Empagliflozin on the risk of retinopathy in patients with type 2 diabetes: Results from the EMPRISE study

EMPRISE aims to assess the effectiveness and safety of empagliflozin in patients with type 2 diabetes (T2D) in routine care. Within EMPRISE, we investigated two diabetic retinopathy (DR) outcomes among adults with T2D initiating empagliflozin or DPP4 inhibitors (DPP4i) in 2 separate cohorts. Using data from Medicare-fee-for-service and 2 U.S. commercial claims databases (2014-2019), we compared the risk of non-proliferative DR (NPDR) onset (cohort 1) and the risk of DR progression (cohort 2). To evaluate the onset of NPDR, we identified 34,262 1:1 propensity-score matched (PSM) patient pairs without history of any DR (Table). To evaluate DR progression (see Table for definition), we identified 7,839 1:1 PSM patient pairs with history of NPDR and without diagnosis or treatment for advanced DR prior to cohort entry. We estimated pooled HR and RD/1,000 PY with 95% CI adjusting for 143 baseline covariates. Compared to DPP4i, a similar risk of NPDR onset was observed with empagliflozin initiation [HR: 1.05 (0.95, 1.16); RD: 1.52 (-1.61, 4.65)] and a decreased risk of DR progression [HR: 0.77 (0.62, 0.95); RD: -9.49 (-16.90, -2.08)], over a mean follow-up of ~8 months on treatment. In routine care in a broad population of patients with T2D empagliflozin was associated with a lower risk of DR progression in line with direction and magnitude of a similarly defined DR outcome in the EMPA-REG OUTCOME trial. Disclosure H.Tesfaye: None. P.T.Htoo: Employee; Johnson & Johnson. J.M.Paik: None. H.Zakoul: None. N.Schmedt: Employee; Boehringer Ingelheim International GmbH. A.Deruaz-luyet: Employee; Boehringer Ingelheim International GmbH. L.Koeneman: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. D.J.Wexler: Other Relationship; Novo Nordisk A/S. E.Patorno: Research Support; Boehringer Ingelheim Inc., National Institutes of Health, Patient-Centered Outcomes Research Institute, US Food and Drug Administration.