Generic versus brand-name cardiovascular drugs: a remarkable update

Despite a significantly lower cost than their brand-name counterparts, generic medicines market share does not exceed 50% of the market volume in many developed countries (1]. Indeed, every clinician is repeatedly exposed to anecdotal evidence from patients, colleagues, and of course company representatives, claiming that generic drugs are not as effective and/or safe as their branded counterparts [2]. In the cardiovascular context, such claims are supported by an alleged scarcity of randomized evidence, especially on antiplatelet agents, ACE inhibitors and statins. Last year, we were also exposed to such claims during a course in which general practitioners were warned against generics, and we immediately felt the need to check the literature. We made our best, but we were able to find only one meta-analysis of randomized trials (RCTs) that evaluated the clinical equivalence of more than one generic and branded cardiovascular drug [3]. Also, the meta-analysis was rigorously made but was published in 2008, combined only efficacy outcomes, included only 50, 23 and 71 subjects in the evaluation of antiplatelet agents, ACE inhibitors and statins, respectively, and most of these patients had been followed for less than two days [3]. An easy victory for company representatives, on drugs that have combined sales which exceed $100 billion yearly and dominate the cardiovascular pharmaceutical market [4, 5]. We thus felt the urgency of updating and expanding the randomized evidence on the topic and, in collaboration with other metaanalysts from several research centers, we carried out a meta-analysis of RCTs comparing the efficacy and adverse events, either serious or mild/moderate, of all generic versus brandname cardiovascular drugs. This meta-analysis has just been published in the European Journal of Epidemiology [6]. Given the seriousness of the topic and the potential implications for the global pharmaceutical market, we feel that the findings are worthy of attention from the public health community.