Statins recommended for primary prevention of cardiovascular disease in adults

The U.S. Preventive Services Task Force (USPSTF) concludes that people aged 40 to 75 years at high risk for cardiovascular disease (CVD) should receive statins. This finding forms the basis of a final recommendation statement published in the Aug. 23/30 issue of the Journal of the American Medical Association.

03 sept 2022--Roger Chou, M.D., from the Oregon Health & Science University in Portland, and colleagues updated the 2016 review on statins for primary prevention of CVD. Data were included from 26 studies. The researchers found that statins were significantly associated with a reduced risk for all-cause mortality, stroke, myocardial infarction, and composite cardiovascular outcomes (risk ratios, 0.92, 0.78, 0.67, and 0.72, respectively); the association with cardiovascular mortality was not statistically significant. In groups defined by demographic and clinical characteristics, relative benefits were consistent, but data were limited for those older than 75 years.

Based on these findings, the USPSTF recommends that statins should be prescribed for primary prevention of CVD in adults aged 40 to 75 years with no CVD history and with one or more CVD risk factors and an estimated 10-year CVD event risk of 10 percent or greater (B recommendation). For adults aged 40 to 75 years with no history of CVD and who have one or more of these CVD risk factors and an estimated 10-year CVD event risk of 7.5 to <10 percent, statins may be selectively offered (C recommendation). For those aged 76 years or older with no history of CVD, the evidence is insufficient to determine the balance of benefits and harms of statin use ( I statement).

"Statins effectively and safely prevent first heart attacks and strokes for some people," USPSTF member John Wong, M.D., said in a statement. "Whether someone should start taking a statin depends on their age and their risk for having a first heart attack or stroke."

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More information: Evidence Report
Final Recommendation Statement
Editorial 1
Editorial 2
Editorial 3
Editorial 4

Journal information: Journal of the American Medical Association 

 

USPSTF updates guidance on statins for primary prevention of CVD

The U.S. Preventive Services Task Force (USPSTF) recommends statins for the primary prevention of cardiovascular disease (CVD) for adults aged 40 to 75 years who have cardiovascular risk factors, with the strength of recommendation varying with cardiovascular event risk. These recommendations form the basis of a draft recommendation statement published Feb. 22 by the USPSTF.

09 mar 2022--Roger Chou, M.D., from the Oregon Health & Science University in Portland, and colleagues updated the 2016 review on statins for primary prevention in adults with cardiovascular risk. The researchers found that statin therapy was associated with a reduced risk for all-cause mortality, stroke, myocardial infarction, and composite cardiovascular outcomes (risk ratios, 0.92, 0.78, 0.67, and 0.72, respectively). The estimate for cardiovascular mortality was not statistically significant. The relative benefits were consistent in subgroups, including those with cardiovascular risk factors without marked dyslipidemia. For older persons, data remained sparse and imprecise. Statin therapy was not significantly associated with increased risks for serious adverse events, myalgia, liver-related harms, or diabetes.

Based on these findings, the USPSTF recommends statins for primary prevention of CVD for adults aged 40 to 75 years with one or more CVD risk factors and with an estimated 10-year risk for a cardiovascular event of 10% or greater (B recommendation). For adults aged 40 to 75 years with one or more CVD risk factors and with an estimated 10-year risk for a cardiovascular event of 7.5 to 10%, the USPSTF recommends that clinicians selectively offer statins for primary prevention (C recommendation). The evidence is currently insufficient for assessing the balance of benefits and harms of statin initiation for primary prevention of CVD and mortality in adults aged 76 years or older (I statement).

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More information: The draft evidence review and recommendation statement are available for public comment from Feb. 22 to March 21, 2022.

Draft Evidence Review

Draft Recommendation Statement

Comment on Recommendation Statement

Study does not support widespread use of statins in healthy older people to prevent heart disease

3D Model of the heart by Dr. Matthew Bramlet. Credit: NIH

Statins are not associated with a reduction in cardiovascular disease (conditions affecting the heart and blood vessels) or death in healthy people aged over 75, finds a study published by The BMJ today.
However, in those with type 2 diabetes, statins were related to a reduction in cardiovascular disease and death from any cause up to the age of 85 years.

09 sept 2018--The results of the study, led by the University Institute for Primary Care Research Jordi Gol (IDIAPJGol) and Girona Biomedical Research Institute (IDIBGI), do not support the widespread use of statins in old and very old people, but they do support treatment in selected people, such as those aged 75-84 years with type 2 diabetes, say the researchers.
Cardiovascular disease is the leading cause of death globally, especially for those aged 75 and over. Statin prescriptions to elderly patients have increased in recent decades, and trial evidence supports statin treatment for people aged 75 years or older with existing heart disease(known as secondary prevention).
But evidence on the effects of statins for older people without heart disease (known as primary prevention) is lacking, particularly in those aged 85 years or older and those with diabetes.
So researchers based in Spain set out to assess whether statin treatment is associated with a reduction in cardiovascular disease and death in old (75-84 years) and very old (85 years and over) adults with and without type 2 diabetes.
Using data from the Catalan primary care system database (SIDIAP), they identified 46,864 people aged 75 years or more with no history ofcardiovascular disease between 2006 and 2015.
Participants were grouped into those with and without type 2 diabetes and as statin non-users or new users (anyone starting statins for the first time during the study enrollment period).
Primary care and hospital records were then used to track cases of CVD (including coronary heart disease, angina, heart attack and stroke) and death from any cause (all cause mortality) over an average of 5.6 years.
In participants without diabetes, statin treatment was not associated with a reduction in CVD or all cause mortality in both old and very old age groups, even though the risk of CVD in both groups was higher than the risk thresholds proposed for statin use in guidelines.
In participants with diabetes, however, statins were associated with significantly reduced levels of CVD (24%) and all cause mortality (16%) in those aged 75-84 years. But this protective effect declined after age 85 and disappeared by age 90.
This was an observational study, so no firm conclusions can be drawn about cause and effect, and the authors cannot not rule out the possibility that some of their results may be due to unmeasured (confounding) factors.
But they point out that this was a high quality study with a large sample size, reflecting real life clinical conditions.
A such, they conclude that their results do not support the widespread use of statins in old and very old populations, but they do support treatment in those with type 2 diabetes younger than 85 years.
In a linked editorial, Aidan Ryan at University Hospital Southampton and colleagues, say the biggest challenge for clinicians is how to stratify risk among those aged more than 75 to inform shared decision making.
These observational findings should be tested further in randomised trials, they write. In the meantime, they say "patient preference remains the guiding principle while we wait for better evidence."

More information: Statins for primary prevention of cardiovascular events and mortality in old and very old adults: retrospective cohort study, www.bmj.com/content/362/bmj.k3359

Editorial: Primary prevention with statins for older adults, www.bmj.com/content/362/bmj.k3695


Provided by British Medical Journal

Statins' benefits outweigh side-effects: science review

The heart-protecting benefits of anti-cholesterol statins far outnumber the side-effects, a scientific review said Friday blaming shoddy research for scaring people and putting lives at risk.
Much of the evidence for statins' bad rap came from trials whose very design did not allow them to draw any conclusions, said the authors of the review seeking to "help doctors, patients and the public make informed decisions."

10 sept 2016--Their own analysis, the team wrote, showed that statins prevented many more heart attacks and strokes than they caused muscle problems or diabetes.
"We've had an underestimation of the benefits and a massive overestimation of the harms," said Rory Collins of the University of Oxford's Nuffield Department of Population Health, who co-authored the review in The Lancet.
"Consequently there is a serious cost to public health from making misleading claims about high side-effect rates that inappropriately dissuade people from taking statin therapy despite the proven benefits."
Statins have been used for about 30 years to bring down "bad" LDL cholesterol, which has been linked to a risk for heart and artery disease.
It is prescribed as "secondary prevention" for people already suffering cardiovascular disease, but increasingly also as "primary prevention" for those at high risk due to high blood pressure or diabetes, for example.
As conflicting reports of statins' benefits and harms have hit the headlines in recent years, people prescribed them had stopped taking the drugs.
The new review showed that using statins to lower cholesterol would prevent "major cardiovascular events" in 1,000 out of 10,000 secondary prevention users over five years.
In people who take statins for primary prevention, 500 out of 10,000 would avoid a major event such as heart attack, stroke or coronary bypass, said the authors.

The snag

On the downside, five in 10,000 would develop myopathy—a muscle disease.
Five to ten would have a haemorrhagic stroke, which causes bleeding on the brain, and about 50-100 would develop diabetes.
However, Collins said the other type of stroke, caused by blood clots, was vastly reduce by statins—thus lowering the overall stroke risk.
The team had reviewed data from so-called randomised controlled trials, in which one group of people were given the real drug and another group a dummy "placebo" drug, without knowing who is getting what.
This is the only type of trial, the authors said, which can ascribe an effect to a drug being tested.
However, much of the evidence for statin risks came from "observational studies".
They are not designed to show a cause and effect, yet have ascribed to statins everything from memory loss, cataracts, liver disease, sleep disturbance, aggression, suicidal behaviour and erectile disfunction—none of which were borne out by randomised controlled trials, said the team.
"We hope that the impact of publishing this comprehensive scientific review will be to correct the public record about the safety and efficacy of statins," The Lancet editor Richard Horton told journalists.
A daily 40-milligram statin dose costs about £2 ($2.70, 2.6 euros) per month in Britain, where some two million people are prescribed statins for secondary prevention and four million for primary prevention.
This meant some 80,000 people in Britain alone will be spared a major cardiovascular event, said the reviewers, who received research funding from drug companies but insisted they were independent.
Other experts not involved in the study said it was a good summary of the risks and benefits.
"Statins have been unfairly demonised," Tim Chico, a cardiologist from the University of Sheffield, told the Science Media Centre.
"Statins can cause side effects, but the chance of developing these is low while the effects of suffering the heart attack that a statin might have prevented can be fatal or life-long."

More information: The Lancet, www.thelancet.com/journals/lancet/article/PIIS140-6736(16)31357-5/abstract

Evidence Limited on Statins for Primary Prevention

Statins found to reduce death, cardiac events, but selective and potentially biased reporting occurred

20 jan 2011-- There is not enough evidence to support the widespread use of statins in individuals with no history of cardiovascular disease (CVD), according to a review published in The Cochrane Library.

Fiona Taylor, of the London School of Hygiene and Tropical Medicine, and colleagues reviewed data from 14 trials involving 34,272 patients to assess the effects of statins among individuals with no history of CVD. Outcomes in patients prescribed statins were compared to outcomes in patients given placebos or usual care.

Using combined data from eight trials involving 28,161 patients that provided data on deaths from all causes, the investigators found that statins reduced the risk of dying from nine to eight deaths for every 1,000 people treated with statins each year. In addition, statins reduced fatal and non-fatal CVD events, stroke and revascularization surgery, and blood cholesterol levels. However, the researchers write that their conclusions are limited by unclear, selective, and possibly biased reporting and that patients' individual risk profiles should be carefully considered before statins are prescribed.

"Although reductions in all-cause mortality, composite end points, and revascularisations were found with no excess of adverse events, there was evidence of selective reporting of outcomes, failure to report adverse events, and inclusion of people with CVD. Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk," the authors write.

Abstract

ATS: Meta-Analysis Confirms Statins' Anti-Thrombotic Effect

Research finds statins decrease risk of pulmonary embolism, deep venous thrombosis

31 may 2010-- The preponderance of evidence shows that statins do decrease the risk of venous thromboembolism, according to research presented May 16 at the annual international conference of the American Thoracic Society, held in New Orleans May 14-19, and published in the May issue of American Journal of Respiratory and Critical Care Medicine.

V. Agarwal, of the University of Connecticut Health Center, Hartford, and colleagues conducted a meta-analysis of 10 studies that evaluated the effect of statin drugs on deep vein thrombosis (DVT), pulmonary embolism (PE) or any venous thromboembolism (VTE), defined as DVT and/or PE. Only one randomized trial, JUPITER, met the inclusion criteria.

In JUPITER, the adjusted odds ratio (AOR) for VTE was 0.57; the AORs for DVT only and PE only were 0.45 and 0.77, respectively. Observational studies showed less risk reduction for VTE and DVT, but a larger risk reduction for PE. For all studies combined, the effect of statins was a 32 percent risk reduction for VTE, a 41 percent risk reduction for DVT only, and a 30 percent risk reduction for PE only.

"The totality of clinical study evidence suggests that statins can reduce patients' odds of developing DVT or PE," the authors write.

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Statins May Drain Energy Along with Cholesterol

Compared to placebo, simvastatin and pravastatin associated with decreased levels of energy

15 mar 2009-- Statins effectively reduce low-density lipoprotein (LDL) cholesterol, but they also appear to reduce patients' levels of energy and activity, according to research presented at the American Heart Association's 49th Annual Conference on Cardiovascular Disease Epidemiology and Prevention, held Mar. 10 to 14 in Palm Harbor, Fla.

Beatrice Golomb, M.D., of the University of California San Diego, and colleagues randomly assigned 1,016 adults who were free of diabetes or heart disease but had LDL levels between 115-190mg/dL to receive either simvastatin, pravastatin or placebo for six months. They assessed energy and activity at baseline on scales of 0-10 and again on follow-up, with a score of -2 indicating "much worse" and a score of +2 indicating "much better."

The researchers found that simvastatin was associated with a greater mean LDL reduction than pravastatin (49 mg/dL versus 40 mg/dL). Compared to placebo, however, they found that pravastatin was associated with a significantly higher proportion of patients who rated both their energy and activity levels as "much worse" and that simvastatin was associated with a significantly higher proportion of patients who rated their energy level as "much worse."

"Future studies should extend evaluation to higher statin doses; and include assessment of measured activity," the authors conclude.

Statins lower stroke severity, improve recovery

ROCHESTER, Minn., 01 mar 2009 — Mayo Clinic researchers have shown that patients who were taking statins before a stroke experienced better outcomes and recovery than patients who weren't on the drug — even when their cholesterol levels were ideal. The finding is reported in the current issue of the Journal of Stroke and Cerebrovascular Diseases.

"We were trying to determine if the daily use of statins had more of an impact on stroke patients than simply lowering their "bad" (low-density lipid) cholesterol," explains lead researcher Latha Stead, M.D. "We already knew statin use improved outcomes in general, so we focused on the patients who had optimal LDL levels and found it still had quite significant value."

Statins or reductase inhibitors are enzymes that are widely used to improve cardiovascular health and, more recently, for certain vascular conditions in the brain. One use has been to lower the level of LDL which can contribute to arterial blockages.

Significance of the Research

Previous researchers had shown a lower death rate and improved function in strokes when people had used statins. The Mayo team found that statin used in this cohort also decreased the severity of the strokes and significantly improved overall outcomes. The researchers say this shows benefits far beyond lowering lipid levels. Researchers think the specific benefits may include plaque stabilization and improved cell function in vascular walls, as well as anti-inflammatory and antioxidant factors. More research is needed to pinpoint the specific benefits.

How it was done

Researchers identified 508 patients who were diagnosed with acute ischemic stroke in the emergency department during the 22 months from March 2004 to December 2005. Among that number, 207 had their lipid levels measured within 15 days either side of the stroke incident — and had LDL levels at or below 100 mg/dL, which is considered optimal for healthy individuals. Roughly half the cohort of 207 had been taking statins. Researchers also adjusted for age, gender and stroke severity.

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Others on the research team were Lekshmi Vaidyanathan, M.B.B.S.; Gautam Kumar, M.B.B.S.; M. Fernanda Bellolio, M.D.; Robert Brown, Jr., M.D.; Smitha Suravaram, M.B.B.S.; Sailaja Enduri, M.B.B.S.; Rachel Gilmore, M.B.B.Ch.; and Wyatt Decker, M.D., all of Mayo Clinic.

A Call for Caution in the Rush to Statins

By TARA PARKER-POPE

19 nov 2008--Is it time to put cholesterol-lowering statin drugs in every medicine cabinet?

Judging by recent headlines, you might think so. Last week heart researchers reported that millions of healthy people could benefit from taking statins even if they don’t have high cholesterol.

Although many doctors hailed the study as a major breakthrough, a closer look at the research suggests that statins (like Crestor, from AstraZeneca, and Lipitor, from Pfizer) are far from magic pills. While they clearly save lives in people with a previous heart attack or other serious heart problems, for an otherwise healthy person the potential benefit remains small.

Many doctors who believe in using statins for heart disease say they needn’t be given to healthy patients. Instead, they say, the focus should remain on encouraging healthful behavior and screening for traditional risk factors like high blood pressure and cholesterol.

“Statins have many biological effects that appear to be quite meaningful,” said Dr. Valentin Fuster, director of the heart program at Mount Sinai Medical Center in Manhattan and past president of the American Heart Association. “But I don’t think the answer is a magic drug to prevent disease. The answer is to change behavior.”

Still, the latest study, called Jupiter, is sure to fuel interest in a blood test for something called C-reactive protein, or CRP. The test, which can cost $20 to $50, measures inflammation. Studies have shown that patients with high CRP are at higher risk for heart attack, even if they have normal cholesterol.

The researchers sought out men 50 and older and women 60 and older who had elevated CRP but not high cholesterol. The goal was to determine whether statins could improve their health.

But of nearly 90,000 people who were screened, only 17,802 were selected. That means 80 percent of the recruits were excluded for a variety of reasons — another inflammatory condition like arthritis, medication use, high blood pressure, a history of cancer and so on.

“If you extrapolate that, it means there are not all that many people exactly like those who were studied,” said Dr. Nieca Goldberg, director of the women’s heart program at New York University Langone Medical Center.

“But I can see a lot of people will be wanting a CRP test,” she went on. “My greatest concern is that there will be many people who don’t fit the criteria of the study, but based on this they will get blood tests and statin therapy.”

And because of the way the Jupiter results were reported, many healthy people are likely to get an exaggerated view of statins’ benefits. While the investigators reported an impressive-sounding 50 percent reduction in the risk of serious heart problems among the statin users, in reality everyone in the study had a low risk to begin with.

Only 1.8 percent of the subjects who took a placebo had a major cardiovascular problem during the study period. Among statin users, 0.9 percent did. In other words, the absolute risk of a serious cardiovascular problem (as opposed to the relative risk) was reduced by less than one percentage point.

“Absolute differences in risk are more clinically important than relative reductions in risk in deciding whether to recommend drug therapy,” The New England Journal of Medicine noted in an editorial accompanying a report on the study.

An important indicator of the usefulness of a drug is the “number needed to treat,” a measure of how many people needed to take a pill for just one person to be helped. There is disagreement about what Jupiter showed. The New England Journal editorial concluded that treating 120 people for about two years would help one person. The study authors, using different criteria, came up with a figure of 95.

Some researchers think the number is actually much lower. Extrapolating the data to five years, the study’s authors concluded that just 25 healthy people would need to take a statin to prevent one serious heart problem.

As a result, some doctors say they will start testing for CRP and will offer statin therapy to patients whose levels are high.

“This was definitely a pretty stunning result,” said Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. “I, for one, will be checking CRP in more patients. If it’s elevated, we will be treating them.”

Doctors said one worrisome trend did emerge in the study. In the statin group, 3 percent of the people developed diabetes during the study period, compared with 2.4 percent in the placebo group.

Moreover, because the study was stopped early (so those in the placebo group could begin taking statins for their presumed heart benefits), it did not yield much insight into the drugs’ long-term safety. Nor is it clear that the early benefit shown in the statin group would have held up over a longer period or whether other risks might have emerged.

“This study does not indicate that we should be putting statins in the drinking water or fortifying cereal with statins,” said Dr. Goldberg, of N.Y.U. “There are millions of people who haven’t gone in and even gotten their cholesterol checked, but everybody wants the new thing. They want to believe the new thing will be the total answer.”

Statins may benefit healthy people too

The drugs can cut heart and stroke risks in people with normal cholesterol levels, researchers say

By Thomas H. Maugh II
16 nov 2008--In results from an eagerly anticipated study that could dramatically change the treatment of cardiovascular disease, researchers have found that statin drugs -- now given to millions of people with high cholesterol -- can halve the risk of heart attacks and stroke in seemingly healthy patients as well.

The study of nearly 18,000 people with normal cholesterol found that the drugs, already among the most widely prescribed in the country, also lowered the risk of death from heart disease by 20%, suggesting that millions more people should be put on a daily regimen.

The effects were so beneficial that the planned four-year study was halted after less than two years, researchers said Sunday at a New Orleans meeting of the American Heart Assn.

"These are very, very dramatic findings," said Dr. Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute.

Nabel, who was not involved in the research, noted that the institute already had an expert panel revising guidelines for treatment and prevention of heart disease and that the new results were likely to be included in its recommendations.

The revision would most likely call for testing a wide range of healthy people with a simple blood test for above-normal levels of a compound called C-reactive protein, which indicates increased arterial inflammation that can be treated with statins.

The new study focused on a specific drug -- rosuvastatin, sold as Crestor by drug maker AstraZeneca, which funded the research.

But Dr. Tim Gardner of the Christiana Care Health System in Wilmington, Del., and president of the American Heart Assn., said, "This is likely to be a class effect, not a specific drug effect. This is a win for all statins, I would say."

The new treatment could prevent 50,000 heart attacks, strokes and deaths each year if it were widely adopted, experts said.

The findings "really change what we are going to do in the future," said Dr. W. Douglas Weaver of Henry Ford Hospital in Detroit and president of the American College of Cardiology. "This targets a patient group that normally would not be screened or treated to prevent cardiovascular disease."

Critics, however, charged that such wide use would cost the U.S. healthcare system more than $9 billion a year at a time when healthcare costs are climbing dramatically and could expose large numbers of people to potential side effects.

Crestor is one of the most expensive statins, costing about $3.45 a day, but generic statins typically sell for less than $1.

About 120 people would have to take the drugs for two years to prevent one heart attack, stroke or death, Dr. Mark Hlatky of Stanford University wrote in an editorial accompanying the report, which was published online Sunday by the New England Journal of Medicine.

Nonetheless, the findings will most likely be widely adopted soon, Gardner said.

"It will be incorporated into practice guidelines after all the nuances are sorted out," he said.

Statins, first introduced in 1987, block the production of cholesterol in the liver. High cholesterol is a major risk factor for heart attacks and stroke because it contributes to the buildup of plaque that blocks arteries, preventing oxygenated blood from reaching the heart and brain.

An estimated 450,000 Americans die of heart disease each year and an additional 150,000 from strokes.

More than 13 million Americans take statins regularly, and worldwide sales total more than $22 billion a year, the bulk of that in the United States.

But doctors have long been mystified by the fact that about half of heart attacks occur in patients with normal cholesterol levels, and researchers have been looking for other important risk factors.

Three years ago, Dr. Paul Ridker of Brigham and Women's Hospital in Boston and his colleagues studied results from clinical trials in which statins had been used to treat high cholesterol levels and concluded that, in addition to their cholesterol-lowering ability, the drugs also reduced arterial inflammation, which can lead to the buildup of plaque.

The finding was part of a series of studies that showed statins have a number of beneficial effects beyond their ability to reduce cholesterol. Several reports have shown that they also help prevent glaucoma and cataracts and inhibit dementia.

Others suggest that they also moderate the symptoms of multiple sclerosis and increase bone density. These benefits may be related to their ability to reduce inflammation.

C-reactive protein, or CRP, has long been associated with inflammation. Very high levels of CRP are associated with arthritis and other autoimmune diseases. But slightly elevated levels -- about a hundredth of the levels seen in arthritis -- have been linked to inflammation in the arteries that causes cardiovascular diseases.

In the new trial, called Jupiter, Ridker and his colleagues studied 17,802 patients with normal cholesterol levels and elevated CRP, as measured by a test called high-sensitivity CRP, on which Ridker and his hospital hold the patent.

Men in the study were over 50; women were over 60. About 7,000 of the patients were women and 5,000 were minorities -- both groups that have not received much attention in previous statin trials.

Half of the patients received 20 milligrams of rosuvastatin and half a placebo.

"We specifically chose rosuvastatin because it is the most potent of the statins," said Ridker, who has worked as a consultant to AstraZeneca and other pharmaceutical companies. "We got very large effects on both [cholesterol] and CRP."

Low-density lipoproteins, the so-called bad cholesterol, were reduced by 50%, and CRP was reduced by 37%.

Patients receiving rosuvastatin had a 54% lower risk of heart attacks, a 48% lower risk of stroke and a 46% lower risk of requiring either angioplasty or bypass surgery, Ridker said.

There were 136 heart-related problems a year for every 10,000 people taking the placebo, compared with 77 for those taking rosuvastatin.

"This is very good news for these populations," Ridker said.

The primary side effect was a slight increase in newly diagnosed diabetes among those taking the drug, an increase that has also been noted in previous trials of statins.

Experts believe that the benefits of a regimen of statins for the targeted patient group outweigh any increase in side effects.

"This will become an important part of the armamentarium of the primary care doctor," Weaver said. "I see this as being part of that panel of preventions that they will be applying in men over 50 and women over 60."

The CRP test costs about $80.

Dr. James Stein and Dr. Jon Keevil of the University of Wisconsin, Madison, estimate that about 4% of the adult U.S. population, about 7.4 million people, fit the criteria to receive the test.

Reduction in Blood Pressure With Statins

Beatrice A. Golomb
21 april 2008-- Some studies have suggested reductions in blood pressure (BP)with statin treatment, particularly in persons with hypertension. Randomized trial evidence is limited.
We performed a randomized, double-blind, placebo-controlled trial with equal allocation to simvastatin, 20 mg; pravastatin sodium,40 mg; or placebo for 6 months. Nine hundred seventy-three men and women without known cardiovascular disease or diabetes mellitus, with low-density lipoprotein cholesterol screening levels of 115 to 190mg/dL, had assessment of systolic and diastolic BP (SBP and DBP, respectively). Blood pressure values were compared for placebo vs statins by intention-to-treat (ITT) analysis. Additional analyses were performed that (1) were confined to subjects with neither high baseline BP (SBP >140 mm Hg or DBP >90mm Hg) nor receiving BP medications, to exclude groups in whom BP medications or medication changes may have influenced results, and (2) separately evaluated simvastatin and pravastatin (vs placebo). The time course of BP changes after statin initiation and the effect of stopping statins on BP were examined.
Statins modestly but significantly reduced BP relative to placebo,by 2.2 mm Hg for SBP (P = .02) and 2.4mm Hg for DBP (P < .001) in ITT analysis.Blood pressure reductions ranged from 2.4 to 2.8 mm Hg for both SBP and DBP with both simvastatin and pravastatin, in those subjects with full follow-up, and without potential for influence by BP medications (ie, neither receiving nor meriting BP medications).

Conclusions Reductions in SBP and DBP occurred with hydrophilic and lipophilic statins and extended to normotensive subjects. These modest effects may contribute to the reduced risk of stroke and cardiovascular events reported on statins.

Tendon Problems Seen as Rare Adverse Effect of Statins

By Charles Bankhead
ROUEN, France, Feb. 28 -- Statin-related adverse effects are rare, and rarer still are tendinous complications, according to a large French post-marketing surveillance program.
Nevertheless, the French pharmacovigilance program confirmed anecdotal reports that every once in a while statins seem to trigger tendinitis or even an Achilles rupture, Isabelle Marie, M.D., Ph.D., of Rouen University Hospital, and colleagues reported in the March 15 issue of Arthritis & Rheumatism.
Tendinous complications accounted for about 2% of all statin adverse events reported to the French pharmacovigilance network from 1990 to 2005. For the individual years reviewed, the proportion of statin-related adverse effects that involved tendons ranged from 0% to 3.6%.
"Our series suggests that statin-attributed tendinous complications are rare, considering the huge number of statin prescriptions," the authors concluded. "We suggest that prescribers should be aware of tendinous complications related to statins, particularly in risk situations, including physical exertion and association with medications known to increase the toxicity of statins."
Statin-associated tendon impairment had not been reported in previous pre- and postmarketing studies, although sporadic anecdotal reports suggested a possible link. To explore the issue more closely, Dr. Marie and associates retrospectively reviewed data from 31 French pharmacovigilance centers.
For the 16-year period reviewed, 4,597 statin-related adverse events were reported to the pharmacovigilance network. Of those, 96 events (2.01%) involved tendon impairment, consisting of 63 reports of tendinitis and 33 reports of tendon rupture. The Achilles tendon was the affected area in 50 (52.1%) of the cases, and 26 patients (27%) had bilateral tendon manifestations.
The median time to onset of tendon symptoms was 243 days, but occurred as early as 24 hours after starting therapy and as late as 15 years. Tendon symptoms occurred within the first year in 59% of patients.
Statin-attributed tendon complications were considered serious in 36 cases, and 17 patients required hospitalization. Moreover, 19 of the 33 patients who had tendon rupture had significant functional sequelae that included difficulty walking, decreased range of motion, and pain. Of seven patients who stopped and then reinitiated statin therapy, all seven had a recurrence of tendon symptoms.
Tendon complications were reported in patients treated with atorvastatin (Lipitor), simvastatin, pravastatin, fluvastatin (Lescol), and rosuvastatin (Crestor). The authors reported that the complications occurred at recommended dose ranges for all of the drugs.
Predisposing factors beyond statin therapy that might have led to tendon complications were not explored.
Though generally considered safe and associated with minor side effects, statins occasionally cause serious complications, especially musculoskeletal effects that include myositis, rare cases of rhabdomyolysis, and inflammatory myopathies. In clinical trials of statins, myositis occurred in 0.09% to 0.63% of patients and rhabdomyolysis in 1 case per 100,000 patient-years, the authors noted.
Despite their findings, the authors left the door open to the possibility that statins have a closer association with tendon problems than currently recognized. They noted that a literature review uncovered 43 cases of statin-related tendon complications.
"Tendinous manifestations may be an as-yet unreported side effect of statin therapy," they said. "In essence, no cases were reported during the large therapeutic trials, including more than 30,000 patients. However, the fact that statin-related tendon complications have not been described in these large clinical trials may be explained in part by control of factors predisposing to tendinopathy and regular follow-up of trial patients."
They concluded that this literature review suggests that tendon manifestations may be included within the spectrum of adverse effects of statins but future case-control studies are required to confirm this relationship.
"Our study suggests that regular tendinous clinical examination may be required in statin-treated patients, particularly during the first year following statin therapy initiation," they added.
The authors had no disclosures.
Primary source: Arthritis & RheumatismSource reference:Marie I, et al "Tendinous disorders attributed to statins: A study on ninety-six spontaneous reports in the period 1990-2005 and review of the literature" Arthritis Rheum 2008; 59: 367-372.

Statins Reduce Cardiovascular Risk in Patients with Diabetes

By Charles Bankhead
OXFORD, England, Jan. 10 -- All diabetes patients may benefit from statin therapy to reduce their risk of occlusive vascular events, suggested a prospective meta-analysis here.
In the analysis of nearly 20,000 patients with type 1 or 2 diabetes, all-cause mortality decreased by 9% with every 1 mmol/L decline in LDLs, the international Cholesterol Treatment Trialists' Collaborators reported in the Jan. 12 issue of The Lancet.
The benefit was similar to the 13% reduction in mortality risk in nondiabetic patients, they found.
Diabetic and nondiabetic patients alike had a 21% reduction in vascular events with each mmol/L decrease in LDLs. Statin therapy significantly reduced the risk of myocardial infarction and coronary death, coronary revascularization, and stroke.
"Among people with diabetes the proportional effects of statin therapy were similar irrespective of whether there was a prior history of vascular disease and irrespective of other baseline characteristics," the authors wrote.
They concluded, "Since the absolute size of the benefit depends chiefly on the absolute reduction in LDL cholesterol that is achieved, present guidelines might need to be revised to ensure that a statin regimen which is sufficient to produce a substantial reduction in LDL cholesterol is considered for all people with diabetes, irrespective of whether vascular disease has developed and irrespective of lipid profile."
In a previous meta-analysis of 14 randomized trials of statin therapy, the Cholesterol Treatment Trialists' Collaboration found that every 1 mmol/L decline in LDL cholesterol was associated with about a 20% decrease in the risk of vascular events in a wide range of high-risk patients. However, some uncertainty persisted about the effects of statins in patients with diabetes.
"For example, there is little information about the separate effects on major coronary events … on stroke, and on the need for coronary revascularization," the authors noted. "Moreover, whether the benefits of statin therapy are worthwhile in people with diabetes who do not have any history of occlusive vascular disease is unknown."
In an effort to eliminate some of the uncertainty, the investigators performed prespecified analyses of the 18,686 diabetic participants (1,466 type 1 and 17,200 type 2) in the 14 statin trials included in the original meta-analysis. The trials included a total of 71,370 nondiabetic patients. Clinical outcomes were defined in terms of the effects associated with each 1 mmol/L reduction in LDL.
During a mean follow-up of 4.3 years, 3,247 major vascular events occurred in patients with diabetes. The per-mmol/L decline in all-cause mortality was statistically significant in diabetic (P=0.02) and nondiabetic patients (P<0.0001). The overall benefit for patients with diabetes reflected a significant reduction in vascular mortality (relative risk: 0.87, 95% CI: 0.76 to 1.00, P=0.008) and no effect on nonvascular mortality (RR: 0.97, 95% CI: 0.82 to 1.16).
Among diabetic patients, statin therapy was associated with a:
22% reduction in the risk of MI or coronary death (P<0.0001)
25% reduction in the rate of coronary revascularization (P<0.0001)
21% reduction in stroke risk (P=0.0002)
After five years, 42 fewer diabetic patients had major vascular events per 1,000 treated with a statin.
In a commentary that accompanied the report, Bernard M. Y. Cheung, M.D., of the University of Birmingham in England, acknowledged statins as one of the "most notable triumphs of modern medicine." However, he cautioned that statins are not a panacea, as treated patients remain at risk for other causes of mortality and morbidity.
Dr. Cheung also noted that the new meta-analysis did not include three recent negative trials of statin therapy in patients with diabetes. However, each of the negative trials demonstrated a trend toward lower event rates, favoring statin therapy, he added.
"In any case, treatment decisions should be based not on the reduction in relative risk but on the reduction in absolute risk or its reciprocal, the number needed to treat," Dr. Cheung wrote.
"Additionally, one should consider life expectancy, concomitant diseases, and quality of life," he continued. "Apart from drug treatment, one must not forget the importance of lifestyle changes."
The Cholesterol Treatment Trialists' Collaborators disclosed that several members of the writing committee had received reimbursement of travel costs to meetings from representatives of the pharmaceutical industry. They also noted that most of the trials included in the meta-analysis were supported by the pharmaceutical industry. Dr. Cheung disclosed financial support from statin-makers to organize, attend, or speak at scientific conferences.
Primary source: The LancetSource reference:Cholesterol Treatment Trialists' (CTT) Collaborators. "Efficacy of cholesterol-lowering therapy in 18,686 people with diabetes in 14 randomized trials of statins: a meta-analysis" Lancet 2008; 371: 117-125. Additional source: The LancetSource reference: Cheung BMY, "Statins for people with diabetes" Lancet 2008; 371: 94-95.

Meta-Analysis Shows Statins Reduce All-Cause Mortality 22% in Elderly CHD Patients

Michael O'Riordan
In elderly patients with documented coronary heart disease (CHD), statins reduce all-cause mortality, as well as CHD mortality, nonfatal myocardial infarction, the need for revascularization, and stroke, a new review has shown [1]. Investigators say that the magnitude of benefit, with statins reducing all-cause mortality 22%, is larger than previously estimated.
"Despite having as many positive statin trials as we do, concerns have been raised about a lack of hard evidence with statins in elderly patients, mainly because there have been limited data showing a reduction in all-cause mortality," said lead investigator Dr Jonathan Afilalo (McGill University, Montreal, QC). "We hope that this study will reawaken an awareness in clinicians that this is a proven therapy that is being significantly underutilized in our highest-risk patients."
The results of the study are published in the January 1, 2008 issue of the Journal of the American College of Cardiology.
Some Doubt About the Benefits of Statins in Elderly
Speaking with heartwire, Afilalo said that despite the recommendations of the National Cholesterol Education Program Adult Treatment Program (NCEP ATP III) to lower LDL cholesterol levels in elderly CHD patients, the use of statins in these patients remains low, hovering between 40% and 60%.
"As much as statins have garnered a good reputation in cardiology, we still see in the literature that the prescription rates, even among elderly patients who have had a recent myocardial infarction, are low," said Afilalo. "We're talking about half of these high-risk patients with active coronary heart disease not receiving statins."
The underutilization, he said, stems from inconsistencies in the data showing the effectiveness of statins to reduce mortality in elderly patients. Specifically, concerns were raised after the publication of the Prospective Study of Pravastatin in the Elderly at Risk (PROSPER) trial, a study that failed to show an effect of statin therapy on all-cause mortality in patients 70 to 82 years old with cardiovascular risk factors or documented cardiovascular disease. The published PROSPER data, however, did not present results stratified by the primary and secondary cohorts, leaving questions about the possible benefits of statins in the secondary-prevention patients.
With these inconsistencies in mind, the investigators performed a meta-analysis to determine if statins reduce all-cause mortality in elderly CHD patients, and to quantify the treatment effect. The group included nine studies, consisting of 19 569 patients between 65 and 82 years of age. In addition to studies publishing data on elderly subgroups, including the 4S, CARE, LIPID, and HPS studies, the investigators obtained unpublished data on elderly subgroups and on the secondary-prevention subgroup in the PROSPER trial.
Overall, the review showed that the use of statins for secondary prevention in elderly patients with documented CHD reduced all-cause mortality 22% and reduced CHD mortality 30%. Nonfatal myocardial infarction was reduced 26%, the need for revascularization 30%, and stroke 25%. Afilalo said the benefit is larger than expected, mainly because two meta-analyses of young and elderly patients showed that the number needed to treat to save one patient was 56 and 61, respectively. In this meta-analysis focused on elderly patients, the number needed to treat to save one patient was 28.
The investigators did not pool rates of adverse events in their meta-analysis, mainly because the different studies used different definitions of adverse events and reported these events differently. Afilalo told heartwire, however, that elderly patients do not experience higher rates of serious adverse events than younger patients. There are higher rates of myalgia typically reported in the elderly, both in the placebo and statin arms, partly because the elderly have more aches and pains, he noted.
Evidence-Based Reimbursement
In an editorial accompanying the published study [2], Drs George Diamond and Sanjay Kaul (University of California Los Angeles) write that two practical problems continue to plague statin therapy in clinical practice: long-term adherence remains poor; and the treatment gap, especially among the elderly, remains large.
"Meanwhile, the use of PCI continues to increase despite the lack of equivalent evidence of outcomes benefit," write the editorialists. "Current reimbursement policy actually encourages such misuse. Once drugs and devices are approved for marketing, physicians often use them in unapproved ways, and payers reimburse such 'off-label' use to the same degree as 'on-label' use. Fine tuning these financial incentives might help to close the treatment gap and increase adherence to statin therapy."
Diamond and Kaul propose that the Centers for Medicare and Medicaid discount a drug's price not by some fixed amount, but rather in direct proportion to its proven therapeutic benefit. With various incentives in place, the patient could receive better access to proven drugs at more affordable prices. They even suggest empowering the US Food and Drug Administration advisory panels with additional authority to discount the drug's cost on the basis of the scientific evidence they are already reviewing.
The statin treatment gap, Diamond and Kaul argue, is an example of the disconnect between what the providers of care should do, according to the evidence, and what they are paid to do, according to reimbursement policies.
"This situation will not change unless and until we realign the financial and scientific incentives and begin rewarding caregivers, not for the prodigal provision of products and services, but for the enlightened provision of therapeutic benefit," they write. "Evidence-based reimbursement can be the bridge to [a] 'far, far better thing'."
Afilalo J, Duque G, Steele R, et al. Statins for secondary prevention in elderly patients. J Am Coll Cardiol 2008; 51:37-45.
Diamond GA, Kaul S. Prevention and treatment: a tale of two strategies. J Am Coll Cardiol 2008; 51:46-48

Stopping Statins After Stroke Raises Risk for Death, Dependence

Caroline Cassels

August 30, 2007 — Individuals who stop statin treatment after hospitalization for ischemic stroke have nearly a 5-fold increased risk for death or dependence within 3 months poststroke, a new study suggests.
In addition, patients who are withdrawn from statin therapy during the acute phase of stroke have almost a 9-fold increased risk for early neurologic deterioration (END) and larger infarct volumes.
"These results strongly support the recommendation to physicians to continue statin drugs during the acute phase of an ischemic stroke," the study's principal investigator, José Castillo, MD, PhD, from the University of Santiago de Compostela, in Santiago, Spain, said in a statement from the American Academy of Neurology.
Dr. Castillo added that while no protocols suggest patients should not receive statins after stroke, in many cases the drugs are discontinued to avoid bronchoaspiration, particularly in the most severe strokes. "This study clearly shows the benefits of continuing statin use," he said.
The study is published in the August 28 issue of Neurology.
The single-center analysis included 215 consecutive patients hospitalized for acute hemispheric ischemic stroke and admitted within 24 hours of symptom onset from October 2003 to May 2005.
Of these, 89 subjects who were on previous statin therapy were randomized to receive 20 mg daily of atorvastatin (administered orally or through a nasogastric tube) or were taken off statins for 3 days immediately following stroke.
Patients who had not been on statin therapy prior to admission were followed up as a reference group for secondary analysis.
From the fourth day onward, atorvastatin 20 mg daily was also administered to patients in the withdrawal group and in those who were not on previous statin treatment.
Greater Infarct Volume
The primary outcome was death or dependence at 3 months, defined as a modified Rankin Scale of greater than 2. Secondary outcomes were infarct volume and END, defined as an increase in National Institutes of Health Stroke Scale (NIHSS) of 4 points or more between time of admission and any time during the first 48 hours of hospitalization.
After 3 months, 60% (27) of those in the statin-withdrawal group had either died or were disabled to the point of dependence compared with 39% (16) of those who had continuous statin therapy.
The authors also report that infarct volume was greater in statin-withdrawal patients compared with those who remained on statin therapy.
In addition, secondary analysis revealed patients in the reference group had a higher frequency of atrial fibrillation and were less likely to have a previous history of hypercholesterolemia than randomized patients.
Statin Therapy Should Not Be Interrupted
Post hoc analysis showed no difference in the study's primary outcome among the statin-withdrawal group and the reference group. However, the researchers observed a 19-fold increased risk for END among patients who were withdrawn from statin therapy compared with referent subjects.
According to the authors, previous animal and clinical research has shown the neuroprotective effect of statins is related not only to the reduction of plasma cholesterol but also to their direct influence on improving endothelial function through the overexpression of nitric-oxide synthase, as well as their antithrombotic and anti-inflammatory effects.
While the optimal dose of statins for neuroprotection in ischemic stroke is not known, animal studies of cerebral ischemia indicate neuroprotection is more likely at lower doses.
"Our findings strongly support that previous statin therapy should not be interrupted during the acute phase of ischemic stroke. The recommendation to start on statin treatment as soon as ischemic stroke occurs needs to be investigated in further randomized trials," they write.
The study was partially supported by grants from the Spanish Ministry of Health. Dr. Castillo and coauthors José Vivancos, MD, PhD, and Antonio Dávalo, MD, PhD, are scientific advisors to Pfizer. The other study authors report no conflicts of interest.
Neurology. 2007;69:904-910. Abstract

Statins may help prevent Alzheimer's: study
Mon Aug 27, 4:33 PM ET

Statin drugs may help prevent the brain damage that leads to Alzheimer's disease, U.S. researchers reported on Monday.
Their study, published in the journal Neurology, bolsters a growing body of research that suggests the popular cholesterol-lowering drugs may reduce the risk of Alzheimer's.
Most studies have simply compared people who take statin drugs to those who do not, and track the rate of Alzheimer's.
"But our study is the first to compare the brains of people who had received statins with those who had not," said Dr. Gail Ge Li of the University of Washington School of Medicine in Seattle, who worked on the study.
Li and colleagues examined the brains of 110 people aged 65 to 79 who had donated their brains for research after they died as part of a study when they were still living.
The researchers looked at the brains for evidence of the plaques and tangles that characterize Alzheimer's, an incurable and progressive brain disease that is the leading cause of dementia.
They found significantly fewer tangles in the brains of people who had taken statins than in those who had not.
"These results are exciting, novel, and have important implications for prevention strategies," said Dr. Eric Larson, who helped direct the study.
"But they need to be confirmed, because (ours) is not a randomized controlled trial."
Such a trial would be difficult to conduct. It would require randomly assigning people to either take statins or not, watching to see who developed Alzheimer's, and looking at their brains after they died.
Statin drugs lower cholesterol and may also reduce inflammation in the body. The causes of Alzheimer's are not fully understood, but they are closely linked with cholesterol and also inflammation.
"Statins are probably more likely to help prevent the disease in certain kinds of people than others," Li said.
"Someday we may be able to know more precisely which individuals will benefit from which types of statins for preventing the changes of Alzheimer's disease," Larson added in a statement.

Statins Fail to Cut the Androgens that Fuel Prostate Cancer

WATERTOWN, Mass. Aug. 10 -- Statins do not seem to reduce production of circulating testosterone and related androgens, researchers here reported.
Although the men using statins in a large population-based study had lower androgen levels, the associations vanished in a covariate analysis and were probably due to other health problems, Susan A. Hall, Ph.D., of the New England Research Institutes here, and colleagues, reported in the August issue of Cancer Epidemiology, Biomarkers & Prevention.
It is possible the statins may lower prostate cancer risk through one or more alternative pathways, but reduction in male hormones does not seem to be one of them, Dr. Hall said.
Although some studies have shown no effect of statins on prostate cancer, a recent large cohort study showed a substantially reduced risk of metastatic disease among statin users.
Reduction of cholesterol, a testosterone precursor, might influence the biology and progression of prostate cancer, the researchers wrote. However, they said, the effect of statins on circulating androgen levels in men has not been considered in an epidemiologic study.
In a narrow study focused solely on hormone levels, the researchers determined whether statin use affected levels of circulating androgens and their carrier protein, sex hormone-binding globulin (SHBG).
The study included 1,812 men derived from the population-based Boston Area Community Health (BACH) survey. From 2002 through 2005, the BACH survey collected data on 5,500 men and women with equal representation of African Americans, Caucasians, and Hispanics.
Statin exposure was collected through self-reports or interviewer-recorded information, or both. Multivariate linear models were then constructed to account for potential confounding.
Only 237 men (12.4%) used statins (95% confidence interval 10.3-14.9). On average, statin users were older, had a larger body mass index (BMI), more chronic illnesses, and used more medications.
The researchers measured serum levels of total testosterone, free testosterone, dehydroepiandrosterone sulfate, luteinizing hormone, and SHBG. They found no relationship between statin use and free testosterone, dehydroepiandrosterone sulfate, or LH.
A significant association between statin use and total testosterone was seen at first but was did not hold after covariate control in a multivariate model that included age, body mass index, time since awakening, and history of cardiovascular disease, and diabetes (-5.5%; CI, -13.2% to 2.9%).
Men with a higher BMI, diabetes, and cardiovascular disease tend to have lower testosterone levels, and this largely accounted for the drop in testosterone in statin users," Dr. Hall said.
However, after a similar adjustment, SHBG levels among statin users were 11% lower than among nonusers (-10.6%; CI, -18.8 to -1.6%). The findings remained robust even after controlling for BMI and other covariates, the researchers said.
Although it was not possible to rule out a direct effect of statins on the protein carrier, intervention trials have not shown such an effect on men with dyslipidemia.
A more likely explanation, the researchers said, is the effect of circulating insulin on SHBG production. Statin users tend to have higher levels of circulating insulin than non users, and higher levels would drive down SHBG levels in these individuals.
The statins used in this study included mainly atorvastatin (Lipitor) for 73.4%, followed by simvastatin (Zocor) for 16.4%, as well as pravastatin (Pravachol), lovastatin (Mevacor), fluvastatin (Lescol) and rosuvastatin (Crestor).
Statin users were different from nonusers on most covariates, the researchers said. They were likely to be older, have a higher BMI, and were more likely to have clinically low total testosterone and comorbid diseases, such as diabetes, hypertension, and cardiovascular ills. Consequently they were more likely to be taking other medications than non-statin users.
Study limitations included the lack of information about dose and duration of use. The relatively small sample of 237 statin users limited examination of subgroups, and the preponderance of atorvastatin limited the ability to consider other types of statins.
In assessing the results, the researchers said that despite the lack of effects of statins on serum androgen levels in this study, "we cannot rule out the possibility that statins may modulate steroid synthesis in prostate tissues."
The mechanisms by which prostatic tissue maintains tissue androgens may include metabolism of adrenal androgens or fresh synthesis from cholesterol.
Statins could influence disease progression by several different effects including increasing prostate epithelial cell sensitivity to apoptosis.
This study suggests that a protective pathway offered by statins, if it exists, is not through androgen suppression. Thus further studies of statin use in prostate cancer are warranted, Dr. Hall said.
No financial conflicts were reported. The BACH Survey was supported by the National Institutes of Diabetes and Digestive and Kidney Diseases.Additional source: Cancer Epidemiology Biomarkers & PreventionSource reference: Hall SA, et al "Do Statins Affect Androgen Levels in Men? Results from the Boston Area Community Health Survey" Cancer Epidemiol Biomarkers Prev 2007; 16:1587-1594.

Patients Know Statins Are Not Tickets to Cheeseburger Heaven

NEW YORK, Aug. 2 -- Patients seem to get the message that a prescription for a statin does not give them carte blanche to jump off the dietary wagon, investigators here found.
A survey of patients with new statin prescriptions showed that, although 70% believed statin use would cure their hyperlipidemia, six months later they had made no significant changes in their intake of saturated fats, reported Devin M. Mann, M.D., M.S., of Mount Sinai School of Medicine, and colleagues.
Among 62 patients who completed the six-month dietary recall, the mean saturated fat intake was 24 + 18 g at baseline, and 22 + 11 g at six months (P=0.19), they wrote in the August issue of Mayo Clinic Proceedings.
"The results of this study should reassure clinicians that the use of statins for primary prevention may not hinder concurrent dietary interventions. Very few patients used statin therapy as an excuse to increase fat intake," they said.
But the authors also noted that nearly half of all patients in the small study said they thought they didn't need lipid-lowering drugs or wanted more time to see whether dietary changes could work, indicating a discordance between physician and patient preferences.
The authors conducted a study to see whether patients on statins would view the drugs as license to indulge in ice cream or other foods high in saturated fat.
They interviewed 71 patients who had received a first statin prescription for primary prevention of cardiovascular disease within the previous two weeks.
They asked the patients at baseline and at three and six months about their beliefs regarding diet and medication and had them rank responses to statements such as "I am motivated to reduce fat in my diet", "I am currently eating a healthy diet," and "Statin use is easier than diet for lowering cholesterol."
The authors also asked patients at all visits what they had eaten over the past 24 hours, and about medication adherence at three and six months.
They found that, at baseline, 76% of the participants said they wanted to reduce dietary fat and 70% said that statin used could cure their hyperlipidemia.
"Although most patients (n=56, 79%) said they preferred to try diet control before starting a statin, only half (n=36, 52%) reported actually trying to modify their diet," the authors wrote.
In all, 39% of the patients were given a prescription for a statin even though they said they wanted to try changing their diets first, and 43% said their physicians jumped the gun by giving them a prescription before they had a chance to see if diet alone might work to lower their cholesterol levels.
Most of the patients who tried changing their diets (74%) did so for less than six months.
"Over time, attitudes toward both dietary change and statins to manage hyperlipidemia tended to become more positive," the authors wrote. "We found no evidence that favorable attitudes toward diet were weakened after initiation of statin therapy."
The only significant changes in diet occurred among those patients who were poorly adherent to the statin regimen. They reduced their mean caloric intake from 2,110 + 782 at baseline to 1,887 + 612 at six months (P=0.04).
The same group also increased its fiber intake from 14 + 8 g daily at study outset to 17 + 10 at the end (P=0.03).
And even among those patients who were less adherent to their prescribed statins, there was trend toward maintaining a healthier diet, the investigators noted.
They acknowledged that the study was limited by its small sample size and by the lack of a control group.Primary source: Mayo Clinic ProceedingsSource reference: Mann DM et al. "Dietary Indiscretion and Statin Use." August 2007;82(8)

Statin May Reduce Risk of Dementia and Parkinson's Disease

BOSTON, July 19 -- Simvastatin (Zocor) may enrich the brain as well as help sustain the heart, according to researchers here.
The statin reduced the risk of incident dementia by more than 54% and the risk of newly acquired Parkinson's disease by 49% in patients 65 or older, Benjamin Wolozin, M.D., of Boston University, and colleagues, reported online in BMC Medicine
Analysis of data from the 4.5 million men and women included in the Veterans Affairs database found a significant protective effect for simvastatin (P <0.0001 for both), but not for lovastatin (Mevacor), Benjamin Wolozin, M.D., of Boston University School of Medicine, and colleagues reported online in BMC Medicine.
There was also a non-significant reduction in risk of incident dementia among patients taking atorvastatin (Lipitor) (HR 0.91, 95% CI 0.80-1.02, P =0.11), they wrote.
They compared those taking lovastatin, atorvastatin, or simvastatin with those using warfarin (Coumadin) or an unidentified mixture of other cardiovascular drugs. The data were analyzed using three Cox proportional hazard models, one that adjusted for age, a second that adjusted for hypertension, cardiovascular disease or diabetes, all known risk factors for dementia, and a third that included the Charlson index, which is used to assess severity of chronic disease.
The study included data from 1,290,071 participants who took some type of cardiovascular medicine including 727,128 who used simvastatin, 53,869 who took atrovastatin, 53,369 who took warfarin, and 54,052 lovastatin users. It also included data from 394,739 patients who used a variety of cardiovascular drugs.
Among the findings:
After adjusting for age, presence of known dementia risk factors, and Charlson index, simvastatin was associated with a 54% reduction in risk of incident dementia (HR 0.46, 95% CI 0.44-0.48, P <0.0001).
After adjusting for age, presence of known dementia risk factors, and Charlson index, lovastatin was associated with a non-significant 5% reduction in risk of incident dementia (HR 0.95, 95% CI 0.86-1.05, P =0.34).
After adjusting for age, presence of diabetes, hypertension, or other cardiovascular disease, the HR for new onset Parkinson's disease was 0.51 for patients taking simvastatin (95% CI 0.49-0.55 P <0.0001).
The authors said although the large sample size, the ability to track subjects using a comprehensive database, and the ability to analyze the data by specific statin type were all strengths of the study, the results were nonetheless limited by its retrospective design. Some of these limitations were offset by the use of two comparators-warfarin and the catchall cardiovascular drugs category.
But as the authors concluded, more studies are needed to determine whether the apparent protective effect "represents a biological action of simvastatin or an unanticipated statistical bias in the database."
Dr. Wolozin disclosed that he had a patent for the use of statin therapy for Alzheimer's disease. The authors said the study was supported by "an anonymous foundation." Additional source: BMC MedicineSource reference: Wolozin B et al "Simvastatin is associated with a reduced incidence of dementia" BMC Medicine 2007 (in press)

Higher statin dose cuts heart risk in elderly

By David DouglasThu Jul 12, 3:19 PM ET
For elderly patients with coronary disease, treatment with high doses of cholesterol-lowering Lipitor (known generically as atorvastatin) reduces the risk of heart-related events more than low doses, according to a new report.
Aggressive lowering of LDL ("bad") cholesterol with high doses of atorvastatin, compared with routine cholesterol lowering with low doses, produces additional clinical benefit in elderly heart patients, Dr. Nanette K. Wenger told Reuters Health.
Wenger, of Emory University School of Medicine, Atlanta and colleagues came to this conclusion after analyzing data on some 3800 subjects aged 65 years or more who formed part of a group of 10,000 people with coronary disease who were taking part in a clinical trial of atorvastatin.
As reported in the Annals of Internal Medicine, all patients had LDL cholesterol levels below 130 points and were randomly assigned to take 10 milligrams or 80 milligrams of atorvastatin daily.
The usual goal of cholesterol-lowering is to get LDL levels below 100 milligrams per deciliter of blood, but recent guidelines have suggested that the target should be lower for anyone with actual coronary heart disease.
The investigators found that the high-dose regimen led to LDL levels of about 70, while with low-dose treatment the levels were about 100.
The likelihood of suffering a heart attack or stroke or cardiac arrest was 19 percent lower with high-dose atorvastatin compared to low-dose treatment.
Moreover, mortality rates among high-dose patients were lower than was the case for their counterparts on the low-dose regimen.
The researchers conclude that "additional clinical benefit can be achieved by treating older patients with coronary heart diseases more aggressively to reduce low-density lipoprotein cholesterol levels to less than ... 100 mg/dL."
SOURCE: Annals of Internal Medicine, July 3, 2007.