Study raises questions over wider use of statins

LONDON (Reuters) - There is no evidence that prescribing cholesterol-lowering drugs known as statins to patients at risk of heart disease reduces their chances of premature death in the short term, scientists said on Monday.

The results of a study by British researchers call into question the expanded use of statins such as Pfizer's Lipitor and AstraZeneca's Crestor in patients who do not have heart disease but may develop it.

Statins are one of the most widely used drugs for the treatment and prevention of heart disease, both among people who already have it and among high-risk but healthy people. They are among the most successful drugs of all time and have been credited with preventing millions of heart attacks and strokes.

But in a meta-analysis -- a study which reviews all previous published scientific evidence on a specific area -- Professor Kausik Ray and colleagues from the University of Cambridge and Addenbrooke's Hospital found scant evidence that statins saved lives in the short term in groups without heart disease.

"There is little evidence that statins reduce the risk of dying from any cause in individuals without heart disease," they wrote in the study in Archives of Internal Medicine journal.

"This, along with harms caused by statins in some subgroups, have called into question the benefit of statins in primary prevention (prevention of the development of heart disease)."

Heart disease is the biggest killer of men and women in the rich world and is also a growing problem in developing nations.

SIDE EFFECTS

Although statins are widely seen as safe and effective drugs, a study published last month found that people taking them may have higher risks of liver dysfunction, kidney failure, muscle weakness and cataracts. Scientists have warned such side effects should be closely monitored.

In their analysis, the Cambridge team combined data from 11 studies involving 65,229 people. A total of 32,623 individuals were assigned to take statins and 32,606 individuals were assigned to take placebo.

Over an average of 3.7 years of follow-up, 2,793 participants died, including 1,447 on placebo and 1,346 on statins. The scientists said the small reduction in the statin group was not statistically significant.

While low-density lipoprotein (LDL), or "bad" cholesterol levels, were higher among those taking placebo than those taking statins (134 milligrams per deciliter versus 94 milligrams per deciliter), this had no effect on the risk of premature death.

The scientists said their results showed "the need for caution when extending the potential benefits of statins to a wider population."

Professor Peter Weissberg of the British Heart Foundation noted the findings but said they were only short-term.

"The people in these studies were followed for less than four years on average. Since heart and circulatory disease develops over many decades, it's reasonable to assume that we would see a significant improvement in mortality after a longer period of follow-up," he said in a statement.

He also said premature death was not the only consideration when seeking to prevent heart disease.

"Many studies have shown that statins prevent non-fatal heart attacks and strokes," he said. "Preventing serious ill health, such as heart failure resulting from a heart attack, or disability due to a stroke, is every bit as important as lengthening lives."

(Editing by David Holmes)