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PJ Online homeThe Pharmaceutical Journal
Vol 273 No 7317 p375
18 September 2004

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No advantage over statins for ezetimibe, says DTB

Ezetimibe (Ezetrol) offers no compelling clinical advantage over, and should not replace, a statin used by itself for routine cholesterol-lowering, according to the Drug and Therapeutics Bulletin (2004;42:65).

Ezetimibe, an inhibitor of cholesterol absorption, is licensed for use with a statin in patients who are not controlled with a statin alone, and for use on its own if a statin is inappropriate or not tolerated.

Clinical trials have shown that reduction in low density lipoprotein (LDL)-cholesterol with ezetimibe plus the lowest dose of statin is similar to that with the highest dose of statin taken alone. The bulletin says that adding ezetimibe to a statin is one way of further reducing cholesterol but this strategy is no safer and is much more expensive than maximising the dose of a statin. It also points out that the effects of ezetimibe, alone or with a statin, on cardiovascular morbidity and mortality are not known, since clinical trials have used surrogate markers of efficacy, such as reduction in LDL-cholesterol.

In response, Merck Sharp & Dohme and Schering-Plough, which jointly market ezetimibe, note that cholesterol targets are becoming increasingly aggressive, with new guidelines expected to recommend a total cholesterol of <4mmol/L. Yet 50 per cent of patients treated with a statin alone are not reaching the current targets, demonstrating the need for additional lipid lowering therapies. The companies add that many patients and doctors are reluctant to use higher doses of statins.

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