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

Feb 8, 2021Expert opinion on drug safety

Comparing single and combined measures to detect drug-related eye problems with diabetes medications called GLP-1 receptor agonists

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Abstract

The SUSTAIN-6 trial found significantly higher rates of retinopathy complications in the semaglutide group compared to placebo.

Four GLP-1 receptor agonists (GLP-1RAs) showed signals for diabetic retinopathy events.
Only semaglutide indicated a signal for the composite diabetic retinopathy outcome.
The GLP-1RA drug class did not meet the thresholds for the proportional reporting ratio (PRR).
Using composite outcome variables may obscure the detection of diabetic retinopathy signals compared to individual drug evaluations.
The findings align with the SUSTAIN-6 trial and suggest a potential association between GLP-1RAs and diabetic retinopathy events.

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: 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.: 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.: 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.: 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. Background Research Design and Methods Results Conclusions

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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

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