Comparing the use of individual and composite terms to evaluate adverse drug event disproportionality: a focus on glucagon-like peptide-1 receptor agonists and diabetic retinopathy

Daniel G. Dauner, Joel F. Farley

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The SUSTAIN-6 trial showed significantly higher rates of retinopathy complications in the semaglutide group compared to placebo. Observational studies have not consistently corroborated this finding, raising questions about the appropriateness of composite variables and whether the relationship exists across the entire drug class or is limited to individual glucagon-like peptide 1 agonists (GLP-1RAs). The study objective was to evaluate the difference between using individual and composite terms to assess associations between GLP-1RAs and diabetic retinopathy events. Research Design and Methods: Reports from the US Food and Drug Administration Adverse Event Reporting System were utilized to examine relationships between GLP-1RAs and diabetic retinopathy events. A disproportionality analysis was conducted using the proportional reporting ratio. Results: Four GLP-1RAs demonstrated signals for diabetic retinopathy events. The GLP-1RA drug class had four diabetic retinopathy signals. Only semaglutide had a signal for the composite diabetic retinopathy outcome. The GLP-1RA drug class and the composite diabetic retinopathy outcome did not meet the PRR signal thresholds. Conclusions: The use of drug class level and composite outcome variables may mask diabetic retinopathy signals in comparison to individual drug assessments. Our results support the SUSTAIN-6 trial findings and suggest an association between four GLP-1RAs and diabetic retinopathy events.

Original languageEnglish (US)
Pages (from-to)475-480
Number of pages6
JournalExpert Opinion on Drug Safety
Volume20
Issue number4
DOIs
StatePublished - Apr 2021

Bibliographical note

Funding Information:
JF Farley reports receiving personal fees from Takeda for expert witness testimony and grant support from Astra Zeneca to the University of Minnesota for an unrelated research project. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Publisher Copyright:
© 2021 Informa UK Limited, trading as Taylor & Francis Group.

Keywords

  • Pharmacovigilance
  • adverse drug events
  • glucagon-like peptide-1 receptor agonists
  • post-marketing surveillance
  • proportional reporting ratio

PubMed: MeSH publication types

  • Journal Article

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