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: firstname.lastname@example.org).
The authors have no funding or conflicts of interest to disclose.
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Received October 22, 2013
Accepted November 15, 2012