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Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial.
J Cardiovasc Med (Hagerstown) 2008; 9(7):688-93JC

Abstract

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.

Authors+Show Affiliations

Department of Medicine, Faculty of Medicine, Kuwait University, Division of Cardiology, Mubarak Al-Kabeer Hospital, Jabriya, Kuwait.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18545068

Citation

Zubaid, Mohammad, et al. "Effect of Ezetimibe Coadministration With Simvastatin in a Middle Eastern Population: a Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Trial." Journal of Cardiovascular Medicine (Hagerstown, Md.), vol. 9, no. 7, 2008, pp. 688-93.
Zubaid M, Shakir DK, Bazargani N, et al. Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. J Cardiovasc Med (Hagerstown). 2008;9(7):688-93.
Zubaid, M., Shakir, D. K., Bazargani, N., Binbrek, A., Gopal, R., Al-Tamimi, O., & Bakir, S. (2008). Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. Journal of Cardiovascular Medicine (Hagerstown, Md.), 9(7), pp. 688-93. doi:10.2459/JCM.0b013e3282f3a1b1.
Zubaid M, et al. Effect of Ezetimibe Coadministration With Simvastatin in a Middle Eastern Population: a Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Trial. J Cardiovasc Med (Hagerstown). 2008;9(7):688-93. PubMed PMID: 18545068.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of ezetimibe coadministration with simvastatin in a Middle Eastern population: a prospective, multicentre, randomized, double-blind, placebo-controlled trial. AU - Zubaid,Mohammad, AU - Shakir,Douraid K, AU - Bazargani,Nooshin, AU - Binbrek,Azan, AU - Gopal,Raj, AU - Al-Tamimi,Omar, AU - Bakir,Sherif, PY - 2008/6/12/pubmed PY - 2008/10/31/medline PY - 2008/6/12/entrez SP - 688 EP - 93 JF - Journal of cardiovascular medicine (Hagerstown, Md.) JO - J Cardiovasc Med (Hagerstown) VL - 9 IS - 7 N2 - 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. SN - 1558-2027 UR - https://www.unboundmedicine.com/medline/citation/18545068/Effect_of_ezetimibe_coadministration_with_simvastatin_in_a_Middle_Eastern_population:_a_prospective_multicentre_randomized_double_blind_placebo_controlled_trial_ L2 - http://Insights.ovid.com/pubmed?pmid=18545068 DB - PRIME DP - Unbound Medicine ER -