Effect of coadministration of ezetimibe and simvastatin on high-sensitivity C-reactive protein.

Author(s): Sager PT, Melani L, Lipka L, Strony J, Yang B, Suresh R, Veltri E, Ezetimibe Study Group

Affiliation(s): Schering-Plough Research Institute, Kenilworth, New Jersey 07033-1300, USA. Philip.Sager@spcorp.com

Publication date & source: 2003-12-15, Am J Cardiol., 92(12):1414-8.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

This study assessed the effect of ezetimibe coadministered with simvastatin on high-sensitivity C-reactive protein (hs-CRP) in patients with primary hypercholesterolemia. After dietary stabilization, a 2- to 12-week washout period, and a 4-week, single-blind, placebo lead-in period, patients with baseline low-density lipoprotein cholesterol > or =145 and < or =250 mg/dl and triglycerides < or =350 mg/dl were randomized to one of these daily treatments for 12 consecutive weeks: ezetimibe 10 mg; simvastatin monotherapy (10, 20, 40, or 80 mg); ezetimibe 10 mg plus simvastatin (10, 20, 40, or 80 mg); or placebo. The primary analysis was the change in hs-CRP for the pooled ezetimibe plus simvastatin versus simvastatin monotherapy groups. Ezetimibe plus simvastatin significantly reduced median hs-CRP levels compared with simvastatin monotherapy (-34.8% vs -18.2%, p<0.01), and incremental reductions were observed at each simvastatin dose level. Combination therapy-induced significant changes in individual lipid parameters did not explain the observed decreases in hs-CRP. Thus, ezetimibe coadministered with simvastatin resulted in significant incremental decreases in hs-CRP, possibly consistent with an additional anti-inflammatory effect compared with simvastatin monotherapy.