Glucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System

Feb 17, 2018BMJ open diabetes research & care

Glucagon-like peptide-1 receptor drugs are not linked to eye problems in FDA safety reports

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Abstract

The cumulative frequency of retinal adverse events was 2.53/1000 for glucagon-like peptide-1 receptor agonists (GLP-1RAs) compared to 6.62/1000 for other glucose-lowering medications.

GLP-1RAs were reported in 114,814 cases, while other glucose-lowering medications appeared in 694,725 reports.
The proportional reporting ratio for retinal adverse events with GLP-1RAs was 0.38, indicating a significantly lower occurrence compared to other glucose-lowering medications.
Reports involving GLP-1RAs included a higher number of comorbid conditions and concomitant medications.
Findings remained consistent when filtering for diabetes indication and across different GLP-1RAs, regardless of insulin use.

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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.

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Glucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System

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