January 19, 2011

Questionable Benefits Of Statins For Low-risk Patients

Healthy people may derive no benefit from taking cholesterol-lowering statins, according to a review of previous studies.

The report, published in The Cochrane Library concluded that statins reduced death rates in high-risk patients but said there was no evidence to justify their use in people at low risk of developing heart disease.

The National Institute for Health and Clinical Excellence recommends statins for people who have a 20 percent or greater chance of developing cardiovascular disease within ten years. Statins are available both as a prescription and in low doses over-the-counter in pharmacies.

Previous studies have suggested that statins may benefit the healthy, but the drugs have also been linked to a range of side effects including liver problems, kidney failure and muscle weakness. This study, which reviewed the evidence from 14 trials, said there was insufficient evidence that statins should be taken by those not in at-risk groups.

Fiona Taylor, from the Cochrane Heart Group at the London School of Hygiene and Tropical Medicine, told Reuters: "This review highlights important shortcomings in our knowledge about the effects of statins in people who have no previous history of cardiovascular disease. The decision to prescribe statins in this group should not be taken lightly."

Statins -- including Pfizer's Lipitor and AstraZeneca's Crestor -- help prevent new heart attacks in people who have already had one, but the effects are less certain in individuals at lower risk. The drugs also appeared to reduce the number of heart attacks and strokes and the need for surgery.

While there appeared to be no difference in side effects between trial participants taking dummy pills and statins, the researchers say those results aren't credible. Any appraisal we can make of adverse events is biased by failure to report these events," Dr. Shah Ebrahim told Reuters.

But Ebrahim advised people to think twice before buying the drug, even if they have raised cholesterol levels. "If you have self-prescribed a statin, buy it "over-the-counter" in a pharmacy, or do not know your level of risk and are taking a statin, get a check of your level of cardiovascular risk and discuss your decision with your family doctor," he urged.

Pfizer said it was still reviewing the new report, but noted that the safety and efficacy of Lipitor has been studied in more than 80,000 patients. "Managing cardiovascular disease risk factors is complicated, and prescribing decisions should be based on a physician's full assessment of each patient's individual risk factors and needs," said spokesman MacKay Jimeson to Reuters.

Dr. Franz Messerli, who heads the hypertension program at two New York hospitals, St. Luke's and Roosevelt, echoed the cautious message from the British researchers. "While statins are pretty safe drugs," Messerli said, "they may cause muscle and joint pain in some patients and their long-term effect on muscle tissue is unknown. If you have a very small benefit, you better make sure that the downside is minimal," he told Reuters Health.


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