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January 5, 2005

High-Dose Statins in Acute Coronary Syndromes

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(1):36-39. doi:10.1001/jama.293.1.37-b

To the Editor: In his editorial1 on statins in the treatment of ACS, Dr Nissen likely overstates the benefit and understates the risks of more aggressive therapy. All of the studies quoted had high dropout rates (10.8% for 16 weeks in the MIRACL trial; 31.7% for 2 years in the PROVE IT trial; and 32.8% for 2 years in the A to Z trial).24 The broad composite clinical end points that were used in the atorvastatin studies were driven primarily by softer end points such as hospitalizations for unstable angina. Hard end points such as death or fatal and nonfatal myocardial infarctions were not affected by the more aggressive statin therapy (although longer study durations may have shown such an effect). These findings contrast with less aggressive therapies in the Scandinavian Simvastatin Survival Study5 (4S) and in the Cholesterol and Recurrent Events (CARE) trial6 in which hard end points (death or fatal and nonfatal myocardial infarction) were reduced and the drop-out rates were much lower. The high drop-out rate in large statin studies enrolling many patients with relatively low LDL-C levels on entry may be due to intolerance of treatment regimens. In contrast, in the only other major clinical end-point trial enrolling coronary heart disease patients with a low baseline LDL-C level, which used gemfibrozil, the drop-out rate for the entire 5 years was 2.3%.7 Coronary events were reduced with no change in LDL-C level.

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