In This Edition
- Generic vs. brand-name drugs.
- Rapid-response teams and mortality.
- A new prediction rule for mortality in acute pancreatitis.
- Viral causes of community-acquired pneumonia.
- Intensive insulin therapy in the ICU.
- New preoperative and intraoperative risk factors.
- Timing of ICU feedings and mortality.
- Aspirin as primary prevention in diabetics.
Clinical question: Is there a clinical risk when substituting generic drugs for brand-name drugs in the treatment of cardiovascular disease?
Background: Spending on healthcare in the U.S. has reached critical levels. Increasing prescription drug costs make up a large portion of healthcare expenditures. The high cost of medicines directly affect adherence to treatment regimens and contribute to poor health outcomes. Cardiovascular drugs make up the largest portion of outpatient prescription drug spending.
Study design: Systematic review of relevant articles with a meta-analysis performed to determine an aggregate effect size.
Setting: Multiple locations and varied patient populations.
Synopsis: A total of 47 articles were included in the review, of which 38 were randomized controlled trials (RCTs). The studies measured both clinical efficacy and safety end points. More than half the articles were published prior to 2000. Clinical equivalence was noted in all seven beta-blocker RCTs; 10 of 11 diuretic RCTs; five of seven calcium-channel-blocker RCTs; all three antiplatelet-agent RCTs (clopidogrel, enteric-coated aspirin); two statin RCTs; one ACE-inhibitor RCT; and one alpha-blocker RCT. For drugs with a narrow therapeutic index, clinical equivalence was noted in all five warfarin RCTs and a single Class 1 anti-arrhythmic-agent RCT.
The aggregate effect size was -0.03 (95% CI, -0.15 to 0.08), which indicates nearly complete overlap of the generic and brand-name distributions. The data show no evidence of superiority of brand-name to generic drugs in clinical outcomes measured in the various studies.
In a separate review of editorials addressing generic substitution for cardiovascular drugs, 53% expressed a negative view of generic-drug substitution.
Bottom line: There is clinical equivalency between generic and brand-name drugs used in the treatment of cardiovascular disease. Despite this conclusion, a substantial number of editorials advise against generic substitution, which affects both patient and physician drug preferences.
Citation: Kesselheim A, Misono A, Lee J, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008; 300(21):2514-2526.