The DIVE/DPV registries: Evolution of empagliflozin use in clinical practice in Germany

Abstract

Introduction Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin. Research design and methods Data from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014-2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected. Results Over time, the proportion of recipients aged 65 years decreased (71.1 vs 54.4 among early and late adopters), male patients increased (from 50.9 to 66.5), body mass index (mean±SD) decreased (from 35.5±6.7 to 32.7±6.6 kg/m 2), proportion with cardiovascular morbidities increased (from 20.4 to 26.4), and mean estimated glomerular filtration rate decreased (from 83.2±19.5 to 78.5±21.1 mL/min/1.73 m 2) (all p 0.001). Patients increasingly received empagliflozin in combination with metformin (60.8 vs 68.6 of early and late adopters; p 0.001), glucagon-like peptide-1 (GLP-1) agonists (11.0 vs 14.1; p 0.001) or insulin (34.3 vs 49.9; p 0.001). Empagliflozin was generally added to existing antidiabetic regimens. Six months after empagliflozin initiation, the mean glycated hemoglobin (HbA1c) decreased by 0.4, the proportion of patients with HbA1c 6.5 increased (19.2 vs 12.8), and the mean fasting plasma glucose decreased (155.8±49.7 vs 168.0±55.1 mg/dL) (all p 0.001). No significant changes in rates of severe hypoglycemia and no cases of diabetic ketoacidosis were seen. Conclusions Over time, empagliflozin is being prescribed to a broader patient range in routine practice, is usually added to existing antidiabetic regimens, and is increasingly used in combination with metformin, GLP-1 agonists and/or insulin. Empagliflozin had a beneficial effect on glycemic control, with no increase in hypoglycemia.