Author Affiliation: Department of Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio.
For more than a decade, statin drugs have accumulated a remarkable record
of successful clinical trials, demonstrating robust evidence for reduction
in clinical events, including myocardial infarction, stroke, and cardiovascular
death in primary and secondary prevention populations.1-4 Recent
trials have shown that intensive statin therapy is superior to moderate therapy
for reducing morbidity following an acute coronary syndrome (ACS) event5,6 and for slowing the progression of
coronary atherosclerosis.7 Statin trials have
also demonstrated a favorable safety profile with only rare and isolated cases
of serious toxicity.8 Given the spectacular
success of this class of drugs, the failure of a statin clinical trial to
meet its prespecified objective and evidence of an adverse safety profile
are unusual and mandate careful analysis of potential responsible factors.
Nissen SE. High-Dose Statins in Acute Coronary Syndromes: Not Just Lipid Levels. JAMA. 2004;292(11):1365–1367. doi:10.1001/jama.292.11.1365
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