Boehringer Ingelheim announces Phase III data of flibanserin in pre-menopausal women with HSDD

Ridgefield, CT,17 nov 2009- Data from pivotal Phase III clinical trials demonstrate that flibanserin 100mg increased the number of satisfying sexual events (SSE) and sexual desire (the co-primary endpoints) while decreasing the distress associated with Hypoactive Sexual Desire Disorder (HSDD). Flibanserin is an investigational compound being developed by Boehringer Ingelheim for the treatment of HSDD in pre-menopausal women. HSDD is a decrease or lack of sexual desire that causes distress for the patient, may put a strain on relationships with partners, and is not due to the effects of a substance, including medications, or another medical condition.

The findings, presented at the 12th Congress of the European Society for Sexual Medicine in Lyon, France, include data from a pre-specified pooled analysis of two pivotal North American trials (DAISY® and VIOLET®) assessing flibanserin 100mg in pre-menopausal women suffering from HSDD.

"HSDD is a complex condition that can cause distress and negatively impact a woman's self-esteem," said Anita Clayton, MD, one of the lead study authors and professor of psychiatry and neurobehavioral sciences, University of Virginia. "With this data, we are making exciting progress in women's sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women. This is an important milestone for an under-recognized condition for which there is no FDA-approved treatment."

North American Phase III Trial Results

In the pooled analysis of 1,378 pre-menopausal women with HSDD, the frequency of SSE increased significantly in women taking flibanserin 100mg (increasing from 2.8 at baseline to 4.5 at study end) versus placebo (2.7 at baseline increasing to 3.7 at study end) over the 24-week study period. Flibanserin also demonstrated statistically significant improvements in sexual desire versus placebo as measured by a daily electronic diary (eDiary) and the Female Sexual Function Index (FSFI) desire domain.

Flibanserin significantly improved sexual functioning (as measured by the FSFI total score), distress related to sexual dysfunction (as measured by the Female Sexual Distress Scale-Revised, FSDS-R, score) and distress related to low sexual desire (the score on FSDS-R question 13) versus placebo, which were secondary endpoints.

The most commonly reported adverse events (AEs) with flibanserin 100mg were mild to moderate and emerged during the first 14 days of treatment. These AEs reported by more women on flibanserin than on placebo included somnolence (daytime sleepiness), dizziness, fatigue, anxiety, dry mouth, nausea and insomnia. The majority of these AEs resolved with continued treatment. About 15 percent of women on flibanserin 100mg and seven percent of women on placebo discontinued treatment due to AEs.

"Sexual desire disorders can affect women of all ages, at any stage of life," said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Boehringer Ingelheim is pleased to present this data, which provides valuable scientific knowledge about HSDD."

About the North American Phase III Trial

The North American Phase III clinical trial studied flibanserin at 25, 50 and 100mg doses. The pre-specified pooled analysis included data from two 24-week randomized, placebo-controlled North American trials. The analysis involved women with generalized, acquired HSDD who were treated with flibanserin 100mg or placebo. Flibanserin 100mg increased the number of SSE and sexual desire and decreased distress associated with HSDD. The women in the study were in stable, communicative, monogamous, heterosexual relationships with a sexually-functional partner for at least one year and were required to use a reliable form of contraception. About 40 percent of women were on some form of hormonal contraception.

In the North American pivotal trials, the co-primary endpoints were changes from a four-week baseline period to week 21 to 24 in sexual desire score and in the number of SSE, as recorded daily by patients using an electronic diary (eDiary For HSDD Trials). Both are patient reported outcome measures. SSE measures the number of sexual events (defined as sexual intercourse, oral sex, masturbation or genital stimulation by the partner), and whether each event was satisfying for the woman (i.e. gratifying, fulfilling, satisfactory and/or successful).

The FSFI and FSDS-R desire scores - independently developed and validated tools - were included as secondary endpoints to provide additional measurement of changes in desire over a four-week recall period. The FSFI is a 19-item self-administered questionnaire composed of six domains (desire, arousal, lubrication, orgasm, satisfaction, and pain). The FSDS-R is a 13-item self-administered questionnaire. The total score ranges from zero to 52, with the higher scores indicating more sexual distress. Additionally, Boehringer Ingelheim designed the eDiary For HSDD Trials to measure levels of desire on a daily basis.

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About Hypoactive Sexual Desire Disorder

HSDD is a form of female sexual dysfunction (FSD). As defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR), HSDD is the persistent lack (or absence) of sexual fantasies or desire for any form of sexual activity causing marked distress or interpersonal difficulty and not better accounted for by another disorder (except another sexual dysfunction), direct physiological effects of a substance (including medications), or a general medical or psychiatric condition. Generalized, acquired HSDD is not limited to certain types of stimulation, situations or partners, and develops only after a period of normal functioning. Sexual Desire Disorders are generally under-diagnosed.

Study Finds Features Linked to Mortality Risk in Parkinson's


Cognitive impairment, dysphagia, postural instability gait difficulty associated with risk

16 nov 2009-- A variety of motor and non-motor factors may be associated with a higher risk of mortality in patients with early Parkinson's disease, according to research published in the November issue of the Archives of Neurology.

Raymond Y. Lo, M.D., of the Parkinson's Institute and Clinical Center in Sunnyvale, Calif., and colleagues analyzed Kaiser Permanente Medical Care Program data on 573 subjects with Parkinson's disease that was newly diagnosed during 1994 and 1995. Subjects were followed for death until the end of 2005.

During follow-up, the researchers note that 352 subjects died. Factors associated with a higher risk of all-cause mortality included severe cognitive impairment based on Mini-Mental State Examination scores, symmetry of motor signs, older age at diagnosis, dysphagia, and postural instability gait difficulty subtype (hazard ratios, 2.7, 2.0, 1.1, 1.4, and 1.8, respectively).

"In this multiethnic incident Parkinson's disease cohort, we conclude that several motor and non-motor features in early Parkinson's disease can predict higher mortality risk, particularly older age at diagnosis, postural instability gait difficulty, cognitive impairment, and hallucinations. Our findings are in keeping with those of others, suggesting that these results are robust and generalizable. With effective clinical predictors, we can improve understanding of the disease process, refine risk stratification in designing clinical trials, and guide decision making in clinical practice," the authors conclude.

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Clopidogrel Can Be Effective in Reducing Cardiac Risk


Drug shown to reduce the risk of cardiovascular events in both men and women

16 nov 2009-- The antiplatelet drug clopidogrel is likely effective in reducing the risk of cardiovascular events in both men and women, according to a study in the Nov. 17 issue of the Journal of the American College of Cardiology.

Jeffrey S. Berger, M.D., of the New York University School of Medicine in New York City, and colleagues performed a meta-analysis of five randomized clinical trials involving 79,613 patients (30 percent women) that examined the safety and efficacy of clopidogrel at reducing cardiovascular events.

The researchers found that clopidogrel significantly reduced the risk of cardiovascular events by 14 percent (odds ratio, 0.86), with similar efficacy in men and women. Clopidogrel significantly reduced the risk of myocardial infarction in both women and men (odds ratios, 0.81 and 0.83, respectively). In men, clopidogrel also reduced the risk of stroke (odds ratio, 0.83) and total death (odds ratio, 0.91), while in women the effects were not statistically significant. In addition, clopidogrel increased the risk of major bleeding in both men and women (odds ratios, 1.22 and 1.43, respectively).

"The cumulative evidence continues to show that women with coronary artery disease differ from men in many important ways, including the response to antiplatelet therapy," the author of an accompanying editorial writes. "The good news is that clopidogrel is an exception."

Several authors of the article and editorial reported financial and consulting relationships with pharmaceutical companies.

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Elderly Slow Walkers at More Risk of Cardiovascular Death

Study finds association applies regardless of sex, body mass index or age

15 nov 2009-- Elders who walk slowly are more likely to die of cardiovascular disease than their faster walking counterparts, regardless of age, sex, body mass index or the amount of physical activity they engage in, according to a study published Nov. 10 in BMJ.

Julien Dumurgier, M.D., of INSERM in Paris, and colleagues conducted a study of 3,208 community-dwelling men and women aged 65 years and above who were followed up for an average of 5.1 years.

During follow-up, 209 participants died, 99 due to cancer and 59 from cardiovascular disease, while 51 died from other causes, the researchers found. There was a higher risk of mortality among the lowest third based on walking speed versus the upper two-thirds (hazard ratio, 1.44), and the risk of cardiovascular death among slow walkers increased about three-fold compared to the risk for faster walkers, while there was no increased risk of cancer mortality noted.

"This increased risk of cardiovascular death was seen in both sexes, younger as well as in older participants, those with or without a high risk vascular profile, and those with low or usual physical activity," the authors write. "These findings show that assessment of motor performances in older people with simple measures such as walking speed can be performed easily and that the role of fitness in preserving life and function in older age is important."

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Muscle Strength May Lower Alzheimer's Disease Risk

Study finds increased muscle strength likely decreases cognitive decline in elderly

15 nov 2009-- Older individuals with greater muscular strength may have a lower risk of developing mild cognitive impairment and Alzheimer's disease, according to research published in the November issue of the Archives of Neurology.

Patricia A. Boyle, Ph.D., of the Rush Alzheimer's Disease Center in Chicago, and colleagues analyzed data from 970 subjects free of dementia at baseline. Participants underwent measurement of the strength of numerous muscle groups, which were used to create a composite strength measure. Subjects had a mean age of 80.3 years and were followed for a mean of 3.6 years.

The researchers found that each unit of additional muscle strength at baseline was associated with a 43 percent lower risk of Alzheimer's disease. Those in the 90th percentile for strength had about a 61 percent lower risk compared to those in the 10th percentile. In addition, increased muscle strength was associated with a lower risk of mild cognitive impairment, with those in the 90th percentile having approximately a 48 percent lower risk.

"These findings suggest a link between muscle strength, Alzheimer's disease, and cognitive decline in older persons," the authors conclude. "The basis of the association of muscle strength with Alzheimer's disease is unknown. Although decreased muscle strength may represent a true risk factor for Alzheimer's disease, it is more likely that loss of muscle strength is the result of an underlying disease process that also leads to cognitive decline and clinical Alzheimer's disease."

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More Disabilities Today In 60-Year-Olds Than In Prior Generations

14 nov 2009--In a development that could have significant ramifications for the nation's health care system, Baby Boomers may well be entering their 60s suffering far more disabilities than their counterparts did in previous generations, according to a new UCLA study. The findings, researchers say, may be due in part to changing American demographics.

In the study, which will be published in the January 2010 issue of the American Journal of Public Health, researchers from the division of geriatrics at the David Geffen School of Medicine at UCLA found that the cohort of individuals between the ages of 60 and 69 exhibited increases in several types of disabilities over time. By contrast, those between the ages of 70 and 79 and those aged 80 and over saw no significant increases - and in some cases exhibited fewer disabilities than their previous cohorts.

While the study focused on groups born prior to the post-World War II Baby Boom, the findings hold "significant and sobering implications" for health care because they suggest that people now entering their 60s could have even more disabilities, putting an added burden on an already fragile system and boosting health costs for society as a whole, researchers say.

If this is true, it's something we need to address," said Teresa Seeman, UCLA professor of medicine and epidemiology and the study's principal investigator. "If this trend continues unchecked, it will put increasing pressure on our society to take care of these disabled individuals. This would just put more of a burden on the health care system to address the higher levels of these problems."

The researchers used two sets of data - the National Health and Nutrition Examination Surveys (NHANES) for 1988 and 1999 - to examine how disabilities for the three groups of adults aged 60, 70, and 80 and older had changed over time. They assessed disability trends in four areas: basic activities associated with daily living, such as walking from room to room and getting into and out of bed; instrumental activities, such as performing household chores or preparing meals; mobility, including walking one-quarter mile or climbing 10 steps without stopping for rest; and functional limitations, which include stooping, crouching or kneeling.

The study focused primarily on trends for the more recent 60 age group - those born between 1930 and 1944, just before the start of the Baby Boom, whose data was included in the 1999 NHANES. In particular, researchers felt this group could offer insights into the health of the Boomers following them, who are now entering their 60s.

The researchers found that between the periods 1988 and 1999, disability among those in their 60s increased between 40 and 70 percent in each area studied except functional limitations, independent of sociodemographic characteristics, health status and behaviors, and relative weight. The increases were considerably higher among non-white and overweight subgroups.

By contrast, the researchers found no significant changes among the group aged 70 to 79, while the 80-plus group actually saw a drop in functional limitations.

One reason for this uptick, researchers say, is that disabilities may be linked with the changing racial and ethnic makeup of the group that recently reached or will soon be reaching its 60s, with the most rapid growth projected to be among African Americans and Hispanics - groups with significantly higher rates of obesity and lower socioeconomic status, both of which are associated with higher risk for functional limitations and disabilities.

The researchers note that their controls for differences in sociodemographics, health status (such as chronic conditions and biological risk factors) and health behavior do not completely explain the increase in disability trends among the 60- to 69-year olds. Still, the trends within that group "are disturbing," Seeman said.

"Increases in disability in that group are concerning because it's a big group," she said. "These may be people who have longer histories of being overweight, and we may be seeing the consequences of that. We're not sure why these disabilities are going up. But if this trend continues, it could have a major impact on us, due to the resources that will have to be devoted to those people."

Study co-authors included Arun Karlamangla and Sharon Merkin, of UCLA's geriatrics division, and Eileen Crimmins, of the Andrus Gerontology Center at the University of Southern California.

The National Institute on Aging funded this study.

Source: Enrique Rivero
University of California - Los Angeles

Lack Of Social Engagement Is A Risk Factor For Self Neglect In Older Adults

14 nov 2009--Seniors who neglect themselves, risking their own health and safety, tend to be individuals with limited social networks and little social engagement, according to a study by Rush University Medical Center.

The study, currently appearing online in the medical journal Gerontology, is the largest epidemiological study to date examining a wide range of sociodemographic, health-related and psychosocial characteristics associated with elder self-neglect.

"We need to better understand elder self-neglect who is at risk and why so that we can find solutions and establish appropriate policies," said Dr. Xinqi Dong, a researcher and geriatrician at Rush University Medical Center and the study's lead author. "This is particularly important because reports of self-neglect to social service agencies are rising.

"Moreover, as our aging population is rapidly increasing in size, elder self-neglect will likely become an even more pervasive public health issue."

The study was based on records drawn from the Chicago Health and Aging Project, a longitudinal epidemiological study of a community-dwelling population of 9,056 individuals 65 years of age and older who live in three communities on Chicago's South side.

Over the 12-year course of this population-based study, 1,812 of these seniors, or 20 percent, were reported to the Chicago Department of Aging because of concern about suspected self-neglect.

Elder self-neglect is defined by the National Centers on Elder Abuse as "the behavior of an elderly person that threatens his/her own health and safety." It generally manifests as "a refusal or failure by the person to provide himself/herself with adequate food, water, clothing, shelter, personal hygiene, medication and safety precautions."

Twice as many women as men and more than seven times the number of African Americans as whites were reported for self-neglect. Those reported, compared with those not reported, tended to be over the age of 80 and have a lower socioeconomic status. The individuals also tended to have nutritional deficiencies, medical conditions and cognitive, physical and psychological deficits.

However, independent of all these factors, lower levels of social well-being specifically, limited social networks and little social engagement were major risk factors for self-neglect.

The study has important implications for health and social service professionals, Dong said.

"Professionals who work with the elderly need to be mindful not just of their patients' health profile, but also of their social well-being, a factor that may put them at risk of self-neglect," Dong said. "With social services being cut, and community and city resources lacking to help seniors, the problems of isolation can only grow worse."

Dong will be testifying before the City Council of Chicago on November 13 in support of a resolution seeking to identify measures to address the problem of elder self-neglect. The resolution has been submitted by Alderman Emma Mitts of the 37th Ward and is supported by 29 other Chicago aldermen.

Other researchers involved in the study were Dr. Denis Evans at Rush and Dr. Melissa Simon at Northwestern University.

The study was supported by the National Institute on Aging, a Paul B. Beeson Career Development Award in Aging, The Starr Foundation, the John A. Hartford Foundation and The Atlantic Philanthropies.

Rush University Medical Center includes a 674-bed (staffed) hospital; the Johnston R. Bowman Health Center; and Rush University (Rush Medical College, College of Nursing, College of Health Sciences and the Graduate College).

Rush is currently constructing a 14-floor, 806,000-square-foot hospital building at the corner of Ashland Avenue and Congress Parkway. The new hospital, scheduled to open in 2012, is the centerpiece of a $1-billion, 10-year campus redevelopment plan called the Rush Transformation, which also includes a new orthopedics building (to open in Fall 2009), a new parking garage and central power plant completed in June 2009, renovations of selected existing buildings and demolition of obsolete buildings. The new hospital is being designed and built to conserve energy and water, reduce waste and use sustainable building materials. Rush is seeking Leadership in Energy and Environmental Design (LEED) gold certification from the U.S. Green Building Council. It will be the first full-service "green" hospital in Chicago.

Rush's mission is to provide the best possible care for our patients. Educating tomorrow's health care professional, researching new and more advanced treatment options, transforming our facilities and investing in new technologies all are undertaken with the drive to improve patient care now, and for the future.

Source: Rush University Medical Center

For Older Walkers, Faster Is Better

13 nov 2009-- Highlighting the importance of staying fit in old age, a French study has found that seniors who walk slowly are three times more likely to die from cardiovascular disease than are fast walkers.

The researchers measured the walking speed of the participants -- 3,208 men and women, ages 65 to 85 -- and collected medical and demographic information on them at the start of the study. Follow-up exams were performed at regular intervals over the next five years.

After adjusting for a number of baseline characteristic, the researchers found that seniors with the slowest walking speed were 44 percent more likely to die than the fastest walkers. The slowest walkers also had a three-fold higher risk of cardiovascular death.

The increased risk of cardiovascular death was found in both women and men, in younger as well as older seniors and in those with low or usual physical activity levels.

There was no link between walking speed and risk of death from cancer.

"These findings show that assessment of motor performances in older people using simple measures such as walking speed can be performed easily and that the role of fitness in preserving life and function in older age is important," the researchers wrote.

The study was published online Nov. 10 in BMJ.

Longevity tied to genes that preserve tips of chromosomes

Findings from Einstein study of healthy centenarians

13 nov 2009 - A team led by researchers at Albert Einstein College of Medicine of Yeshiva University has found a clear link between living to 100 and inheriting a hyperactive version of an enzyme that rebuilds telomeres – the tip ends of chromosomes. The findings appear in the latest issue of the Proceedings of the National Academy of Sciences.

Telomeres play crucial roles in aging, cancer and other biological processes. Their importance was recognized last month, when three scientists were awarded the 2009 Nobel Prize in Physiology and Medicine for determining the structure of telomeres and discovering how they protect chromosomes from degrading.

Telomeres are relatively short sections of specialized DNA that sit at the ends of all chromosomes. One of the Nobel Prize winners, Elizabeth Blackburn, Ph.D., of the University of California at San Francisco, has compared telomeres to the plastic tips at the ends of shoelaces that prevent the laces from unraveling.

Each time a cell divides, its telomeres erode slightly and become progressively shorter with each cell division. Eventually, telomeres become so short that their host cells stop dividing and lapse into a condition called cell senescence. As a result, vital tissues and important organs begin to fail and the classical signs of aging ensue.

In investigating the role of telomeres in aging, the Einstein researchers studied Ashkenazi Jews because they are a homogeneous population that was already well studied genetically. Three groups were enrolled: 86 very old – but generally healthy – people (average age 97); 175 of their offspring; and 93 controls (offspring of parents who had lived a normal lifespan).

"Telomeres are one piece of the puzzle that accounts for why some people can live so long," says Gil Atzmon, Ph.D., assistant professor of medicine and of genetics at Einstein, Genetic Core Leader for The LonGenity Project at Einstein's Institute for Aging Research, and a lead author of the paper. "Our research was meant to answer two questions: Do people who live long lives tend to have long telomeres? And if so, could variations in their genes that code for telomerase account for their long telomeres?"

The answer to both questions was "yes."

"As we suspected, humans of exceptional longevity are better able to maintain the length of their telomeres," said Yousin Suh, Ph.D., associate professor of medicine and of genetics at Einstein and senior author of the paper. "And we found that they owe their longevity, at least in part, to advantageous variants of genes involved in telomere maintenance."

More specifically, the researchers found that participants who have lived to a very old age have inherited mutant genes that make their telomerase-making system extra active and able to maintain telomere length more effectively. For the most part, these people were spared age-related diseases such as cardiovascular disease and diabetes, which cause most deaths among elderly people.

"Our findings suggest that telomere length and variants of telomerase genes combine to help people live very long lives, perhaps by protecting them from the diseases of old age," says Dr. Suh. "We're now trying to understand the mechanism by which these genetic variants of telomerase maintain telomere length in centenarians. Ultimately, it may be possible to develop drugs that mimic the telomerase that our centenarians have been blessed with."

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The study, "Genetic Variation in Human Telomerase is Associated with Telomere Length in Ashkenazi Centenarians," appears in the November 9 online issue of the Proceedings of the National Academy of Sciences. In addition to Drs. Atzmon and Suh, the study's other Einstein researchers were co-lead author Miook Cho, M.S., Temuri Budagov, M.S., Micol Katz, M.D., Xiaoman Yang, M.D., Glenn Siegel, M.D., Aviv Bergman, Ph.D., Derek M. Huffman, Ph.D., Clyde B. Schechter, M.D., and Nir Barzilai, M.D.

Few Americans make end-of-life wishes known

FORT LAUDERDALE, Fla., 12 nov 2009 – Lillian Landry always said she wasn't afraid to die. So when death came last week, the 99-year-old was lying peacefully in a hospice with no needles or tubes. Her final days saw her closest friend at her side and included occasional shots of her favorite whiskey, Canadian Mist.

Landry is an exception. Unlike most Americans, she made her end-of-life decisions years ago: no heroic measures to save her and even instructions on the bar where mourners should gather.

The health overhaul bill that narrowly passed the House on Saturday includes a provision to nudge more people to confront such choices: It would pay for end-of-life counseling for Medicare patients.

Supporters say counseling would give patients more control and free families from tortuous decisions. Critics have warned it could lead to government "death panels." What few on either side note is that counseling could lead more people to choose less intensive care when they're dying, and ultimately trim government-funded health bills.

Hospice care has grown from about 25,000 patients in 1982, when Congress approved coverage under Medicare, to 1.45 million people in 2008. It's for patients who have a prognosis of no more than six months — and it ranges from in-home care to stand-alone centers to special wings in hospitals. It does nothing to artificially lengthen or shorten life, focusing mostly on a patient's comfort.

People on Medicare account for the vast majority of U.S. deaths, and care in the last year of life accounts for roughly a quarter of Medicare's budget. So increased use of hospice could mean sizable savings for the government, particularly if patients enter it sooner.

A 2007 study published in the journal Social Science and Medicine found that among Medicare patient deaths, those who used hospice saved taxpayers an average $2,309 over their last year. In some cases, the savings were as much as $7,000, depending on the illness and length of hospice stay.

Still, only about 39 percent of Americans who died last year were in hospice. The average patient spent a little more than two months under that care; about a third moved to hospice only in the last week of life.

"It's significantly underutilized. People are referred very late," said Dr. Richard Payne, a Duke University professor who heads the school's Institute on Care at the End of Life.

"Our culture just doesn't tolerate talking about death and dying. And the minute you even start talking about having conversations with a doctor, it's immediately pejoratively labeled as 'You're trying to kill me.'"

That perception is precisely what got affixed to the counseling measure in the House bill. Even though the legislation specifies counseling wouldn't force patients to limit efforts to keep them alive, and even with the support of the American Medical Association, AARP and others, suspicion has lingered, encouraged by conservative voices including Sarah Palin.

Dr. Jim Small, a Denver pathologist who belongs to the Christian Medical and Dental Associations, said he feared the provision would be twisted into something more intrusive if bureaucrats lay out the details.

"It's incredible micromanagement," Small said. "End-of-life discussions are part of normal, good patient care, but there's no reason for it to be in the bill."

Even when patients do opt for less invasive, potentially cheaper care, there are limitations. Predicting when someone will die is notoriously inexact. Terminal patients can live for years. So deciding on less intensive treatment isn't always an easy choice.

"The concept of the last year of life is entirely retrospective," said Donald Taylor, a public policy professor at Duke who was the lead author of the study looking at hospice's cost savings. "It's just not that clear when people are dying."

Among those for whom death is clearly imminent, though, advocates argue hospice offers a more compassionate approach.

Dr. Joel Policzer is medical director for VITAS Innovative Hospice Care, which runs the hospice wing at Florida Medical Center where Landry spent her final days. Many of the patients have been hospitalized repeatedly, often getting arguably unnecessary tests before finally succumbing. He characterizes the American medical perspective as "Do something! Do something! Do something!"

Often, Policzer says, a dying elderly patient may have wanted less invasive care. But it doesn't happen.

"It doesn't happen because people are never asked. If they were, people would tell you they want to die at home in bed, surrounded by their family, their friends and their pets," he said. "People who are dying do not need to have needles shoved in them two or three times a day. It's not going to make a difference."

On a recent morning, Policzer stopped to check on 76-year-old Walter Norton, who lay frail and silent in his hospice bed. He had made numerous trips to the emergency room before his family turned to hospice. He had dementia and was suffering from pneumonia and dehydration.

No one's sure exactly what Norton would have wanted. "He wasn't asked, 'What do you want to have done?'" Policzer said.

Five days later, Norton was dead.

Landry, on the other hand, had thought about life's ending years ago.

Four days before she died, her closest friend, Joe Takach, was sitting in a recliner beside her. Her head was tilted, her mouth open and her left hand lay across her waist atop a crisp white sheet.

End-stage heart disease brought hospice care to Landry's home in July; she entered the inpatient unit in late October. Until then, she had continued her routine, going to church every week, making coffee in the morning, sitting for hours in a swivel chair watching birds and squirrels from her bedroom window. She'd make four-course dinners and sometimes stay up talking with Takach until 2 a.m.

Landry had moved in with Takach after Hurricane Wilma destroyed her home four years ago; the 49-year-old retired police dispatcher said it was like having a grandmother again.

He called her the Energizer Bunny. She called herself a tough New Englander.

"You OK?" Takach asked her in one of their final meetings. "I'm OK," she said in a soft, garbled voice, her eyes opened just a slit.

"You don't have any pain?" he asked. "No," she said.

Had Landry not made her wishes known, she likely would have been subjected to CT scans, blood tests, IVs and a feeding tube.

"She would not want that," Takach said. "She would say, 'Enough!'"

Study: Kidney angioplasty brings risks, no benefit

12 nov 2009--If you're among the hundreds of thousands of Americans with clogged kidney arteries, you might want to consider trying medicines before rushing into angioplasty to open them up. The pricey procedure is no more effective and carries surprisingly big risks, a study found.

The National Kidney Foundation estimates more than 250,000 Americans have narrowing of the arteries that supply blood to the kidneys. It's usually caused by a buildup of fatty plaque, mostly in folks 50 or older, and can result in high blood pressure and, sometimes, kidney failure. Each year, about one in six patients with the condition dies.

About 16 percent of patients with newly diagnosed blockages in kidney blood vessels undergo angioplasty or, occasionally, more-invasive artery bypass surgery. But rushing to get blood vessels cleaned out could be a dangerous mistake, according to a British study and some experts.

Doctors at several British hospitals and universities compared patients with severe kidney artery blockages who were treated just with medicines with a group that got the same drugs and underwent angioplasty, in which a catheter is threaded through an artery to clear out blockages. The angioplasty group fared no better — and some of those patients suffered serious complications, including deaths and amputations.

"There really was no benefit," said Dr. Harlan Krumholz, a cardiologist and health outcomes researcher at Yale University. "What's remarkable is that this procedure got so popular and adopted into widespread use before a study like this was conducted to show us what its value might be."

He said doctors believe some treatments have obvious benefits, but recently a series of studies like this one have upended conventional wisdom. That means precious health care dollars are being wasted and patients are enduring unnecessary procedures and risks.

In the study, published in Thursday's New England Journal of Medicine, all the patients were treated with drugs to lower cholesterol, control blood pressure and prevent blood clots.

Nearly 400 only got drugs. Another 335 patients also underwent angioplasty, which is most often done for clogged heart arteries. Nearly all of them had a stent, a tiny metal-mesh scaffold, inserted to keep the kidney artery open.

After an average of about three years, the researchers found the two groups had similar rates of death, heart attack, stroke, heart failure and decline of kidney function leading to a transplant or the start of dialysis. But 20 percent of patients getting angioplasty had a related complication in the first month, including two deaths, three amputations of toes or limbs, five cases of sudden kidney failure and four hospitalizations for internal bleeding.

Overall, patients in the two groups had the same rates of heart and kidney problems and death over the entire study period.

This report "is the first hint" that medication may produce equal results to angioplasty, said Dr. Leslie Spry, a kidney foundation spokesman. He said there's an ongoing U.S. study of the same issue.

The foundation's president, Dr. Bryan Becker, said the patients getting angioplasty may not have fared better because they had blockages in small blood vessels in addition to the blocked large blood vessels feeding the kidneys that were cleared out.

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On the Net:

New England Journal: http://www.nejm.org

Lifestyle Choices Vs. Life Expectancy: Carnegie Mellon Researchers Link Health-Care Debate To Risk Of Dying In US And Europe

10 nov 2009--The current health care debate in the United States is complicated. Trade-offs between heath care expenditures, lifestyle choices and life expectancy have been suggested but seldom clearly demonstrated. The U.S. spends on average more than $45,000 per year on health care for every 80 year old, while the Europeans spend $12,000 for the same age group. U.S. octogenarians have a 20 percent less chance of dying than Europeans in the next year. But, more than 30 percent of the U.S. population is obese, compared to less than 10 percent of Europe's population. "Many of the lifestyle choices that we make as adults have negative health consequences," said Paul Fischbeck, professor of social and decision sciences and engineering and public policy at Carnegie Mellon University. "But once we reach retirement age, it appears that differences in the medical systems start to favor the U.S."

The costs of U.S. policy are staggering. If the U.S. had the same per capita health expenditures for retirees as Germany or the United Kingdom, our country's total health care costs for all citizens would be about 40 percent less.

"The differences between U.S. and Europe in health care expenditures could not be starker," Fischbeck said. "Starting at age 65, per capita U.S. expenditures skyrocket, resulting in many hundreds of billions of dollars being spent over our European counterparts after matching population sizes."

Tough health care policy decisions revolve around cost-benefit trade-offs. A variety of factors would have to be weighed if the country shifted the emphasis from care for the elderly to polices that favor earlier preventive and lifestyle choices.

"A shift in policy could lead to more people reaching age 65, but once there, facing a higher chance of dying," Fischbeck said. "In fact, if the U.S. had Germany's death rates, we would see 150,000 more annual deaths of those over 80."

A new Web site, www.DeathriskRankings.com, developed by researchers and students at Carnegie Mellon allows users to explore differences in the probability of dying across European countries and U.S. states for men and women of different ages and races.

"When our risk data is coupled with health care cost estimates from other sources, surprising results are found," Fischbeck said. "It is only by comparing the reduction of risk associated with the additional costs that good policy choices can be made."

The research shows that prostate cancer, which has few lifestyle risk factors, is a much greater killer in Europe. In 11 European countries (including Sweden, Norway, Switzerland, Denmark, Netherlands and the United Kingdom) a man in his 70s has a higher chance of dying from prostate cancer than a man in Mississippi, the U.S. state with the highest risk. When compared to residents of Hawaii, the U.S. state with the lowest prostate cancer risk, Europeans are two to three times more likely to die from prostrate cancer.

The tables are reversed when comparing the diabetes death risk for men in their 70s, a risk highly related to lifestyle choices and obesity. Fifteen European countries (including Greece, the United Kingdom, Norway, Germany and France) have lower risks than Iowa, the U.S. state with the lowest risk. Louisiana, the U.S. state with the highest risk, has a risk that is 10 times greater than Iceland, the lowest risk European country for diabetes.

Similar risk comparisons are possible for women. The risks for breast cancer are lower in the U.S. For 50-, 60- or 70-year-olds, four to eight European countries (including Denmark, Netherlands and the United Kingdom) have a higher risk of dying of breast cancer than either New Jersey or Louisiana, the two U.S. states that tie with the highest risk.

But for lung cancer, the results are opposite. For 80-year-old women, 14 European countries have lower lung cancer death risks than Utah, the U.S. state with the lowest risk, which also has a very low smoking rate. In fact, 42 U.S. states have a higher lung cancer risk than Iceland, the European country with the highest risk. Nevada, the state with the highest lung cancer risk for 80-year-old women is eight times higher than for Spain, the European country with the lowest risk.

Where is it better to live to reach certain milestones? For men and women under 65, the risks of dying before 65 are higher in the U.S. But for men older than 56 and woman older than 75 who want to make it to 85, the U.S. is the better location.

"When it comes to health care, there are no easy choices. We hope that adding data to the debate will help make the final policies better," Fischbeck said.

Source: Chriss Swaney
Carnegie Mellon University

Does prostate-specific antigen velocity help in early detection prostate cancer?

European Urology article discusses results from large study

Arnhem, 10 nov 2009– The November issue of European Urology, the official journal of the European Association of Urology, features an article focussing on prostate specific antigen (PSA) velocity and early cancer detection. It has been suggested that changes in PSA over time aid prostate cancer detection.

It is argued that a rapidly rising PSA may indicate a greater risk of diagnosis of prostate cancer even if PSA levels are low. Some guidelines do incorporate PSA velocity cut points as an indication for biopsy. Professor A.J. Vickers of the Memorial Sloan-Kettering Cancer Center, Department of Medicine in New York (US): "Thus our aim was to evaluate whether PSA velocity indeed enhances the prediction of biopsy outcome in a large, representative, population-based cohort."

There were 2742 screening-arm participants with PSA <3>

Professor Vickers: "Our study has several strengths. It included a very large number of men in a randomized trial, who were therefore subject to highly standardized testing and follow-up procedures. We avoided verification bias and addressed the key question of whether PSA velocity adds information beyond that provided by PSA alone. We also used decision analysis to examine the clinical impact of decisions based on PSA velocity".

The conclusion of the study is that PSA velocity adds very little predictive value for determining the outcome of a first prostate biopsy in men with elevated PSA. These findings are very similar to those of earlier studies. "Accordingly, we see little justification for formal calculation of PSA velocity and subsequent incorporation into a statistical model, and no justification for velocity cut points, in determining indication for biopsy. This suggests that current guidelines on the use of PSAV to guide biopsy should be revised. However, we encourage use of clinical judgment in decisions about biopsy: A sudden rise in PSA might suggest prostatitis, triggering further evaluation of symptoms, laboratory tests, or empirical antibiotic therapy. If evidence of prostatitis is absent, a biopsy might well be advisable. This type of sophisticated, sequential, clinical decision making cannot easily be evaluated in analyses of population-based screening studies", says Professor Vickers.

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Prostate-Specific Antigen Velocity for Early Detection of Prostate Cancer: Result from a Large, Representative, Population-based Cohort
Andrew J. Vickers, Tineke Wolters, Caroline J. Savage, Angel M. Cronin, M. Frank O'Brien, Kim Pettersson, Monique J. Roobol, Gunnar Aus, Peter T. Scardino, Jonas Hugosson, Fritz H. Schröder, Hans Lilja
European Urology, Volume 56, issue 5, pages 753-890, November 2009

About the European Association of Urology (EAU)

The European Association of Urology (EAU) represents more than 16,000 urology professionals across Europe and worldwide. Its mission is to raise the level of urological care in Europe. The EAU Annual Congress is the second largest urological congress in the world. Education and postgraduate training are essential tasks of the EAU and aims at promoting quality urological education across Europe and worldwide. Providing effective communication links to promote and disseminate scientific results and information amongst European urologists through e.g. European Urology and European Urology Today remains vital.

Psychologists Suggest Ways To Include The Aging Population In The Technology Revolution

09 nov 2009--Technology is no longer what it used to be: Computers have replaced typewriters and landlines are in rapid decline. Technological advances are being made every day, making many of our lives easier and allowing information to be more accessible and available. However for some people, such as the aging population, technological progress can in fact be more limiting.

Psychologists Neil Charness and Walter R. Boot from Florida State University have outlined these limitations and suggested improvements in a recent paper published in Current Directions in Psychological Science, a journal of the Association for Psychological Science. They claim the key to including the aging population in information technology is to adopt design principles that are age sensitive.

According to the researchers, there are several age-related changes that affect technology use in older adults, including difficulties with vision, audition, motor control and cognition.

Specifically, older adults experience reduced visual acuity, color perception and susceptibility to glare. They also encounter a greater difficulty hearing high-pitched sounds and perceive a greater interference from background noises. As for motor skills, ailments such as arthritis can limit a person's use of technology as well. Aging is also associated with a general slowing of cognitive processes, decreased memory capacity and attentional control, and difficulties with goal maintenance. It also takes older adults twice as long to learn new information compared to younger adults.

"These changes in function can slow performance and result in a greater number of errors as older adults interact with technology that was not designed with their capabilities in mind," explained the authors. The psychologists suggest web designers should avoid backgrounds that create low contrast for text, use larger fonts, minimize scrolling and provide navigation aids and instructional support. They also recommend designers undergo training that takes into account age-related perceptual and cognitive changes.

The authors explain that these changes will alleviate some of the stress of learning and using new technologies, but it will not eliminate difficulties all-together: "It is reasonable to assume that technology will continue to advance rapidly," they concluded. "Also, perceptual, cognitive and psychomotor declines will continue to occur with aging."

So while changes in web design and development will dramatically improve usability for older adults, there will always be hurdles to overcome alongside emerging technologies. But, as the researchers explain, there is hope that some technological advances, such as videogames designed to sharpen cognitive abilities, may ultimately be able to boost technological abilities in the aging population.

Source: Katie Kline
Association for Psychological Science

Researchers Say Healthy Diet Protects Against Depression In Middle Age

09 nov 2009--A new study led by researchers in the UK found that an overall healthy "whole food" diet comprising a high proportion of fruits, vegetables and fish, protected middle aged people against depression compared to a processed food diet containing a high proportion of high fat dairy food, processed meat, fried food, refined grains and sugar-laden desserts.

The study was the work of researchers based at the Department of Epidemiology and Public Health, University College London (UCL), UK and the Institut National de la Santé et de la Recherche Médicale (INSERM), University of Montpellier, France, and is published in the November issue of the The British Journal of Psychiatry which is available online.

In their background information the authors explained that much research on diet and depression tends to focus on individual nutrients so they thought they would look at links between overall dietary patterns and depression.

For the study they looked at data covering 3,486 participants of average age 57 years (nearly three quarters were men) who were part of the Whitehall II study.

The Whitehall II study was set up by co-author and UCL Professor Sir Michael Marmot to investigate links between disease and social class, psychosocial factors and life style. It began by looking at the health of working people, and is now also looking to answer questions about how previous and current circumstances affect health and quality of life in an ageing group of participants.

The data allowed the researchers to identify two dietary patters: a whole food diet and a processed food diet. The whole food diet comprised mainly fresh fruits and vegetables and fish, while the processed diet comprised mainly sweetened desserts, fried foods, high fat dairy foods, processed meat and refined grains.

To assess depression, the researchers used self-reported data that had been gathered five years after the dietary data using the CES-D scale.

CES-D, short for Center for Epidemiologic Studies - Depression scale, is a commonly used self-report questionnaire for assessing depression. It asks a series of multiple choice questions about how the participant has been feeling over the past week, covering topics such as concentration, loss of appetite, worry, how well they have been able to shake off depressive moods, quality of sleep, feelings of loneliness, self-worth, energy levels, and so on.

When they analysed the results and ruled out potential confounders such as age, gender, education, smoking, exercise, and chronic diseases, the researchers found that:

• Participants in the top 33 per cent (top tertile) of the whole food diet pattern, ie whose diet most closely matched the whole food diet, had a 26 per cent lower risk of receiving a CES-D depression assessment five years later (odds ratio 0.74, with 95 per cent probability of this being in the range 0.56 to 0.99) compared to the bottom 33 per cent (bottom tertile), ie whose diet least closely matched the whole food diet.


• In contrast, participants whose diet was high in processed foods had a 58 per cent higher risk of receiving a CES-D depression rating five years later.

The researchers concluded that:

"In middle-aged participants, a processed food dietary pattern is a risk factor for CES-D depression 5 years later, whereas a whole food pattern is protective."

According to BBC News, co-author Dr Archana Singh-Manoux, who works at UCL and INSERM, suggested there was a possibility that the finding could be explained by a lifestyle factor they had not accounted for.

In other words the study does not prove that a processed food diet causes depression: it could be that people destined to become depressed become inclined to eat more processed foods, that there is a yet undiscovered factor behind both.

However, when results as strong as these emerge, and a consistent pattern linking diet and depression is found by several studies, it would tend to suggest that a healthy diet does protect against mental ill health.

The Chief Executive of the UK-based Mental Health Foundation, Dr Andrew McCulloch told the BBC that:

"This study adds to an existing body of solid research that shows the strong links between what we eat and our mental health."

He said major studies like this were crucial in helping us understand more about how diet contributes to mental illness. He said people in the UK were increasingly adopting unhealthy diets, and eating less nutritious and fresh food and more saturated fats and sugars.

"Dietary pattern and depressive symptoms in middle age."
Tasnime N. Akbaraly, Eric J. Brunner, Jane E. Ferrie, Michael G. Marmot, Mika Kivimaki, and Archana Singh-Manoux.
The British Journal of Psychiatry, Nov 2009; 195: 408 - 413.
doi: 10.1192/bjp.bp.108.058925

Postmenopausal women with higher testosterone levels

Chevy Chase, MD, 08 nov 2009— Postmenopausal women who have higher testosterone levels may be at greater risk of heart disease, insulin resistance and the metabolic syndrome compared to women with lower testosterone levels, according to a new study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM). This new information is an important step, say researchers, in understanding the role that hormones play in women's health.

"For many years, androgens like testosterone were thought to play a significant role in men only and to be largely irrelevant in women," said Anne Cappola, MD, of the University of Pennsylvania School of Medicine in Philadelphia. "It is now largely accepted that premenopausal women with polycystic ovary syndrome, a condition in which androgens are elevated, have increased health risks. However, the clinical relevance of testosterone in women over the age of 65 had remained uncertain until this recent study."

In this study, researchers measured levels of testosterone in 344 women, aged 65-98 years. They found that women with the highest testosterone levels — in the top 25 percent of this study group— were three times as likely to have coronary heart disease compared to women with lower testosterone levels. These women were also three times as likely to have a group of metabolic risk factors called the metabolic syndrome compared to women with lower testosterone levels.

The connection between higher levels of testosterone and these health risks may be explained by the researcher's finding of a greater degree of insulin resistance in women with the highest testosterone levels. Insulin resistance is a metabolic disturbance in which the body does not use insulin efficiently and is itself a risk factor for the metabolic syndrome and cardiovascular disease.

"Because of the observational aspect of this study, we cannot discern if testosterone is a marker or mediator of cardiovascular disease in this population," said Cappola. "Further studies are needed to determine if a causal relationship exists between testosterone and insulin resistance and to provide more insight into the role testosterone plays in the pathogenesis of cardiovascular disease in women."

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Other researchers working on the study include Shrita Patel, Sarah Ratcliffe, Muredach Reilly and Rachel Weinstein of the University of Pennsylvania in Philadelphia; Shalender Bhasin of Boston University in Massachusetts; Marc Blackman of the Veterans Affairs Medical Center in Washington, D.C.; Jane Cauley and Kim Sutton-Tyrrell of the University of Pittsburgh in Pennsylvania; and Linda Fried of Columbia University in New York, N.Y.

The article, "Higher Testosterone Levels Are Associated with Insulin Resistance, Metabolic Syndrome, and Cardiovascular Disease in Older Women," will appear in the December 2009 issue of JCEM.

ASN: Sodium, Sweeteners and Fructose Raise Health Risks

Salt, artificial sweeteners increase kidney decline, while fructose increases blood pressure risk

08 nov 2009-- Excessive consumption of sodium and artificial sweeteners increases the risk of declining kidney function, while excess fructose consumption increases the risk of high blood pressure, according to a study presented at the American Society of Nephrology's 42nd Annual Meeting and Scientific Exposition, held from Oct. 27 to Nov. 1 in San Diego.

In separate studies, Julie Lin, M.D., and Gary Curhan, M.D., of Brigham and Women's Hospital in Boston, and colleagues examined the effects of sodium and artificial sweeteners on kidney function among more than 3,000 women in the Nurses' Health Study. Higher dietary sodium intake was found to be associated with a greater kidney function decline in women with well-preserved kidneys, while the odds for kidney decline doubled for women consuming two or more daily servings of artificially sweetened soda.

In a third study, Diana Jalal, M.D., of the University of Colorado Denver Health Sciences Center, and colleagues administered a dietary questionnaire to 4,528 adults without hypertension and calculated fructose intake based on the amounts of fruit juice, soft drink, candy and baked goods consumption reported. Subjects who ate or drank more than 74 grams per day of fructose had a 28 percent increased risk for blood pressure of 135/85 mm Hg, a 36 percent increased risk for 140/90 mm Hg, and an 87 percent increased risk for blood pressure levels of 160/100 mm Hg.

"While more study is needed, our research suggests that higher sodium and artificially sweetened soda intake are associated with greater rate of decline in kidney function," Lin said in a statement.

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Perioperative Beta-Blocker Therapy Guidelines Updated

Treatment initiation requires careful consideration of risks and benefits to patient

04 nov 2009-- The American College of Cardiology Foundation/American Heart Association (ACCF/AHA) recommends perioperative beta-blocker use dependent on careful consideration of the benefits and risks to an individual patient, according to an update of the 2007 guidelines outlining cardiovascular evaluation and care for non-cardiac surgery published online Nov. 2 in the Journal of the American College of Cardiology.

The authors assessed the prophylactic use of perioperative beta blockers in reducing cardiac risk based on consensus opinion after review of late-breaking and new data, with implications in the clinical practice setting.

The authors discussed the 2008 PeriOperative ISchemic Evaluation (POISE) trial results, which showed more deaths in those receiving metoprolol than placebo, with sepsis or infection and stroke more common in the treatment group. The authors suggest ongoing reexamination of the need for and contraindications to beta blockers following surgery. In addition, the authors changed from Class I to Class IIa their advice for beta blockers for patients undergoing vascular surgery at high cardiac risk due to the finding of cardiac ischemia during preoperative testing. Overall, perioperative beta-blocker initiation should take into account careful consideration of the risks and benefits to patients.

"In light of the POISE results, routine administration of perioperative beta blockers, particularly in higher fixed-dose regimens begun on the day of surgery, cannot be advocated. Ongoing and future studies in this area should continue to address limitations in our evidence base on this subject and provide further guidance regarding this important topic," the authors write.

Several authors and reviewers reported financial relationships with pharmaceutical companies and other entities.

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Low cholesterol may be sign of undiagnosed cancer

04 nov 2009– Low total cholesterol may be a sign of cancer rather than a cause, as some researchers have suggested, and men who have low cholesterol actually have a lower risk of developing high-risk prostate cancer, two teams reported on Tuesday.

Both studies, reported in the journal Cancer Epidemiology, Biomarkers & Prevention, shed new light on the role of cholesterol and cancer.

For years, researchers had noticed that people who have lower total cholesterol -- a combination of both low-density lipoprotein or LDL, the "bad" kind, and high-density lipoprotein or HDL, the "good" kind -- appeared more likely to have certain types of cancers than other people.

That was worrisome because having low cholesterol, and particularly low levels of "bad" LDL cholesterol, has been shown to protect against heart attacks and strokes.

"Our study affirms that lower total cholesterol may be caused by undiagnosed cancer," Dr. Demetrius Albanes, a senior investigator at the National Cancer Institute, part of the National Institutes of Health, said in a statement.

"In terms of a public health message, we found that higher levels of 'good' cholesterol seem to be protective for all cancers," he said.

The 18-year study of nearly 30,000 Finnish male smokers is the largest and longest of its kind. During that period, 7,545 men developed cancer.

The men with lower total cholesterol levels -- below 230 milligrams/deciliter -- had an 18 percent higher risk of cancer overall -- just as in earlier studies.

But, when they excluded cancers that occurred in the first nine years of the study, this risk disappears.

"This finding supports the idea that the lower serum total cholesterol level we detected as a possible cancer risk factor may actually have been the result of undiagnosed cancers," Albanes told reporters in a telephone briefing.

They also found men who had higher levels of HDL or "good" cholesterol (above 40 milligrams/deciliter) had a 14 percent lower risk of cancer even after excluding nine years of early cases.

MORE STUDIES NEEDED

Albanes said the notion that high levels of HDL may protect against cancer is new and needs to be confirmed in other studies, particularly among women.

"The results should help dispel any lingering concerns anyone might have that having low cholesterol could cause cancer," Eric Jacobs of the American Cancer Society told reporters.

A companion study of more than 5,000 U.S. men by Elizabeth Platz of Johns Hopkins University in Baltimore and colleagues found a link between low cholesterol and a lower risk of high-grade prostate cancer among 5,586 men over 55.

They found that if men had total cholesterol of less than 200 milligrams/deciliter, they had a nearly 60 percent lower risk of developing high grade prostate cancer, the riskiest kind.

It is not clear whether taking cholesterol-lowering statin drugs might help men with prostate cancer. That would need to be studied, Platz said.

Study shows that sleep disturbances improve after retirement

This study is the first to examine the trajectories in sleep disturbances before and after retirement over an extended time window

WESTCHESTER, Ill., 03 nov 2009 - A study in the Nov.1 issue of the journal Sleep shows that retirement is followed by a sharp decrease in the prevalence of sleep disturbances. Findings suggest that this general improvement in sleep is likely to result from the removal of work-related demands and stress rather than from actual health benefits of retirement.

Results show that the odds of having disturbed sleep in the seven years after retirement were 26 percent lower (adjusted odds ratio of 0.74) than in the seven years before retiring. Sleep disturbance prevalence rates among 14,714 participants fell from 24.2 percent in the last year before retirement to 17.8 percent in the first year after retiring. The greatest reduction in sleep disturbances was reported by participants with depression or mental fatigue prior to retirement. The postretirement improvement in sleep also was more pronounced in men, management-level workers, employees who reported high psychological job demands, and people who occasionally or consistently worked night shifts.

Lead author Jussi Vahtera, professor in the department of public health at the University of Turku in Finland, noted that the participants enjoyed employment benefits rarely seen today, including guaranteed job stability, a statutory retirement age between 55 and 60 years, and a company-paid pension that was 80 percent of their salary.

"We believe these findings are largely applicable in situations where financial incentives not to retire are relatively weak," said Vahtera. "In countries and positions where there is no proper pension level to guarantee financial security beyond working age, however, retirement may be followed by severe stress disturbing sleep even more than before retirement."

The study involved employees from the French national gas and electricity company, Electricité de France-Gaz de France, who retired between 1990 and 2006 at a mean age of 55 years. The study includes data from 11,581 male and 3,133 female workers who reported sleep disturbances at least once before and once after the year of retirement. Thirty-five percent of participants had worked night shifts, and 17 percent reported having depression.

Annual survey measurements ranging from seven years before to seven years after retirement (with a mean of 12 measurements) were collected throughout the study period. Participants completed questionnaires concerning health, lifestyle, individual, familial, social and occupational factors. The presence of sleep disturbances was indicated by an affirmative response to a single question from a systematic checklist of more than 50 medical conditions experienced during the previous 12 months. Information concerning occupational and health data also was collected from the company.

Results also show that there is a slowly increasing prevalence of sleep disturbances with increasing age, which can be observed both before and after retirement. From the first to the seventh year after retirement, the prevalence of sleep disturbances increased from 17.8 percent to 19.7 percent but remained significantly lower than at any time point prior to retirement.

The only exception to the general improvement in sleep after retirement was related to the four percent of participants whose retirement was based on health reasons. People who retired early because of a long-standing illness or disability had a 46 percent increased risk of sleep disturbances (adjusted odds ratio of 1.46) after retiring.

The authors conclude that in the present time when people are expected to live many years beyond the traditional age of retirement, consideration should be given to the restructuring of working life to enable older workers to remain economically active without compromising their future health.

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Sleep is the official journal of the Associated Professional Sleep Societies, LLC (APSS), a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society. The APSS publishes original findings in areas pertaining to sleep and circadian rhythms. Sleep, a peer-reviewed scientific and medical journal, publishes 12 regular issues and 1 issue comprised of the abstracts presented at the SLEEP Meeting of the APS

Cataract surgery helps AMD patients; steroid improves DME; online eye health forum

Research highlights, 2009 Ophthalmology journal

SAN FRANCISCO, CA, 03 nov 2009--- This month's Ophthalmology, the journal of the American Academy of Ophthalmology (Academy) reports on a national study that finds cataract surgery is likely to benefit patients with age-related macular degeneration (AMD) at all stages of the disease, on a clinical trial showing that the steroid triamcinolone may be effective in advanced diabetic macular edema (DME) patients when standard treatment fails, and on the public's use of two Academy-sponsored online eye health forums.

Multicenter Study Finds AMD Patients Benefit from Cataract Surgery

Cataract surgery improved vision in patients with any stage–from mild to advanced– AMD in the first study to include an adequate number of advanced AMD patients. Data was obtained from the multicenter, prospective Age-Related Eye Disease Study (AREDS), funded by the National Eye Institute (NEI), which was organized primarily to evaluate the effects of high-dose vitamin and mineral supplements on cataract and AMD. As the American population ages AMD prevalence is expected to rise, and many patients will concurrently develop cataract; both diseases can cause blindness if untreated.

"Earlier epidemiology had suggested cataract surgery might worsen AMD, so the data from the AREDS cohort study were evaluated to answer this important question," said Emily Y. Chew, MD, who led the study for NEI.

The cohort, comprising 1,939 eyes (1,244 patients) with various stages of AMD, was evaluated for visual acuity (sharpness) after cataract surgery. On average, patients with AMD, ranging from mild to advanced, gained visual acuity after cataract surgery; the best gains were in patients with vision worse than20/40 before surgery. No difference in improvement was noted between patients with "wet" (neovascular) or "dry" (central geographic atrophy) AMD. About one year later vision gains remained statistically significant in the 865 eyes available for follow-up. Results for the primary focus of AREDS, regarding the effect of nutritional supplements, showed that high doses of vitamins C, E and beta-carotene did not affect the development or progression of cataract, but this vitamin combination plus zinc did reduce the risk of progression to advanced AMD by 25 percent in the five years of the study.

Steroids Helps Diabetic Macular Edema Patients When Other Treatment Fails

A five-year study based at the University of Sydney, Australia, found that intravitreal triamcinolone (IVTA) effectively improved vision in patients with DME, a form of diabetic retinopathy, whose eyes had continued to deteriorate despite receiving standard laser treatment.

"The majority of patients who improved with IVTA after initial treatment continued to enjoy better vision at the five year conclusion of our clinical trial, and no new safety concerns were found in these patients," said lead researcher Mark Gillies, PhD. "We believe treatment with IVTA may be considered in carefully selected advanced DME patients when standard treatment has failed to improve vision," he added.

In the first three months after treatment, the patients initially treated with both IVTA and laser showed significantly better gains in vision than control group patients, who were treated with laser only. After two years, patients in the original control group were also treated with IVTA. The beneficial effects persisted in most IVTA-treated patients throughout the five-year study; however, 80 percent of patients in the initial IVTA group developed elevated intraocular pressure and 56 percent of them required glaucoma therapy. Also, two-thirds of all patients required cataract surgery during the study period. Similar outcomes have been noted in other studies of steroid-based treatment and thus were not considered new safety concerns by Dr. Gillies' group.

What Do People Ask About in Online Eye Health Forums?

To identify the topics of highest interest to people who access eye health information on line, John C. Hagan, MD, and colleagues analyzed 4,485 questions over six months (September 1, 2008 to March 1, 2009) posted on the "Ask a Doctor: Ophthalmology" and "Eye Care Community" forums sponsored by the Academy on MedHelp (www.medhelp.org ), one of the 10 largest health information websites. Dr. Hagan and three other ophthalmologists provide free, timely advice to a large and growing number of people with eye health and vision problems through these forums. Serious problems, such as life-threatening retinoblastomas in babies, have been caught and treated in time thanks to these forums, as have thousands of other eye and vision problems.

Concerns related to the retina topped the list at nearly 20 percent of all questions; many people asked about "flashes," "floaters," or retinal detachment. About 19 percent of questions were related to the cornea, the clear outer surface of the eye that helps focus light to make vision possible. Cataract and implanted lens questions were next in prevalence, followed by brain-eye problems (neuro-ophthalmology), children's eye alignment (strabismus), eye cancers, and general discomfort or blurry vision. Two-to-three percent of questions related to each of three vision correction topics: refractive surgery (LASIK and others), eyeglasses, or contact lenses. A smaller number were related to eye care products or medical insurance. The analysis also found many people submit postings to express their gratitude for the medical advice provided.

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Eds: Full texts of the studies are available from the Academy's media relations department.

About the American Academy of Ophthalmology

The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons—Eye M.D.s—with more than 27,000 members worldwide. Eye health care is provided by the three "O's" – opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at www.aao.org.

Surgery Not Found to Affect Cognitive Function in Elderly

Non-cardiac surgery, illness not linked to cognitive decline even in those with mild dementia

02 nov 2009-- Non-cardiac surgery and major illness have no long-term effect on cognitive function in the elderly, including those with mild dementia, according to a study in the November issue of Anesthesiology.

Michael S. Avidan, from Washington University in St. Louis, and colleagues tracked cognitive function before and after non-cardiac surgery, illness, or neither in 575 elderly subjects (214 non-demented and 361 with mild dementia at enrollment).

The researchers found that cognitive trajectories remained similar among patients after surgery, illness or neither, although cognitive function declined more rapidly among demented patients. Although nearly a quarter (23 percent) of non-demented patients progressed to a clinical dementia rating greater than zero, this was not associated with surgery or illness.

"The study did not detect long-term cognitive decline independently attributable to surgery or illness, nor were these events associated with accelerated progression to dementia," Avidan and colleagues conclude. "The decision to proceed with surgery in elderly people, including those with early Alzheimer disease, may be made without factoring in the specter of persistent cognitive deterioration."

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Editorial

The Power Of Doctors Makes Elderly Patients Passive

02 nov 2009--Elderly patients are often critical about consultations with their doctor. Hierarchical structures, time pressure and traditions in the health care sector make these patients and their relatives passive when facing the doctor and his or her position of power. This is shown in a thesis from the Sahlgrenska Academy, University of Gothenburg, Sweden.

The study is based on interviews with 20 elderly patients and their relatives in Gothenburg, Sweden, and about an equal number of doctors.

'We cannot disregard that the ability of doctors to communicate with elderly patients and their relatives could be improved, and that this shortcoming may explain why this group of patients feel insecure in meeting with the doctor. They don't feel at home in the health care system and sometimes have problems understanding the doctor,' says Sandra Pennbrant, nurse and the author of the thesis.

A good relationship between the doctor and the patient leads to reduced apprehension and increased faith in the health care system. This kind of relationship requires, among other things, that the doctor and the patient discuss the situation and that the doctor listens to what the patient has to say before deciding on a treatment plan.

'Elderly patients and their relatives tend to have a critical view of meetings with the doctor. Doctors and patients have the same understanding of how good relations can be created, but it seems that doctors have a hard time accomplishing it in real life,' says Pennbrant.

The interviewed doctors feel it is difficult to create good relationships when meeting with elderly patients and that this is mainly because the patient often only stays in hospital for a short time.

Pennbrant concludes that the health care sector needs to become a learning organisation where the medical personnel are trained to prevent misunderstandings in their meeting with elderly patients and their relatives.

'Doctors need to learn to acknowledge the questions elderly patients may have and consider their medical conditions and personalities in communication and when building relations. Relatives should also participate in this meeting, so that they feel their work is supported and appreciated,' says Pennbrant.

Thesis for the Degree of Doctor of Philosophy at the Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, publicly defended 2009-10-23
Title of the thesis: How elderly patients, relatives and doctors experience their meeting - A sociocultural study in a hospital setting
Link to thesis: http://hdl.handle.net/2077/21198

Source:
Elin Lindström Claessen
University of Gothenburg

Does Diabetes Slow Alzheimer's?

01 nov 2009-- A French study finding that people with Alzheimer's disease and diabetes have less memory loss than those without diabetes should be regarded with caution, American experts say.

"It's not clear from this study and others what the relationship is," said William Thies, chief medical and scientific officer of the Alzheimer's Association.

What is clear, Thies said, is that having diabetes increases the risk of developing Alzheimer's disease -- a relationship acknowledged in the first sentence of a report on the French study in the Oct. 27 issue of Neurology.

But there haven't been too many studies looking at the effect of diabetes on the progression of Alzheimer's, said the report by researchers at INSERM, the French National Institute for Health and Medical Research in Toulouse.

So, they followed 608 people with mild to moderate Alzheimer's disease for four years, testing their memory and thinking skills twice a year.

The 63 participants with diabetes -- 10.4 percent of the total -- started with the same average score of 20 on the test of thinking ability. There was an average overall decline of 1.24 points on that test every six months. But the decline in thinking ability scores was 0.38 points greater every six months for those without diabetes.

Previous studies of the relationship between diabetes and loss of cognitive function have had mixed results, Thies said. "Some showed a faster decline, some showed a slower decline," he said. "It is still a confused area."

One factor that has a strong influence on the results is the stage of disease in the people being studied, Thies said. "You know that early on, the disease does not progress quickly," he said. "So, if you study people in the early stage or the late stage, that can overwhelm the results."

A close look showed that the diabetic participants in the French study had Alzheimer's disease for a shorter period of time than the non-diabetics, said Dr. Robert Friedland, chair of neurology at the University of Louisville.

And the differences seen in the study "are very minimally significant, less than a point on a 30-point scale," Friedland said. "The difference in many of the mental state examination scores was very small. It was statistically significant, but clinically meaningless."

He ticked off several reasons why a difference was found. The medications taken for diabetes to help control blood sugar level could have a beneficial effect on the brain, Friedland said. "Also, patients with diabetes have more vascular disease in the heart as well as the retina, and some of their impairment might be due to that, so it was progressing more slowly," he said.

There was also a possibility of misdiagnosis, since no autopsies were done in the study, Friedland said.

"The important message is that there are potentially modifiable risk factors for Alzheimer's disease, some of which are also risk factors for diabetes -- lack of physical activity, obesity," he said.

For Thies, the lesson of the study is that "to understand relationships like this, you need more long-term cohort studies like this one. We need more studies, and the real barrier is money."

More information

The latest information on Alzheimer's disease is available from the Alzheimer's Association.

Anemia Drug May Raise Stroke Risk in Kidney Patients

01 nov 2009-- A drug designed to fight anemia appears to double the risk of stroke in patients with diabetes and kidney disease without substantially improving their quality of life, a new study finds.

Darbepoetin alfa, marketed as Aranesp and known as an erythropoiesis-stimulating agent (ESA), is often prescribed for diabetic patients with chronic kidney disease and mild anemia.

"The benefits we assumed we would have by treating anemia were less striking and the risks were more striking," said lead researcher Dr. Marc A. Pfeffer, a professor of medicine in the cardiovascular division of Brigham and Women's Hospital in Boston.

"This provides new data for doctors and patients to make their own risk-benefit assessment," he said. "There was a perception that treating anemia would make people feel so much better that we'll take risks, but the benefit in quality of life was not as great as we thought, and there was a clear doubling of your risk for a stroke."

The report was published in the Oct. 30 online edition of the New England Journal of Medicine to coincide with its scheduled presentation at the annual meeting of the American Society of Nephrology in San Diego.

For the study, Pfeffer's team randomly assigned more than 4,000 patients with diabetes, chronic kidney disease and anemia to receive Aranesp or placebo. During the study, 632 patients receiving Aranesp died or suffered a cardiovascular event, compared to 602 of the patients receiving placebo.

As well, 101 patients taking Aranesp had a fatal or non-fatal stroke compared with 53 of the placebo patients, the researchers found. In addition, patients taking Aranesp reported only a modest improvement in their fatigue, the researchers noted.

In earlier studies, Aranesp and a similar drug, epoetin alfa, marketed as Procrit or Epogen, were linked to increased risk of death in cancer and stroke patients.

Pfeffer believes that people with more severe kidney disease, such as those on dialysis, might still find Aranesp beneficial and the risk acceptable.

"People on dialysis generally feel even worse and generally have even more severe anemia, and this class of therapy has been very helpful to them," he said.

Because the drug was beneficial to these patients, doctors assumed it would help less severely anemic patients, Pfeffer said.

"But this use of ESAs exceeded the data," he said. "Now we have the data, and we will revisit how the drug is used now."

Dr. Phillip Marsden, a professor of medicine at the University of Toronto and author of an accompanying journal editorial, said these findings mean that doctors and patients will have to discuss whether or not to start the medication.

"For most of these patients, the modest improvement in quality of life will not be enough to subject themselves to the increased risk of stroke and death," he said.

ESAs have been used for two decades, Marsden noted. "It is a bit shocking that it took us 20 years to address whether or not these drugs were safe -- and now we know more."

Dr. Ajay Singh, clinical chief of the renal division and director of dialysis at Brigham and Women's Hospital, said this "landmark study" raises the fundamental question of whether epoetin or darbepoetin should routinely be used in treating anemia of chronic kidney disease.

"Earlier studies raised the specter of increased risk with ESA treatment. This study definitively confirms that there is meaningful risk with routine use of ESAs," said Singh, also an associate professor of medicine at Harvard Medical School.

"In my own practice, I will be cautious in using ESAs for most patients with chronic kidney disease, balancing risk with benefits and reserving treatment largely for patients who need frequent blood transfusions or who are candidates for a kidney transplant," he said.

More information

For more information on ESAs, visit the U.S. Food and Drug Administration.