Jacinthe Leclerc1,2,3, Magalie Thibault4, Jennifer Midiani Gonella4,5, Claudia Beaudoin6,7, John Sampalis8. 1. Department of Nursing, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Local 4849, Santé, Trois-Rivières, QC, G9A 5H7, Canada. Jacinthe.leclerc@uqtr.ca. 2. Department of Surgery, McGill University, Montreal, Canada. Jacinthe.leclerc@uqtr.ca. 3. Bureau d'information et d'études en Santé des Populations, Institut National de Santé Publique du Québec, Quebec City, Canada. Jacinthe.leclerc@uqtr.ca. 4. Department of Nursing, Université du Québec à Trois-Rivières, 3351, boul. des Forges, C.P. 500, Local 4849, Santé, Trois-Rivières, QC, G9A 5H7, Canada. 5. Faculty of Nursing, Universidade de Sao Paulo, Ribeirao Preto, Brazil. 6. Bureau d'information et d'études en Santé des Populations, Institut National de Santé Publique du Québec, Quebec City, Canada. 7. Faculty of Medicine, Université Laval, Quebec City, Canada. 8. Department of Surgery, McGill University, Montreal, Canada.
Abstract
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 (I2) 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; I2: 98%), while it was 1.05 (0.98-1.14; I2: 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], I2: 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.
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 (I2) 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; I2: 98%), while it was 1.05 (0.98-1.14; I2: 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], I2: 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.
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