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Ezetimibe Plus Simvastatin Reduces C-Reactive Protein in Patients With High Cholesterol: Presented at ACC

By Ed Susman

CHICAGO, IL -- April 4, 2003 -- Levels of C-reactive protein, a marker of inflammation in the body, can be markedly reduced when patients are treated with the cholesterol-lowering agents simvastatin and ezetimibe, according to a new study.

The results were reported here April 2^nd at the 52^nd Annual Scientific Session of the American College of Cardiology.

"This study was undertaken because while we know that when ezetimibe is co-administered with a statin the lipid profile is significantly improved, . . . we did not know if there was an effect on C-reactive protein," explained researcher Philip Sager, MD, director of cardiac research at Schering Plough Research Institute, Kenilworth, New Jersey.

"What we found in our study," he said, "was that when co-administered with simvastatin, ezetimibe provided significant incremental reductions in low-density lipoprotein [LDL] cholesterol and in [C-reactive protein] levels."

C-reactive protein is considered an emerging risk factor and risk marker for coronary heart disease, said Michael Davidson, MD, associate professor of medicine and director of preventive cardiology at Rush-Presbyterian Hospital-St. Luke's Medical School, Chicago, Illinois. Dr. Davidson was not involved in the study.

The researchers enrolled 668 patients with primary hypercholesterolemia in a randomized, double-blind, placebo-controlled study. Following attempts at recommended diets and a washout period, patients who had a baseline LDL cholesterol of 145 mg/dL to 250 mg/dL and triglyceride levels greater than 350 mg/dL were assigned to 12 consecutive weeks of one of the following: ezetimibe 10 mg/day; simvastatin 10, 20, 40, or 80 mg/day; ezetimibe 10 mg plus simvastatin 10, 20, 40, or 80 mg/day; or placebo. In the study, 55 patients were taking ezetimibe alone, 232 patients were on the various simvastatin doses, 229 patients were on the combination, and 62 patients were given placebo.

Dr. Sager said that when the combinations of ezetimibe and simvastatin were pooled, the researchers observed a 49.9% reduction of LDL cholesterol, compared with a 36.1% reduction in LDL cholesterol for the pooled simvastatin only cohorts. He said that reached statistical significance at the P<0.01 level. He said the combination appeared to be superior to statin alone at each dose level.

They also observed that the levels of C-reactive protein were about halved when the pooled ezetimibe plus simvastatin results were compared with simvastatin alone. The combination produced about a 34.8% reduction, compared with an 18.2% reduction if the statin was used as monotherapy. That reached statistical significance at the P<0.01 level, he said.

The study was supported by Merck/Schering-Plough Pharmaceuticals, a joint venture between Merck & Co., Inc., and Schering-Plough Corporation to develop and market medications in cholesterol management.


[Study title: C-Reactive Protein Is Reduced During Ezetimibe Coadministration With Simvastatin in Patients With Primary Hypercholesterolemia. Abstract: 876-6]

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