Clinical Health Updates

Generic and brand-name drugs equally effective for cardiovascular disease

Clinical Question:
Are generic and brand-name drugs equally effective in the treatment of adults with cardiovascular disease?

Bottom Line:
In the management of adult cardiovascular disease, current evidence firmly demonstrates that generic equivalents are as clinically effective as their brand name counterparts, including beta-blockers, diuretics, calcium-channel blockers, antiplatelet agents, statins, angiotensin-converting enzyme (ACE) inhibitors, alpha-blockers, anti-arrhythmic agents, and warfarin. Interestingly, more than half the editorials published in various journals during the same period as this systematic review expressed negative opinions about the value of generic drugs. (LOE = 1a)

Reference:
Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease. A systematic review and meta-analysis. JAMA 2008;300:2514-2526.

Study Design:
Systematic review

Funding:
Government

Setting:
Various (meta-analysis)

Summary:
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. The authors summarized clinical evidence comparing generic and brand-name drugs used in cardiovascular disease and to assess the perspectives of editorialists on this issue. Systematic searches of peer-reviewed publications in MEDLINE, EMBASE, and International Pharmaceutical Abstracts from January 1984 to August 2008. Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution. They 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. They 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 beta-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 alpha-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.