Generic versus brand-name drugs used in cardiovascular diseases

Lamberto Manzoli, Maria Elena Flacco, Stefania Boccia, Elvira D’Andrea, Nikola Panic, Carolina Marzuillo, Roberta Siliquini, Walter Ricciardi, Paolo Villari, John P A Ioannidis

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1-18
Number of pages18
JournalEuropean Journal of Epidemiology
DOIs
Publication statusAccepted/In press - Nov 30 2015

Keywords

  • Brand-name drug
  • Cardiovascular diseases
  • Efficacy
  • Generic drug
  • Meta-analysis
  • Safety

ASJC Scopus subject areas

  • Epidemiology

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  • Cite this

    Manzoli, L., Flacco, M. E., Boccia, S., D’Andrea, E., Panic, N., Marzuillo, C., Siliquini, R., Ricciardi, W., Villari, P., & Ioannidis, J. P. A. (Accepted/In press). Generic versus brand-name drugs used in cardiovascular diseases. European Journal of Epidemiology, 1-18. https://doi.org/10.1007/s10654-015-0104-8