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Use of generics in cardiovascular diseases Posted 08/01/2016

Researchers from Italy and the US carried out a meta-analysis with the aim of comparing the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines [1].

The authors searched for randomized controlled trials comparing at least one brand-name drug and at least one of its generic versions. The search was carried out in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register and ClinicalTrials.gov (last update 1 December 2014). Where it was not possible to extract any safety or efficacy outcome from a study, attempts were made to contact the investigators.

Two investigators independently extracted and analysed 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.

Of the 745 papers initially retrieved, 74 randomized trials were included in the analysis. Of those, 53 reported at least one efficacy outcome (overall sample 3,051), 32 measured mild/moderate adverse events (n = 2,407) and 51 evaluated serious adverse events (n = 2,892). Included in the analysis were 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 and -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, eight serious possibly drug-related adverse events were reported. Five events occurred in the 2,074 subjects on generics and three events occurred in the 2,076 subjects on brand-name drugs. The meta-analysis on serious adverse events showed no significant differences between generic and brand-name medicines (Odds Ratio 1.69; 95% CI: 0.40‒7.20).

The authors concluded that 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 healthcare organization about endorsing their wider use.

Conflict of Interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Abstracted by Professor Lamberto Manzoli of the Department of Medicine and Aging Sciences, University of Chieti, Italy and the Regional Health Care Agency of Abruzzo, Pescara, Italy.

Editor’s comment
Readers interested to learn more about the use of generics in cardiovascular diseases are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Statin generics: no differences in efficacy after switching

Readers interested in contributing a research or perspective paper to GaBI Journal– an independent, peer reviewed academic journal – please send us your submission here.

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Reference
1.  Manzoli L, Flacco ME, Boccia S, D'Andrea E, Panic N, Marzuillo C, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2015 Nov 30. [Epub ahead of print]

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