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

Generic versus brand-name drugs used in cardiovascular diseases: an updated meta-analysis / Manzoli, L; Flacco, Me; Boccia, S; D'Andrea, Elvira; Panic, N; Marzuillo, Carolina; Siliquini, R; Ricciardi, W; Villari, Paolo; Ioannidis, Jp. - In: EUROPEAN JOURNAL OF PUBLIC HEALTH. - ISSN 1101-1262. - ELETTRONICO. - 25 (suppl 3)(2015), pp. 74-75. ((Intervento presentato al convegno 8th European Public Health Conference. Health in Europe – from global to local policies, methods and practices tenutosi a Milan, Italy nel 14 - 17 October 2015.

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

D'ANDREA, ELVIRA;MARZUILLO, CAROLINA;VILLARI, Paolo;
2015

Abstract

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
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11573/908789
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