1. Effect of coadministration of ezetimibe and simvastatin on high-sensitivity C-reactive protein
- Author
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Sager, Philip T., Melani, Lorenzo, Lipka, Leslie, Strony, John, Yang, Bo, Suresh, Ramachandran, and Veltri, Enrico
- Subjects
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C-reactive protein , *HYPERCHOLESTEREMIA , *ANTI-inflammatory agents , *THERAPEUTICS - Abstract
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 ≥145 and ≤250 mg/dl and triglycerides ≤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. [Copyright &y& Elsevier]
- Published
- 2003
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