Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis

Aaron S. Kesselheim, Margaret R. Stedman, Ellen J. Bubrick, Joshua J. Gagne, Alexander S. Misono, Joy L. Lee, M. Alan Brookhart, Jerry Avorn, William H. Shrank

Research output: Contribution to journalArticle

142 Scopus citations

Abstract

Background: The automatic substitution of bioequivalent generics for brandname antiepileptic drugs (AEDs) has been linked by anecdotal reports to loss of seizure control. Objective: To evaluate studies comparing brand-name and generic AEDs, and determine whether evidence exists of superiority of the brand-name version in maintaining seizure control. Data Sources: English-language human studies identified in searches of MEDLINE, EMBASE and International Pharmaceutical Abstracts (1984 to 2009). Study Selection: Randomized controlled trials (RCTs) and observational studies comparing seizure events or seizure-related outcomes between one brand-name AED and at least one alternative version produced by a distinct manufacturer. Data Extraction: We identified 16 articles (9 RCTs, 1 prospective nonrandomized trial, 6 observational studies). We assessed characteristics of the studies and, for RCTs, extracted counts for patients whose seizures were characterized as 'controlled' and 'uncontrolled'. Data Synthesis: Seven RCTs were included in the meta-analysis. The aggregate odds ratio (n = 204) was 1.1 (95% CI 0.9, 1.2), indicating no difference in the odds of uncontrolled seizure for patients on generic medications compared with patients on brand-name medications. In contrast, the observational studies identified trends in drug or health services utilization that the authors attributed to changes in seizure control. ORIGINAL RESEARCH ARTICLE Drugs 2010; 70 (5): 605-621 0012-6667/10/0005-0605/$55. 55/0

Original languageEnglish (US)
Pages (from-to)605-621
Number of pages17
JournalDrugs
Volume70
Issue number5
DOIs
StatePublished - Mar 31 2010
Externally publishedYes

ASJC Scopus subject areas

  • Pharmacology (medical)

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    Kesselheim, A. S., Stedman, M. R., Bubrick, E. J., Gagne, J. J., Misono, A. S., Lee, J. L., Brookhart, M. A., Avorn, J., & Shrank, W. H. (2010). Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis. Drugs, 70(5), 605-621. https://doi.org/10.2165/10898530-000000000-00000