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Glucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System
  1. Gian Paolo Fadini1,
  2. Mayur Sarangdhar2,
  3. Angelo Avogaro3
  1. 1 Department of Medicine, University of Padua, Padova, Italy
  2. 2 Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio, USA
  3. 3 Department of Clinical and Experimental Medicine, University of Padua, Padova, Italy
  1. Correspondence to Professor Gian Paolo Fadini; gianpaolo.fadini{at}unipd.it

Abstract

Objectives Glucagon-like peptide-1 receptor agonists (GLP-1RA) are widely used for the treatment of type 2 diabetes. In large trials, the GLP-1RAs liraglutide and semaglutide improved cardiovascular outcomes, but semaglutide was associated with an increased risk of retinopathy progression. We herein evaluated the association between GLP-1RA and retinal adverse events (AE) in the Food and Drug Administration Adverse Event Reporting System (FAERS).

Research design and methods We mined the FAERS between 2004q1 and 2017q1 (for a total of 9 217 555 AE reports) to analyze disproportionality and evaluate the association between GLP-1RAs and AEs involving the retina. We compared the frequency of retinal AEs among reports including GLP-1RAs and in those including other glucose-lowering medications (GLMs) as suspect or concomitant drugs.

Results We retrieved 114 814 reports involving GLP-1RA and 694 725 reports involving other GLMs as suspect or concomitant drugs. The cumulative frequency of retinal AEs was 2.53/1000 for reports involving GLP-1RA vs 6.62/1000 for reports involving other GLMs, with a proportional reporting ratio of 0.38 (95% CI 0.34 to 0.43; P<0.0001). Reports involving GLP-1RAs listed significantly more comorbid conditions and concomitant medications. Findings were consistent after filtering the diabetes indication irrespective of concomitant GLM, in reports including and in those not including insulin, and for the various GLP-1RAs.

Conclusions In the FAERS there is no evidence that GLP-1RAs are associated with AEs suggestive of retinopathy progression. Despite more comorbid conditions and concomitant medications, in reports with GLP-1RA the frequency of retinal AEs was significantly lower than in reports with other GLMs.

  • retinopathy
  • glp-1
  • pharmacoepidemiology
  • adverse drug reactions

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors GPF designed the study, collected and analyzed the data, and wrote the manuscript. MS analyzed the data and revised the manuscript. AA designed the study and revised the manuscript.

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests GPF reports grants, personal fees and non-financial support from AstraZeneca, personal fees and non-financial support from Boehringer Ingelheim, grants, personal fees and non-financial support from Eli Lilly, personal fees and non-financial support from Novo Nordisk, personal fees and non-financial support from Sanofi, non-financial support from Genzyme, personal fees and non-financial support from Abbott, personal fees and non-financial support from Novartis, and personal fees from Merck Sharp & Dohme. MS reported no conflict of interest. AA reports grants, personal fees and non-financial support from AstraZeneca, personal fees from Boehringer Ingelheim, personal fees from Janssen, personal fees from Merck Sharp & Dohme, personal fees and non-financial support from Novartis, personal fees from Sanofi, grants and personal fees from Mediolanum, personal fees from Novo Nordisk, personal fees from Lilly, personal fees and non-financial support from Servier, and personal fees from Takeda.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data on which the research is based are already publicly available in the FAERS, as specified in the Methods section.

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