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To the Editor: Hathaway et al 1 reported on a relatively high 36-month cumulative incidence of nonarteritic anterior ischemic optic neuropathy (NAION), 8.9% (95% CI, 4.5%-13.1%), among a cohort of semaglutide users (n = 169) with evidence of type 2 diabetes who received care in a neuro-ophthalmology clinic at an academic medical center. Most NAION cases were observed in the first year. In August 2022, the US Food and Drug Administration used its Sentinel System 2 —a multisite, national electronic health care data network that then contained more than 65 million unique patients with commercial or Medicare insurance—to monitor potential adverse effects among semaglutide users with evidence of diabetes.3 New users of semaglutide were matched 1:1 to new users of sitagliptin (a dipeptidyl peptidase 4 inhibitor, another class of antidiabetes drugs that were also included in the comparison group in the study by Hathaway et al1 ) using propensity scores, including a high-dimensional propensity score (hdPS) sensitivity analysis to account for underlying disease severity. With more than 134 000 matched pairs identified, data were collected on event frequency in the first 6 months after treatment initiation for up to 83 000 International Statistical Classification of Diseases, Tenth Revision, Clinical Modification nonpregnancy and noncancer diagnosis codes and analyzed for imbalances in outcome occurrence using tree-based scan statistics.
- 1 a b Hathaway JT, Shah MP, Hathaway DB, Zekavat SM, Krasniqi D, Gittinger JW Jr, Cestari D, Mallery R, Abbasi B, Bouffard M, Chwalisz BK, Estrela T, Rizzo JF III. Risk of Nonarteritic Anterior Ischemic Optic Neuropathy in Patients Prescribed Semaglutide. JAMA Ophthalmology [Internet]. 2024 Jul 3 [cited 2024 Jul 11]; Available from: https://doi.org/10.1001/jamaophthalmol.2024.2296
- 2Ball R, Robb M, Anderson SA, Dal Pan G. The FDA’s sentinel initiative--A comprehensive approach to medical product surveillance. Clin Pharmacol Ther. 2016 Mar;99(3):265–8.
- 3Ozempic (semaglutide) | Sentinel Initiative [Internet]. [cited 2024 Jul 11]. Available from: https://sentinelinitiative.org/studies/drugs/ozempic-semaglutide