Braden Manns, MD
Are generic drugs as effective as brand-name drugs for treating cardiovascular disease?
Included studies compared 1 brand-name drug with ≥ 1 generic version for treating cardiovascular disease (i.e., any condition affecting the heart or blood vessels) and reported ≥ 1 clinical efficacy or safety endpoint. Biologic products were excluded. Outcomes included vital signs (e.g., heart rate, blood pressure, and urine output), clinical laboratory studies (e.g., international normalized ratio, low-density lipoprotein, and urine electrolytes), patient morbidity or mortality, and health system use.
MEDLINE, EMBASE/Excerpta Medica, and International Pharmaceutical Abstracts (1984 to Aug 2008) were searched for randomized controlled trials (RCTs) and observational studies published in English. Case studies, qualitative analyses, pharmacoeconomic evaluations, and surveys were excluded. 47 studies (38 RCTs) were included. RCT quality was assessed using the Jadad scale (range 0 to 5, mean 2.4). RCTs with data on means and standard deviations were included in a meta-analysis.
Equivalence based on the outcomes assessed between brand-name drugs and generic versions was reported for β-blockers (7 of 7 RCTs), diuretics (10 of 11 RCTs), calcium-channel blockers (5 of 7 RCTs), antiplatelet agents (3 of 3 RCTs), angiotensin-converting enzyme inhibitors (1 of 1 RCT), statins (2 of 2 RCTs), α-blocker (1 of 1 RCT), antiarrhythmic agents (1 of 1 RCT), and warfarin (5 of 5 RCTs). The aggregate effect size was not significant (Table).
Brand-name drugs used to treat cardiovascular disease are not more effective than generic versions.
Brand-name drugs vs generic versions for cardiovascular disease*
*ACE = angiotensin-converting enzyme; RCT = randomized controlled trial.
†Outcomes included vital signs (e.g., heart rate, blood pressure, and urine output), clinical laboratory studies (e.g., international normalized ratio, low-density lipoprotein, and urine electrolytes), patient morbidity or mortality, and health system use.
Manns B. Review: Brand-name drugs are not more effective than generic versions for treating cardiovascular disease. Ann Intern Med. ;150:JC4–6. doi: 10.7326/0003-4819-150-8-200904210-02006
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Published: Ann Intern Med. 2009;150(8):JC4-6.
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