Evidence map›Paper›PMID 20329806›Full record

SynthesisDrugs2010

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

Registry-linked trialOpen access · greenAbstract readMeta-AnalysisSystematic Review
In one paragraph

Synthesis in Drugs, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02429596 (A Randomized Controlled Trial of Generic Substitution of Antiepileptic Drugs), which is not on this map. Cited by 63 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 5 pooled it
62.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02429596 phase4unknown statusnot on this mapstarted 2012, after this paper: background citation

A Randomized Controlled Trial of Generic Substitution of Antiepileptic Drugs

TypeinterventionalSponsorIRCCS National Neurological Institute "C. Mondino" FoundationRan2012 to 2015Enrolled200ConditionsEpilepsyArmsExperimental
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 5 syntheses or guidelines pooled it, 189 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Review
  11. Therapeutic Basis of Generic Substitution of Antiseizure Medications.The Journal of pharmacology and experimental therapeutics · 2022
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. The Use of Generic Medications for Glaucoma.Journal of ophthalmology · 2020
    Review
  17. Article
  18. Article
  19. Article
  20. Article

3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Aaron S KesselheimDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts 02120, USA. akesselheim@partners.org
Margaret R Stedman
Ellen J Bubrick
Joshua J Gagne
Alexander S Misono
Joy L Lee
M Alan Brookhart
Jerry Avorn
William H Shrank
Brigham and Women's Hospital · USHarvard University · US

Funding

TRAINING PROGRAM IN EPIDEMIOLOGIC RESEARCH ON AGINGT32AG000158 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI GAZIANO, J. MICHAEL · 1988 to 2015
$2.1M
Off-label prescribing: Comparative evidence, regulation, and utilizationK08HS018465 · AHRQ · BRIGHAM AND WOMEN'S HOSPITAL · PI KESSELHEIM, AARON SETH · 2009 to 2013
$797k
An intervention to improve rational prescribing in cardiovascular diseaseK23HL090505 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SHRANK, WILLIAM · 2007 to 2010
$650k
AHRQ HHS K08HS18465-01NHLBI NIH HHS K23 HL090505NIA NIH HHS T32 AG000158
6 · The paper itself

Abstract

The automatic substitution of bioequivalent generics for brand-name antiepileptic drugs (AEDs) has been linked by anecdotal reports to loss of seizure control. 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. English-language human studies identified in searches of MEDLINE, EMBASE and International Pharmaceutical Abstracts (1984 to 2009). 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. 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'. 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. Although most RCTs were short-term evaluations, the available evidence does not suggest an association between loss of seizure control and generic substitution of at least three types of AEDs. The observational study data may be explained by factors such as undue concern from patients or physicians about the effectiveness of generic AEDs after a recent switch. In the absence of better data, physicians may want to consider more intensive monitoring of high-risk patients taking AEDs when any switch occurs.

Indexed as

AnticonvulsantsDrugs, GenericEvidence-Based MedicineHumansOdds RatioRandomized Controlled Trials as TopicRisk AssessmentSeizuresTherapeutic EquivalencyTreatment OutcomeAnticonvulsantsDrugs, Generic

Identifiers

PMID20329806
PMCPMC3056509
OpenAlexW2082929679

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.