3 nmol/L, P≤0.01).
LDL particle size was likewise improved with pioglitazone (0.59 versus 0.17 nm, P≤0.001). This was achieved by increasing large LDL particle concentrations and significantly reducing those of medium-small and small LDL particles (P≤0.001 for all).
Very low density lipoprotein (VLDL) particle concentration improved more overall with glimepiride but the difference between groups was not significant (-5.69 versus -1.37 nmol/L).
But, VLDL particle size decreased significantly with pioglitazone compared with glimepiride (-5.01 versus -0.69 nm, P≤0.001). This was primarily by increasing small VLDL particle concentration (7.11 versus -1.4 nmol/L, P≤0.001) while also modestly decreasing large and medium-intermediate VLDL concentrations.
Total HDL particle concentrations increased slightly with pioglitazone but decreased with glimepiride (0.21 versus -1.05 nmol/L, P≤0.001).
HDL particle size followed the same pattern (0.14 versus -0.01 nm, P≤0.001). Large and medium HDL particle concentrations increased while that of small particles decreased (all P≤0.01).
The researchers noted that the study was underpowered to compare cardiovascular event rates between groups, so it is not known whether the differences seen in carotid intima-media thickness and lipoprotein subfractions would impact outcomes.
However, "in aggregate, the changes in lipoprotein subfraction distribution would be predicted to produce a reduction in cardiovascular disease risk with pioglitazone versus glimepiride," they concluded.
High-density and low-density lipoprotein particle size and concentration were significantly improved with pioglitazone (Actos) compared with glimepiride (Amaryl), found Peter M. Meyer, Ph.D., of Rush Medical Center here, and colleagues.
This was revealed in their lipoprotein subfraction subanalysis of the CHICAGO (Carotid Intima-Media Thickness in Atherosclerosis Using Pioglitazone) trial, which was presented at the American Diabetes Association meeting.
The results were "consistent with a reversal of the pattern of change associated with the transition from insulin sensitivity to insulin resistance or diabetes," they said, and "may explain some of the observed decrease in carotid-intima media thickness progression in the pioglitazone group."
This prospective, double-blind study compared the two drugs in a multiracial and multiethnic population in Chicago. Participants had newly diagnosed type 2 diabetes, which was controlled by diet, or any combination of sulfonylurea, metformin, and insulin.
The 462 patients were randomized to 72 weeks of treatment with pioglitazone at a dose of 15 to 45 mg/d or glimepiride at a dose of 1 to 4 mg/d.
Among the main findings published in the Journal of the American Medical Association in 2006, the researchers reported that pioglitazone significantly slowed progression of carotid-intima media thickness compared with glimepiride (P=0.008).
The subanalysis focused on lipoprotein subfractions measured with NMR spectroscopy done on blood samples taken at baseline and periodically through the study.
"Patients with type 2 diabetes manifest a form of dyslipidemia typified by high LDL particle concentration, small LDL particle size, and high triglyceride and low HDL cholesterol levels," they said.
At 72 weeks there were significant differences favoring pioglitazone in reversing these trends although the baseline lipoprotein parameters were similar between groups.
Total LDL particle concentration was significantly improved by pioglitazone compared with glimepiride (-209.7 versus -109.3 nmol/L, P≤0.01).
LDL particle size was likewise improved with pioglitazone (0.59 versus 0.17 nm, P≤0.001). This was achieved by increasing large LDL particle concentrations and significantly reducing those of medium-small and small LDL particles (P≤0.001 for all).
Very low density lipoprotein (VLDL) particle concentration improved more overall with glimepiride but the difference between groups was not significant (-5.69 versus -1.37 nmol/L).
But, VLDL particle size decreased significantly with pioglitazone compared with glimepiride (-5.01 versus -0.69 nm, P≤0.001). This was primarily by increasing small VLDL particle concentration (7.11 versus -1.4 nmol/L, P≤0.001) while also modestly decreasing large and medium-intermediate VLDL concentrations.
Total HDL particle concentrations increased slightly with pioglitazone but decreased with glimepiride (0.21 versus -1.05 nmol/L, P≤0.001).
HDL particle size followed the same pattern (0.14 versus -0.01 nm, P≤0.001). Large and medium HDL particle concentrations increased while that of small particles decreased (all P≤0.01).
The researchers noted that the study was underpowered to compare cardiovascular event rates between groups, so it is not known whether the differences seen in carotid intima-media thickness and lipoprotein subfractions would impact outcomes.
However, "in aggregate, the changes in lipoprotein subfraction distribution would be predicted to produce a reduction in cardiovascular disease risk with pioglitazone versus glimepiride," they concluded.
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