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 Lee, M. Alan Brookhart, Jerry Avorn, William H. Shrank

Research output: Contribution to journalArticle

136 Citations (Scopus)

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

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Anticonvulsants
Names
Meta-Analysis
Seizures
Randomized Controlled Trials
Observational Studies
Pharmaceutical Preparations
Drug Substitution
Generic Drugs
Information Storage and Retrieval
MEDLINE
Health Services
Language
Odds Ratio

ASJC Scopus subject areas

  • Pharmacology (medical)

Cite this

Kesselheim, A. S., Stedman, M. R., Bubrick, E. J., Gagne, J. J., Misono, A. S., Lee, 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

Seizure outcomes following the use of generic versus brand-name antiepileptic drugs : A systematic review and meta-analysis. / Kesselheim, Aaron S.; Stedman, Margaret R.; Bubrick, Ellen J.; Gagne, Joshua J.; Misono, Alexander S.; Lee, Joy; Brookhart, M. Alan; Avorn, Jerry; Shrank, William H.

In: Drugs, Vol. 70, No. 5, 31.03.2010, p. 605-621.

Research output: Contribution to journalArticle

Kesselheim, AS, Stedman, MR, Bubrick, EJ, Gagne, JJ, Misono, AS, Lee, J, Brookhart, MA, Avorn, J & Shrank, WH 2010, 'Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: A systematic review and meta-analysis', Drugs, vol. 70, no. 5, pp. 605-621. https://doi.org/10.2165/10898530-000000000-00000
Kesselheim, Aaron S. ; Stedman, Margaret R. ; Bubrick, Ellen J. ; Gagne, Joshua J. ; Misono, Alexander S. ; Lee, Joy ; Brookhart, M. Alan ; Avorn, Jerry ; Shrank, William H. / Seizure outcomes following the use of generic versus brand-name antiepileptic drugs : A systematic review and meta-analysis. In: Drugs. 2010 ; Vol. 70, No. 5. pp. 605-621.
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