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Merck/Schering-Plough Zetia-statin combo data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Ezetimibe 10 mg add-on therapy with pravastatin (Bristol-Myers Squibb's Pravacol) shows 13% greater reduction in LDL-C than pravastatin alone (37.7% for the combo vs. 24.3% for pravastatin) in a 538-patient study, Merck and partner Schering-Plough report May 9 at the World Congress of Cardiology in Sydney, Australia. A 548-patient study of add-on therapy with lovastatin (Merck's Mevacor) found a 14% greater reduction for the combo (39% vs. 24.7%). The two Phase III trials are included in a pending NDA for Zetia monotherapy and combo therapy, along with Phase III combo trials with simvastatin (Merck's Zocor), atorvastatin (Pfizer's Lipitor), and a study including a variety of statins (Pharmaceutical Approvals Monthly, April 2002, p. 21). FDA action is expected by year-en

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