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A Case Study of Single‐Pill Combination Therapy: The Ezetimibe/Simvastatin Combination for Treatment of Hyperlipidemia
Author(s) -
Huang Xianhai,
Chen David Y.K.
Publication year - 2012
Publication title -
chemmedchem
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.817
H-Index - 100
eISSN - 1860-7187
pISSN - 1860-7179
DOI - 10.1002/cmdc.201200287
Subject(s) - ezetimibe , medicine , combination therapy , pill , simvastatin , clinical trial , intensive care medicine , pharmacology , statin
In recent years, combination therapy has received growing popularity as a powerful therapeutic tactic for the treatment of diseases. The justifications and benefits of combination therapy are far‐reaching, including but not limited to addressing unmet medical needs such as cancer, malaria, and HIV/AIDS, improved clinical efficacy and safety with reduced dosage of a single medication, understanding the underlying science of the disease, alleviating pharmaco‐economic impacts, and better drug life‐cycle management. Using the ezetimibe/simvastatin combination therapy as a case study, a comprehensive overview of the successful discovery and development of the single‐pill combination, Vytorin, is presented in this review. A cursory introduction to combination therapy and the rationale for the ezetimibe/simvastatin combination for the treatment of hyperlipidemia provides an instructive entry point. The discovery and mode of action of simvastatin and ezetimibe monotherapies set the scene for a detailed discussion on the discovery and development of Vytorin, with emphasis on bioequivalency studies, clinical efficacy and safety profile studies, and the economic consequences of the single‐pill combination therapy. Large‐scale outcome clinical trials are also discussed to demonstrate the long‐term effects of Vytorin.