Efficacy of Dapagliflozin in Southern Europe Across the Spectrum of Characteristics of Type 2 Diabetes: An International Real-World Analysis

PURPOSE: To extend a prior real-world analysis (DARWIN-T2D) of patients with type 2 diabetes initiating dapagliflozin in Italy, Greece, and Spain by evaluating changes in glycemic and extra-glycemic endpoints after initiation of dapagliflozin. PATIENTS AND METHODS: The association among demographic/clinical characteristics and the change in glycemic and extraglycemic effectiveness endpoints during the observation period was assayed using a mixed effects model. RESULTS: A total of 1438 (860 males; 59.8%) patients were evaluated; patients were followed for a mean of 5.6 months. At baseline, 93.4% and 61.9% of patients were on concomitant metformin and insulin, respectively. A significant mean decrease in HbA1c from 8.7% to 7.5% was observed. The mixed model used also revealed several associations between different glycemic and laboratory parameters and patient characteristics at baseline; insulin use was significantly associated with lower HbA1c. Patients with BMI ≥30 kg/m(2) experienced greater weight loss than those with BMI <30 kg/m(2). A consistent glucose-lowering effect of dapagliflozin was seen in all subgroups of patients, including those with stage 2 renal impairment and cardiovascular disease. CONCLUSION: The present analysis confirms the efficacy of dapagliflozin in diversified real-world settings with broadly similar effects on HbA1c across countries and baseline characteristics.