CHICAGO — Should healthy people with low cholesterol take a pill to lower their cholesterol even more in hopes of preventing heart problems? The question is dividing doctors and confusing patients.
An analysis published Monday questions research that led federal regulators to allow wider use of the statin drug Crestor for prevention. The Food and Drug Administration broadened Crestor’s market to millions more people in February, partly because of a study reported in 2008 by Crestor’s maker, AstraZeneca PLC.
Consequently, more doctors are putting healthy people on statin drugs, sometimes inappropriately, heart doctors say. And they say too little attention is paid to potential risks, such as developing diabetes.
The AstraZeneca-funded study was controversial from the start. Its findings: Crestor cut the risk of certain heart problems in half for the middle-aged and older men and women in the study who had normal levels of LDL, or “bad” cholesterol (below 130), and high levels of a measure of inflammation called C-reactive protein, CRP. It not only suggested a new use for Crestor but a new blood test for CRP.
Critics suggested the dramatic results might be exaggerated because the experiment was stopped after two years instead of the planned five. They questioned why the authors didn’t report the rates of death from heart attack and stroke, which when teased out of the data turned out to be unaffected by Crestor.
The new analysis, in the Archives of Internal Medicine, raises those questions again. A second paper in the same journal finds no justification for using a test for CRP to make treatment decisions. And a third paper, an analysis of 11 published studies including the 2008 study, finds no evidence statins help high-risk people without heart disease live longer.
