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DYSLIPIDEMIA

Reduction in Estimated Risk for Coronary Artery Disease After Use of Ezetimibe with a Statin

Associate Professor, Department of Surgery and Epidemiology and Department of Biostatistics, McGill University; President, JSS Medical Research Inc., Montreal, Québec, Canada

Stéphane Bissonnette, DPH PharmD

Senior Manager of Clinical Research, Merck Frosst/Schering Pharmaceuticals, Kirkland, Québec

Rafik Habib, MD

Director, Centre Cardiovasculaire de Laval, Laval, Québec

Stella Boukas, BA

Director of Clinical Operations, JSS Medical Research Inc.

for the Ezetrol Add-On Investigators^a

Reprints: Dr. Sampalis, 4492 St. Catherine St. West, Westmount, QC H3Z 1R7, Canada, fax 514/934-9913, jsampalis{at}jssresearch.com

BACKGROUND: The aim of lipid-lowering treatment is to reduce the risk for cardiovascular events. Patients not at target lipid levels while on hydroxymethylglutaryl coenzyme A reductase inhibitors (statin) monotherapy are at increased cardiovascular risk.

OBJECTIVE: To describe the impact of coadministration of ezetimibe with a statin on the estimated 10 year risk for coronary artery disease (E-R_CAD) in patients with hypercholesterolemia and above-target low-density lipoprotein cholesterol (LDL-C) levels after statin monotherapy.

METHODS: Post hoc analysis was conducted of a prospective, open-label, single-cohort, multicenter Canadian study of 953 patients who were treated for 6 weeks with ezetimibe 10 mg/day coadministered with their current statin at an unaltered dose. For each patient, E-R_CAD at baseline and at 6 weeks was calculated using the Framingham model. The primary outcome measure of the analysis was the change in E-R_CAD.

RESULTS: A total of 825 patients with data at baseline and 6 weeks were included in the analysis. There were 423 (51.3%) patients with hypertension, 107 (13.0%) with diabetes mellitus but not metabolic syndrome, 160 (19.4%) with metabolic syndrome but not diabetes mellitus, and 235 (28.5%) with both diabetes mellitus and metabolic syndrome. After 6 weeks of ezetimibe coadministration with statin therapy, mean E-R_CAD was reduced by 4.1% from 15.6% to 11.5%, which is equivalent to a 25.3% risk reduction (p < 0.001). Of the 225 (27.3%) patients with high E-R_CAD (20.1%) at baseline, 144 (64.0%) converted to a lower E-R_CAD category (p < 0.001). Patients with both diabetes mellitus and metabolic syndrome experienced the highest mean percent reduction in E-R_CAD of –29.4% (p < 0.001).

CONCLUSIONS: For patients with above-target LDL-C levels while on statin monotherapy, coadministration of ezetimibe with the statin is effective in significantly reducing the E-R_CAD.

Key Words: coronary artery disease risk, diabetes, ezetimibe, hypercholesterolemia, metabolic syndrome

Published Online, July 31, 2007. www.theannals.com, DOI 10.1345/aph.1K140