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European Journal of Epidemiology

, Volume 31, Issue 4, pp 351–368

First Online: 30 November 2015Received: 10 August 2015Accepted: 25 November 2015DOI: 10.1007-s10654-015-0104-8

Cite this article as: Manzoli, L., Flacco, M.E., Boccia, S. et al. Eur J Epidemiol 2016 31: 351. doi:10.1007-s10654-015-0104-8

Abstract

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild-moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov last update December 1, 2014. Attempts were made to contact the investigators of all potentially eligible trials. Two investigators 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. We included 74 randomized trials; 53 reported ≥1 efficacy outcome overall sample 3051, 32 measured mild-moderate adverse events n = 2407, and 51 evaluated serious adverse events n = 2892. We included trials assessing ACE inhibitors n = 12, anticoagulants n = 5, antiplatelet agents n = 17, beta-blockers n = 11, calcium channel blockers n = 7; diuretics n = 13; statins n = 6; and others n = 3. For both soft and 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 −0.71; 0.59 for hard outcomes. All but two trials showed non-significant differences in mild-moderate adverse events, and aggregate effect size was 0.07 −0.06; 0.20. Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5-2074 subjects on generics; 3-2076 subjects on brand-name drugs OR 1.69; 95 % CI 0.40–7.20. This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use.

KeywordsGeneric drug Brand-name drug Cardiovascular diseases Meta-analysis Efficacy Safety Lamberto Manzoli and Maria Elena Flacco have equally contributed to the present work.

Electronic supplementary materialThe online version of this article doi:10.1007-s10654-015-0104-8 contains supplementary material, which is available to authorized users.

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Autor: Lamberto Manzoli - Maria Elena Flacco - Stefania Boccia - Elvira D’Andrea - Nikola Panic - Carolina Marzuillo - Roberta 

Fuente: https://link.springer.com/







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