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Branded Versus Generic Clopidogrel in Cardiovascular Diseases: A Systematic Review

Caldeira, Daniel MD*; Fernandes, Ricardo M. MD*; Costa, João MD, PhD*; David, Cláudio MD*; Sampaio, Cristina MD, PhD*,†; Ferreira, Joaquim J. MD, PhD*,†

Journal of Cardiovascular Pharmacology: April 2013 - Volume 61 - Issue 4 - p 277–282
doi: 10.1097/FJC.0b013e31827e5c60
Original Article

Abstract: In the United States, patent for branded Plavix has recently expired. Some studies have compared branded and generic clopidogrel in terms of pharmacokinetic parameters in healthy volunteers, but data on patients and clinical outcomes are scarce.

We aimed to review efficacy and safety data from studies comparing Plavix with generic clopidogrel in patients with cardiovascular disease.

Electronic databases were searched (from inception to May 2012) for prospective studies evaluating branded versus generic clopidogrel in patients with cardiovascular diseases.

Studies' characteristics and data estimates were retrieved. Pooled risk ratio (RR) and 95% confidence intervals (95% CIs) were estimated through a random-effects model.

Three studies evaluating 760 patients were included: 2 randomized controlled trials and 1 cohort study. The RR for major cardiovascular events was 1.01 (95% CI, 0.67–1.52). Incidence of adverse events was similar between Plavix and generic (RR 0.85; 95% CI, 0.49–1.48). The risks of mortality, bleeding, and drug discontinuation were also not different between groups.

There are a limited number of studies comparing Plavix and generic clopidogrel in patients with cardiovascular diseases and reporting hard clinical end points. The available evidence is therefore limited and does not support the existence of differences in efficacy or safety between branded and generic clopidogrel.

*Laboratory of Clinical Pharmacology, Faculty of Medicine, University of Lisbon, Lisbon, Portugal

Neurological Clinical Research Unit, Instituto de Medicina Molecular, Lisbon, Portugal.

Reprints: Dr Daniel Caldeira, MD, Laboratorio de Farmacologia Clinica e Terapeutica, Faculdade de Medicina da Universidade de Lisboa, Av. Prof. Egas Moniz, 1649-028 Lisboa, Portugal (e-mail: dgcaldeira@hotmail.com).

The authors have no funding or conflicts of interest to disclose.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcvp.org).

Received October 22, 2013

Accepted November 15, 2012

© 2013 Lippincott Williams & Wilkins, Inc.