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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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Glucagon-Like Peptide-1 Receptor Agonists Are Not Associated with Retinal Adverse Events in the FDA Adverse Event Reporting System Pathophysiology/Complications Open Access Original research BMJ Open Diab Res Care: first published as 10.1136/bmjdrc-2017-000475 on 30 January 2018. Downloaded from Glucagon-like peptide-1 receptor agonists are not associated with retinal adverse events in the FDA Adverse Event Reporting System Gian Paolo Fadini,1 Mayur Sarangdhar,2 Angelo Avogaro3 To cite: Fadini GP, ABSTRACT Sarangdhar M, Avogaro A. Objectives Glucagon-like peptide-1 receptor agonists Significance of this study Glucagon-like peptide-1 (GLP-1RA) are widely used for the treatment of type 2 receptor agonists are not diabetes. In large trials, the GLP-1RAs liraglutide and What is already known about this subject? associated with retinal adverse semaglutide improved cardiovascular outcomes, but ► The glucagon-like peptide-1 receptor agonists events in the FDA Adverse semaglutide was associated with an increased risk (GLP-1RA) liraglutide and semaglutide improved Event Reporting System. cardiovascular outcomes in people with type 2 of retinopathy progression. We herein evaluated the BMJ Open Diab Res Care diabetes. 2018;6:e000475. doi:10.1136/ association between GLP-1RA and retinal adverse events bmjdrc-2017-000475 (AE) in the Food and Drug Administration Adverse Event ► In the SUSTAIN-6 trial, the GLP-1RA semaglutide Reporting System (FAERS). was associated with an increased risk of Received 11 September 2017 Research design and methods We mined the FAERS retinopathy progression, but a meta-analysis rules Revised 13 December 2017 between 2004q1 and 2017q1 (for a total of 9 217 555 out that GLP-1RA as a class increases the risk of Accepted 8 January 2018 AE reports) to analyze disproportionality and evaluate the retinopathy. association between GLP-1RAs and AEs involving the What are the new findings? copyright. retina. We compared the frequency of retinal AEs among reports including GLP-1RAs and in those including other ► We analyzed a pharmacovigilance database glucose-lowering medications (GLMs) as suspect or containing almost 10 million adverse event (AE) concomitant drugs. reports to evaluate the association between Results We retrieved 114 814 reports involving GLP-1RA GLP-1RAs and retinal AEs and found no evidence and 694 725 reports involving other GLMs as suspect or that GLP-1RAs are associated with AEs suggestive concomitant drugs. The cumulative frequency of retinal of retinopathy progression. AEs was 2.53/1000 for reports involving GLP-1RA vs ► Despite more comorbid conditions and concomitant 6.62/1000 for reports involving other GLMs, with a medications, the frequency of retinal AEs for proportional reporting ratio of 0.38 (95% CI 0.34 to 0.43; GLP-1RAs was significantly lower than for other P<0.0001). Reports involving GLP-1RAs listed significantly glucose-lowering medications. http://drc.bmj.com/ more comorbid conditions and concomitant medications. How might these results change the focus of Findings were consistent after filtering the diabetes indication irrespective of concomitant GLM, in reports research or clinical practice? including and in those not including insulin, and for the ► Our findings reassure the risk of retinopathy various GLP-1RAs. progression raised by the SUSTAIN-6 trial. Conclusions In the FAERS there is no evidence that GLP- ► Other explanations for the increased retinopathy 1RAs are associated with AEs suggestive of retinopathy progression observed with semaglutide therapy progression. Despite more comorbid conditions and need to be considered. on September 23, 2021 by guest. Protected concomitant medications, in reports with GLP-1RA the frequency of retinal AEs was significantly lower than in 1Department of Medicine, reports with other GLMs. liraglutide significantly reduced cardiovas- 2 University of Padua, Padova, cular events and mortality. In the premar- Italy keting SUSTAIN-6 trial, the once-weekly 2 Cincinnati Children’s Hospital GLP-1RA semaglutide, which is structur- Medical Center, Cincinnati, INTRODUCTION ally related to liraglutide, also significantly Ohio, USA 3 3Department of Clinical and Glucagon-like peptide-1 receptor agonists reduced cardiovascular events. Differently, Experimental Medicine, (GLP-1RAs) are widely used for the treatment the short-acting GLP-1RA lixisenatide and University of Padua, Padova, of type 2 diabetes. Thanks to their glycemic the once-weekly exenatide had a neutral Italy and extraglycemic effects, GLP-1RAs are effect on cardiovascular outcomes.4 5 expected to exert protective effects on Interestingly, both liraglutide and sema- Correspondence to 1 Professor Gian Paolo Fadini; chronic diabetic complications. In a post- glutide showed evidence of renal protec- 3 6 gianpaolo. fadini@ unipd. it marketing trial, the once-daily GLP-1RA tion, but semaglutide was associated with BMJ Open Diab Res Care 2018;6:e000475. doi:10.1136/bmjdrc-2017-000475 1 Pathophysiology/Complications BMJ Open Diab Res Care: first published as 10.1136/bmjdrc-2017-000475 on 30 January 2018. Downloaded from a significant 76% increased risk of retinopathy compli- Queries cations (vitreous hemorrhage, blindness, or conditions To perform an unbiased analysis of disproportionality requiring treatment with an intravitreal agent or photo- within the FAERS, we used AERSMine,16 a web-based coagulation).3 A similar phenomenon was reported previ- software, to mine the FAERS, which accesses files from ously with other GLP-1RAs.7 The possible reasons for such 2004q1 to 2017q1, for a total of 9 217 555 reports. Queries unexpected findings in SUSTAIN-6 include issues related were run on AERSMine to analyze disproportionality to trial design, the rapid improvement in glucose control, and evaluate the association between GLP-1RA and AEs 8 and a direct angiogenic or toxic effect of semaglutide. involving the retina. In the first search strategy (model Of note, preclinical studies have shown that topical treat- 1), we compared the frequencies of retinal AEs among ment with a GLP-1RA or a dipeptidyl peptidase-4 inhib- reports listing GLP-1RA versus reports listing any other itor protects from neurodegeneration in experimental glucose-lowering medication (GLM) except GLP-1RA. 9 10 diabetic retinopathy. These data argue against a direct To be more specific, in the second search strategy (model adverse effect of GLP-1RA on retinopathy progression, 2), we filtered only reports with an expanded diabetes but an eventual proangiogenic effect of semaglutide still indication. We retrieved the number and frequencies needs to be ruled out. of each specific retinal AE, as well as the total number Importantly, a recent meta-analysis of randomized of unique reports of at least one retinal AE. We also controlled trials (RCTs) found that treatment with recorded concomitant medications grouped by thera- GLP1-RAs, as a class, was not associated with a signifi- 11 peutic category and concomitant indications grouped cant increase in the incidence of retinopathy. Studies by system organ class. Figure 1 illustrates the study query using routinely accumulated clinical data are useful 12 flow chart. to complement or challenge RCT findings. Since The following search strings were used for AERSMine adverse event (AE) reporting is a routine duty of clini- queries: cians, pharmacovigilance studies belong to such cate- GLP-1RA group: ‘insulin degludec and liraglutide’ or gory of ‘real world studies’. We argue that, if GLP-1RA ‘liraglutide’ OR ‘exenatide’ OR ‘lixisenatide’ OR ‘albi- were truly associated with retinopathy progression, this glutide’ OR ‘dulaglutide’ OR ‘teduglutide’. should emerge as a safety signal from pharmacovigilance Control group: ‘insulins and analogues’ OR ‘insulins assessment, as it recently occurred for the association and analogues for injection, long-acting’ OR ‘insulins between canagliflozin and amputations.13 14 Thus, to eval- copyright. and analogues for injection, fast-acting’ OR ‘insulins uate the association between GLP-1RAs and retinopathy, and analogues for injection, intermediate- or long-acting we herein analyzed the Food and Drug Administration combined with fast-acting’ OR ‘insulins and analogues for (FDA) Adverse Event Reporting System (FAERS), which injection, intermediate-acting’ OR ‘insulin glargine’ OR is a global pharmacovigilance database used to monitor ‘insulin (human)’ OR ‘insulins and analogues for inhala- drugs’ safety signals. tion’ OR ‘insulin lispro’ OR ‘insulin aspart’ OR ‘insulin detemir’ OR ‘insulin glulisine’ OR ‘insulin degludec’ OR RESEARCH DESIGN AND METHODS ‘insulin (pork)’ OR ‘insulin (beef)’ OR ‘insulin degludec Data source and insulin aspart’ OR ‘canagliflozin’ OR ‘dapagliflozin’ Pharmacovigilance databases can be used to assess a OR ‘empagliflozin’ OR ‘sitagliptin’ OR ‘saxagliptin’ http://drc.bmj.com/ drug’s safety by evaluating disproportional associations OR ‘linagliptin’ OR ‘vildagliptin’ OR ‘alogliptin’ OR between the drug and one or more AEs. If there is no ‘metformin’ OR ‘glibenclamide’ OR ‘glimepiride’ OR link between a drug and an AEs, the frequency of such ‘gliclazide’ OR ‘tolbutamide’ OR ‘chlorpropamide’ OR AEs will be uniformly distributed in reports listing and ‘glipizide’ OR ‘gliquidone’ OR ‘rosiglitazone’ OR ‘piogl- in those not listing that drug as suspect or concomitant, itazone’ OR ‘troglitazone’ OR ‘acarbose’ OR ‘voglibose’ without disproportionality. On the contrary, AEs that are OR ‘repaglinide’ OR ‘nateglinide’ OR ‘mitiglinide’. on September 23, 2021 by guest. Protected caused by a drug will occur more frequently in reports Excluded: ‘insulin degludec and liraglutide’
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