BMJ  2008;336:180-181 (26 January), doi:10.1136/bmj.39468.610775.DB

News

Unreported cholesterol drug data released by company

Jeanne Lenzer

1 New York

The first 150 words of the full text of this article appear below.

The makers of a popular cholesterol lowering drug have posted results of a study showing it was ineffective—but only after a Congressional inquiry was set up to look into why they had not published their results two years after the study was completed.

Merck and Schering-Plough Pharmaceuticals, manufacturers of ezetimibe (Zetia), posted results on their websites earlier this month showing that 356 people treated with ezetimibe (10 mg) plus simvastatin (80 mg) fared no better than 360 who had received simvastatin alone (www.sch-plough.com/schering_plough/news/release.jsp?releaseID=1095943).

The study, known as the ENHANCE (Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia) trial, measured the thickness of carotid artery intima media as its primary end point. Although ezetimibe did cause an additional lowering of cholesterol, plaque progression was worse in the ezetimibe arm.

Ezetimibe, sold singly as Zetia or in combination . . . [Full text of this article]


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