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Ezetimibe Plus Simvastatin Reduces C-Reactive Protein Levels: Presented at AHA

By Charlene Laino

ORLANDO, FL -- November 14, 2003 -- Combination therapy with the cholesterol-lowering agents simvastatin and ezetimibe significantly reduced both low-density lipoprotein (LDL) cholesterol and levels of C-reactive protein (CRP), a marker of inflammation in the body, a new study shows.

Leslie Lipka, MD, PhD, Schering Plough Research Institute, Kenilworth, New Jersey, United States, reported the results here on November 12^th at the American Heart Association's Scientific Sessions 2003.

While it is known that adding ezetimibe to a statin further reduces LDL cholesterol and improves the lipid profile as compared with a statin alone, the researchers aimed to determine if there was a beneficial effect on CRP levels as well.

The answer was 'yes'. "When co-administered with simvastatin, ezetimibe provided significant incremental reductions in LDL cholesterol and in CRP levels," Dr. Lipka explained.

The researchers pooled data from two similarly designed randomized, double-blinded, placebo-controlled trials that enrolled a total of 1,113 patients with primary hypercholesterolemia. 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 treatment with one of the following regimens: ezetimibe 10 mg/d; simvastatin 10, 20, 40, or 80 mg/d; ezetimibe 10 mg plus simvastatin 10, 20, 40, or 80 mg/d; or placebo. In the study, 109 patients were taking ezetimibe alone, 443 patients were on the various simvastatin doses, 443 patients were on the combination, and 118 patients were given placebo.

By the end of the study period, LDL cholesterol dropped 52% in the patients given the combination of ezetimibe and simvastatin, compared with 37% in those given the statin alone (P < .01), Dr. Lipka reported.

Also, the levels of CRP were cut in half when the pooled ezetimibe-plus-simvastatin results were compared with simvastatin alone, he said. The combination produced about a 33.3% reduction in CRP levels, compared with a 14.3% reduction if the statin was used alone. That reached statistical significance at the P < .01 level, she said.

There was a significant dose-response relationship, Dr. Lipka added, with greater CRP reductions at each simvastatin dose tested. CRP reductions by ezetimibe plus 10 mg of simvastatin were comparable with monotherapy with 80 mg of simvastatin, the study showed.

Merck/Schering-Plough Pharmaceuticals, a joint venture of Merck & Co., Inc., and Schering-Plough Corporation that develops and markets cholesterol-lowering medications, funded the trial.


[Study title: The Effects of Ezetimibe Co-Administered With Simvastatin on C-Reactive Protein From a Large Cohort of Hypercholesterolemic Patients.]

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