Healthy Skepticism Library item: 13517

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Publication type: Journal Article

Lenzer J.
Company’s decision to lengthen lipid lowering trial causes controversy
BMJ 2008 Apr 12; 336:(7648):797
http://www.bmj.com/cgi/content/extract/336/7648/797-a?etoc

Abstract:

The decision to extend enrolment of participants in a lipid lowering trial that was set to come to an end in 2011 because the target for enrolments had already been exceeded is causing controversy.

The delay follows an earlier row about the delayed reporting of the results of another study of the same drug, ezetimibe, which is manufactured jointly by Merck and Schering-Plough and sold singly as Ezetrol in the United Kingdom and as Zetia in the United States, or in combination with simvastatin as Inegy in the UK and Vytorin in the US (BMJ 2008;336:180-1; doi: 10.1136/bmj.39468.610775.DB).

Merck and Schering-Plough published a news release on 28 March stating that they will extend enrolment in IMPROVE-IT (improved reduction of outcomes: vytorin efficacy international trial) to determine whether ezetimibe added to simvastatin “will translate into clinical benefit” compared with simvastatin alone, according to the trial’s chairman, Eugene Braunwald.