Skip Navigation

This Article
Right arrow FREE Full Text (PDF) Freely available
Right arrow References
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Disclaimer
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Ballantyne, C.M.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Ballantyne, C.M.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?


Ezetimibe: efficacy and safety in clinical trials

C.M. Ballantyne*

Center for Cardiovascular Disease Prevention, Methodist DeBakey Heart Center, Baylor College of Medicine, Texas, U.S.A.

* Correspondance: Christie Ballantyne, MD, Section of Atherosclerosis and Lipoprotein Research, Baylor College of Medicine, 6565 Fannin Street, M.S. A-601, Suite A654B, Houston, Texas 77030, U.S.A.

Abstract

Aims: To review clinical trials establishing the efficacy and safety of ezetimibe 10 mg once daily, as monotherapy and co-administered with statins, for the treatment of hypercholesterolemia. Methods and results: As monotherapy, ezetimibe produced reductions in low-density lipoprotein cholesterol (LDL-C) of approximately 18% ( compared with placebo). As add-on therapy for patients who failed to meet target reductions with statin monotherapy, the addition of ezetimibe produced a 21·4% additional reduction in LDL-C compared with statin monotherapy (). Addition of ezetimibe to statin therapy also significantly improved high-density lipoprotein cholesterol and triglyceride levels compared with statin monotherapy (, , respectively). In four studies in which ezetimibe 10 mg was co-administered with simvastatin, atorvastatin, pravastatin, or lovastatin at different dosages, reductions in LDL-C levels with co-administration were significantly greater than those obtained with the corresponding statin monotherapy dose. Ezetimibe plus 10 mg of simvastatin or atorvastatin produced LDL-C reductions comparable to 80 mg of the respective statin monotherapy. In all the clinical trials, ezetimibe was well tolerated, with a safety profile comparable to that of statin monotherapy and to that of placebo. Drug-drug interactions have not been observed when ezetimibe is given concomitantly with statins, fenofibrate, oral contraceptives, or a number of other commonly administered drugs. Conclusion: In the phase II and phase III clinical trial development program, ezetimibe has been shown to be an effective and safe new option for treating hypercholesterolemia even in difficult-to-treat populations such as homozygous and heterozygous familial hypercholesterolemia and sitosterolemia.

Key Words: Cholesterol-lowering drugs • clinical trials • ezetimibe • low-density lipoprotein cholesterol • hyperlipidemia


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 CirculationHome page
E. Bruckert, P. Giral, and P. Tellier
Perspectives in Cholesterol-Lowering Therapy: The Role of Ezetimibe, a New Selective Inhibitor of Intestinal Cholesterol Absorption
Circulation, July 1, 2003; 107(25): 3124 - 3128.
[Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.