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To the Editor: The IDEAL study¹ is 1 of 4 recent large clinical trials that have examined whether high-dose statins improve outcomes compared with conventional doses. The first 2 trials (PROVE-IT² and A to Z³) enrolled patients with acute coronary syndromes (ACS), whereas the latter 2 trials (TNT⁴ and IDEAL¹) enrolled patients with stable coronary artery disease. The results from these trials appear to conflict: PROVE-IT and TNT found statistically significant differences, whereas A-to-Z and IDEAL did not. Some of these conflicts may be related to the study designs.

It has become increasingly common for clinical trials to join nonequivalent outcomes into a single composite end point, such as combining mortality with new nonfatal myocardial infarction, revascularization, or rehospitalization.⁵ Indiscriminately combining mortality with other outcomes may lead to biases related to "competing risk," in which patients who die early in a trial are unable to experience future nonfatal . . . [Full Text of this Article]

Paul S. Chan, MD, MSc
paulchan@umich.edu

Brahmajee K. Nallamothu, MD, MPH; Rodney A. Hayward, MD
VA Center for Practice Management and Outcomes Research
Ann Arbor, Mich

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