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With the release of the ENHANCE trial, public attention has focused once again on the clinical role of ezetimibe, the wisdom of approving drugs based on their effect on cholesterol, the impact of marketing, the ethical behavior of investigators and pharmaceutical companies, and the validity of the central dogma about lowering cholesterol.
In the U.S., ezetimibe was introduced in October 2002. It was the first in its class to be approved, and its approval was predicated on its ability to lower cholesterol. ENHANCE, initiated in August 2002 by Merck and Schering-Plough (the manufacturers of the study drugs), was intended to show that combination therapy with a statin plus ezetimibe has a favorable effect on the progression of atherosclerosis.
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