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Eur J Epidemiol. 2016 Apr;31(4):351-68. doi: 10.1007/s10654-015-0104-8. Epub 2015 Nov 30.

Generic versus brand-name drugs used in cardiovascular diseases.

Author information

1
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013, Chieti, Italy. lmanzoli@post.harvard.edu.
2
Regional Health Care Agency of Abruzzo, Via Attilio Monti 9, Pescara, Italy. lmanzoli@post.harvard.edu.
3
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013, Chieti, Italy.
4
Regional Health Care Agency of Abruzzo, Via Attilio Monti 9, Pescara, Italy.
5
Institute of Public Health, Catholic University of Rome, Largo Francesco Vito, 1, 00168, Rome, Italy.
6
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Viale Regina Elena 324, 00161, Rome, Italy.
7
Department of Public Health Sciences, University of Turin, Via Santena 5bis, 10126, Turin, Italy.
8
Italian National Institute of Health, Via Regina Elena 299, 00161, Rome, Italy.
9
Stanford Prevention Research Center, Department of Medicine and Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.
10
Department of Statistics, Stanford University School of Humanities and Sciences, Stanford, CA, USA.
11
Meta-Research Innovation Center at Stanford (METRICS), Stanford, CA, USA.

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.

KEYWORDS:

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

PMID:
26620809
PMCID:
PMC4877434
DOI:
10.1007/s10654-015-0104-8
[Indexed for MEDLINE]
Free PMC Article

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