March 20, 2006

March 20, 2006 (Atlanta) — A combination of the cholesterol-lowering drugs ezetimibe and simvastatin is more effective at lowering C-reactive protein (CRP) levels than simvastatin alone, a post-hoc analysis of 3 randomized, placebo-controlled, double-blind studies suggests.

A second study showed that ezetimibe/simvastatin was better than atorvastatin in lowering CRP, low-density lipoprotein (LDL) cholesterol, and apolipoprotein (ApoB) levels.

"Ezetimibe/simvastatin provided enhanced lipid regulation and anti-inflammatory effects compared to simvastatin or atorvastatin alone," said Christie M. Ballantyne, MD, associate chief and professor of medicine in the section of atherosclerosis and lipoprotein research at Baylor College of Medicine in Houston, Texas.

Dr. Ballantyne presented both studies here at the 55th annual scientific session of the American College of Cardiology (ACC).

The first pooled analysis used data from 3 randomized, placebo-controlled trials that enrolled 3083 patients with hypercholesterolemia. In each of the studies, patients discontinued therapy for 4 to 6 weeks and then were randomized to placebo, ezetimibe (10 mg), ezetimibe/simvastatin (10/10, 20, 40, 80 mg), or simvastatin (10, 20, 40, 80 mg) for 12 weeks. Ezetimibe/simvastatin is sold as Vytorin.

Overall results, which were pooled across the dose range, showed that CRP levels decreased 31% from baseline for patients receiving ezetimibe/simvastatin compared with 14.3% in patients receiving simvastatin (P < .001). Ezetimibe by itself did not significantly reduce levels of CRP, Dr. Ballantyne said.

The pooled data also showed that the combination treatment reduced LDL cholesterol levels by 52.5% while simvastatin lowered LDL cholesterol levels by 38% (P < .001).

The second study was an analysis of the Vytorin Versus Atorvastatin (VYVA) trial, which evaluated 1902 patients with high cholesterol levels who were randomized to either ezetimibe (10 mg)/simvastatin or atorvastatin (at mg-equivalent statin doses — 10, 20, 40, 80). When the data were pooled across all doses, 32.5% of patients receiving ezetimibe/simvastatin achieved LDL cholesterol levels of less than 70 mg/dL and ApoB levels of less than 90 mg/dL compared with 16% of patients receiving atorvastatin alone (P < .001).

Also, 20.7% of patients receiving ezetimibe/simvastatin achieved an LDL cholesterol level of less than 70 mg/dL and a CRP level of less than 2 mg/L compared with 9.8% of patients receiving atorvastatin (P < .001).

All of the drugs were well tolerated.

James H. Stein, MD, cochair of the scientific program committee for the ACC meeting and an associate professor of medicine at the University of Wisconsin Medical School in Madison, told Medscape that while interesting, the results will need to be confirmed in additional, prospective studies before changing clinical practice.

ACC 55th Annual Scientific Session: Abstracts 808-5 and 981-194. Presented March 13, 2006.

Reviewed by Ariana Del Negro

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