Generic versus brand-name drugs used in cardiovascular diseases

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

Bioequivalence study of 2.5 mg film-coated bisoprolol tablets in healthy volunteers

“…A positive study result is similar to the analogous bioequivalence study of Bisocard ® 10 mg film-coated tablets [22]. It is also consistent with the recent meta-analysis that confirmed the efficacy and safety of generic drugs used in the treatment of cardiovascular diseases [23].…”

Visualizing nationwide variation in Medicare Part D prescribing patterns

“…Our findings complement reports showing considerable geographic variation in both claims volume [80] and cost [4] across the United States. Potential contributing factors to such variation [29,[81][82][83], include suboptimal care or health services delivery inefficiencies [84,85], and regional differences in prescriptions for branded drugs compared to generic counterparts [86][87][88][89]. Our analysis of metropolitan areas, adjusted to reduce the effect of population density, also reveals considerable residual variation in prescribing patterns, with up to ten-fold variations for both individual drugs and drug classes.…”

Approaches to Personalized Therapy

“…При выборе медикаментов врачи не всегда учитывают данные исследований, свидетельствующих, что более дешевые дженерики, созданные в соответствии с международными требованиями к качеству препаратов, не только не уступают оригинальным препаратам, но и дают лучшие результаты вследствие большей приверженности [15].…”