Letters Section Editor: Robert M. Golub,
MD, Senior Editor.
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).2- 4 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.
Isley WL. High-Dose Statins in Acute Coronary Syndromes. JAMA. 2005;293(1):36-39. doi:10.1001/jama.293.1.37-b