The long-anticipated release of results from a clinical trial designed to evaluate a combination therapy intended to prevent progression of atherosclerosis—results which, in fact, found no beneficial effect—has riled the cardiology community, led to lawsuit filings,
and seized the attention of government regulators.
The trial pitted Vytorin, a combination of ezetimibe (Zetia,
Schering-Plough Corporation, Kenilworth, NJ) and simvastatin (Zocor,
Merck & Co Inc, Whitehouse Station, NJ), against simvastatin alone in patients with heterozygous familial hypercholesterolemia. After 2 years, the investigators found no statistically significant difference between treatment groups on the primary end point of mean change in the carotid intima-media thickness—a surrogate marker of atherosclerosis.
An analysis of a secondary end point, the reduction of low-density lipoprotein cholesterol (LDL-C), found that ezetimibe/simvastatin achieved a significantly greater decrease in LDL-C compared with simvastatin alone.
Mitka M. Controversies Surround Heart Drug Study. JAMA. 2008;299(8):885-887. doi:10.1001/jama.299.8.885