Generic versus brand-name drugs used in cardiovascular diseases: an updated meta-analysis

Background Besides bioequivalence, the crucial assumption of equal health benefits of generics and brand-name cardiovascular drugs is based upon a single meta-analyses, published in 2008, combining only efficacy outcomes, and basing its conclusions on antiplatelet agents, ACE inhibitors and statins upon 50, 23 and 71 subjects, respectively. Such a scarcity of randomized evidence is typically used to support periodic claims of a superior clinical effect of brand-name vs generic drugs. We performed a meta-analysis to compare the efficacy and safety of generic versus brand-name cardiovascular drugs. Methods We searched electronic databases and ClinicalTrials.gov (up to 01.12.2014). We included only randomized trials reporting >=1 efficacy/safety outcome. We independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. Results We included 74 RCTs; 53 reported >=1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 52 evaluated serious adverse events (n = 2952). 12 RCTs assessed ACE inhibitors, 5 anticoagulants, 17 antiplatelet agents, 11 beta-blockers, 7 calcium channel blockers, 13 diuretics, 6 statins, 3 other drugs. For soft or hard efficacy outcomes, 100% of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95%CI: 0.05; 0.08) for soft outcomes; 0.06 (95%CI: 0.71; 0.59) for hard outcomes. All but 2 trials showed non-significant differences in mild/moderate adverse events (aggregate effect size 0.07; 95%CI: 0.06; 0.20). Comparableresults were observed for serious adverse events and for each drug class and in each stratified meta-analysis. Conclusions This meta-analysis substantially strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Key messages Generic and brand-name cardiovascular drugs have similar efficacy and safety Physicians should be reassured about prescribing generic cardiovascular drugs to patients, and health care organizations about endorsing their wider use