Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial.

Author(s): Zubaid M, Shakir DK, Bazargani N, Binbrek A, Gopal R, Al-Tamimi O, Bakir S

Affiliation(s): aDepartment of Medicine, Faculty of Medicine, Kuwait University, Division of Cardiology, Mubarak Al-Kabeer Hospital, Jabriya, Kuwait bHamad Medical Corporation, Cardiology Department, Qatar cDepartment of Medicine, Faculty of Medicine, WCMC-Q, Doha, Qatar dDubai Hospital, Dubai, UAE eRashid Hospital, Dubai, UAE fAl-Ain Hospital, Al-Ain, UAE gHamad Hospital, Doha, Qatar hQassimi Hospital, Sharjah, UAE.

Publication date & source: 2008-07, J Cardiovasc Med (Hagerstown)., 9(7):688-693.

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OBJECTIVES: To assess the efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolaemia and coronary artery disease (CAD). DESIGN AND SETTING: Prospective, multicentre, randomized, double-blind, placebo-controlled trial conducted in three Middle Eastern countries. PATIENTS: Patients with known CAD, who were being treated with simvastatin 20 mg and had low-density lipoprotein cholesterol (LDL-C) concentrations of 2.6 to 4.1 mmol/l, were randomized to receive daily coadministration of ezetimibe 10 mg or placebo. MAIN OUTCOME MEASURES: The primary outcome was percentage reduction of LDL-C after 6 weeks of randomization. Secondary endpoints included number of patients who achieved National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C level and safety and tolerability. RESULTS: We enrolled 144 patients of whom 120 had blood available for final analysis. The coadministration of ezetimibe with ongoing simvastatin therapy resulted in a statistically significant additional reduction in LDL-C concentration as compared with simvastatin monotherapy (-26.7 versus -9.1%, respectively; total additional reduction of 17.6%, P < 0.0001). More patients in the ezetimibe and simvastatin group achieved NCEP ATP III LDL-C target levels than in the simvastatin monotherapy group (70 versus 33%, respectively; P = 0.0001). The coadministration of ezetimibe with simvastatin was well tolerated with a safety profile similar to that of simvastatin monotherapy. CONCLUSION: When coadministered with simvastatin therapy, ezetimibe resulted in significant additional reduction in LDL-C and enabled more patients to achieve NCEP ATP III LDL-C target levels. This was achieved safely and with excellent tolerability.