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Questions About Vytorin and Trial Sponsors' Conduct

Mike Mitka

JAMA. 2008;299(8):885-887.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

A clinical trial testing Vytorin, a combination of two anticholesterol drugs (ezetimibe and simvastatin), is embroiled in controversy. (Photo credit: Merck/Schering-Plough Pharmaceuticals)

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 . . . [Full Text of this Article]

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