By Ed Silverman //
AstraZeneca recently received FDA approval to market its Crestor cholesterol fighter as a preventive pill for millions of folks who don’t have high cholesterol – and that prompts some to wonder whether this is a good idea, The New York Times writes. The skeptics point to concern that cholesterol meds may not be as safe as a preventive drug as previously believed for people who are at low risk of heart attacks or strokes. Others suggest the benefits may not outweigh side effects.
One risk – a recent paper indicated that statins could raise the risk of developing Type 2 diabetes by 9 percent, the paper continues. “It’s a good thing to be skeptical about whether there may be long-term harm from healthy people taking a drug like this,” Mark Hlatky, a professor of health research and cardiovascular medicine at the Stanford University medical school, tells the Times.
There is also debate over the blood test used to identify new patients. Instead of looking for bad cholesterol, the test measures the degree of inflammation in the body, but there is no consensus that inflammation directly causes cardiovascular problems.The clinical trial on which the FDA approved the new use looked only at patients who had low cholesterol and an elevated level of inflammation in the body measured by a test called high-sensitivity C-reactive protein, or CRP, the Times writes.
Crestor may be given to apparently healthy people — men 50 and over and women 60 and over — who have one risk factor like smoking or high blood pressure, besides elevated inflammation. However, in the trial, the heart attack rate was 0.37 percent, or 68 patients out of 8,901 given a placebo. Among Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between groups is 0.2 percentage points in absolute terms — or 2 people out of 1,000, the Times notes, adding that 500 people would need to be treated for a year to avoid one usually survivable heart attack.
Eric Colman, a deputy director of the FDA’s Center for Drug Evaluation, tells the paper that the decision provided an option, not a mandate for docs. However, “the benefit is vanishingly small,” cardiologist Steve Seiden tells the Times. “It just turns a lot of healthy people into patients and commits them to a lifetime of medication.”