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Clinical Equivalence of Generic and Brand-Name Drugs Used in Cardiovascular Disease:  A Systematic Review and Meta-analysis

Aaron S. Kesselheim, MD, JD, MPH; Alexander S. Misono, BA; Joy L. Lee, BA; Margaret R. Stedman, MPH; M. Alan Brookhart, PhD; Niteesh K. Choudhry, MD, PhD; William H. Shrank, MD, MSHS
JAMA. 2008;300(21):2514-2526. doi:10.1001/jama.2008.758.
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Published online

Context Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs.

Objectives To summarize clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue.

Data Sources Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008.

Study Selection Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution.

Data Extraction We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral.

Results We identified 47 articles covering 9 subclasses of cardiovascular medications, of which 38 (81%) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100%) of β-blockers, 10 of 11 RCTs (91%) of diuretics, 5 of 7 RCTs (71%) of calcium channel blockers, 3 of 3 RCTs (100%) of antiplatelet agents, 2 of 2 RCTs (100%) of statins, 1 of 1 RCT (100%) of angiotensin-converting enzyme inhibitors, and 1 of 1 RCT (100%) of α-blockers. Among narrow therapeutic index drugs, clinical equivalence was reported in 1 of 1 RCT (100%) of class 1 antiarrhythmic agents and 5 of 5 RCTs (100%) of warfarin. Aggregate effect size (n = 837) was −0.03 (95% confidence interval, −0.15 to 0.08), indicating no evidence of superiority of brand-name to generic drugs. Among 43 editorials, 23 (53%) expressed a negative view of generic drug substitution.

Conclusions Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.

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Figure 1. Study Selection
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NTI indicates narrow therapeutic index; WTI, wide therapeutic index.

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Figure 2. Drug Class and Aggregate Meta-analyses of Trials Comparing Generic and Brand-Name Drugs Used in Cardiovascular Disease
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ACE indicates angiotensin-converting enzyme; CI, confidence interval.

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