The Pharmaceutical Journal
Vol 269 No 7214 p313
7 September 2002

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New combination preparation could be the future for lipid management

A new combination preparation incorporating the novel cholesterol absorption inhibitor ezetimibe and simvastatin is being developed in a joint collaboration between Merck Sharp & Dohme and Schering-Plough Corp.

Unlike statins, which inhibit endogenous synthesis of cholesterol, ezetimibe inhibits cholesterol absorption in the digestive tract. Ezetimibe monotherapy has been shown in clinical trials to reduce cholesterol by a further 21 per cent when used in combination with a statin.

Ezetimibe is currently being reviewed by the United States Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products. MSD declined to comment on the timing of a license application for ezetimibe in the United Kingdom. However, Dr Chris Allen, medical director at MSD, confirmed at the European Society of Cardiology congress in Berlin this week that a combination preparation containing both ezetimibe and simvastatin was being developed, in addition to ezetimibe monotherapy. He told The Journal: "We are in the phase III programme and we are testing a variety of doses of simvastatin with ezetimibe."

He added that production of both drugs as monotherapies was likely to continue in parallel with any combination drug, even though simvastatin is expected to come off patent next year. "Monotherapy does have a clinical role," he said. "Ezetimibe monotherapy could be efficacious in some patients that may not want to or who cannot take statins."

Dr Allen and colleagues who were involved in the ezetimibe-statin clinical trials, presented new analyses of previous data showing that reductions in low-density lipoprotein cholesterol produced by the combination treatment were reproducible regardless of which statin was used, and were consistent across different subgroups of patients, including the elderly, diabetics, men and women.