Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis

摘要

Background Previous systematic reviews (2008; 2016) concluded similarity in outcomes between brand-name and generic drugs in cardiology, but they included >= 50% comparative bioavailability studies, not designed or powered to detect a difference in efficacy or safety between drug types. We aimed to summarise best-evidence regarding the effectiveness and safety of generic versus brand-name drugs used in cardiology. Methods For this systematic review of the literature, scientific databases (MEDLINE and EMBASE) were searched from January 1984 to October 2018. Original research reports comparing the clinical impact of brand-name versus generic cardiovascular drugs on humans treated in a real-life setting, were selected. Meta-analyses and subgroup analyses were performed. Heterogeneity (I-2) and risk of bias were tested. Results Among the 3148 screened abstracts, 72 met the inclusion criteria (n >= 1,000,000 patients, mean age 65 +/- 10 years; 42% women). A total of 60% of studies showed no difference between drug types, while 26% concluded that the brand-name drug was more effective or safe, 13% were inconclusive and only 1% concluded that generics did better. The overall crude risk ratio of all-cause hospital visits for generic versus brand-name drug was 1.14 (95% confidence interval: 1.06-1.23; I-2: 98%), while it was 1.05 (0.98-1.14; I-2: 68%) for cardiovascular hospital visits. The crude risk ratio was not statistically significant for randomised controlled trials only (n = 4; 0.92 [0.63-1.34], I-2: 35%). Conclusion The crude risk of hospital visits was higher for patients exposed to generic compared to brand-name cardiovascular drugs. However, the evidence is insufficient and too heterogeneous to draw any firm conclusion regarding the effectiveness and safety of generic drugs in cardiology.