Background: Dapagliflozin significantly improves glycemic control, body weight and blood pressure in Asian patients with type 2 diabetes mellitus (T2DM) , but safety data from studies with a large population are lacking. The DONATE study investigated the real-world safety of dapagliflozin in Chinese patients with T2DM.

Methods: This observational study enrolled patients with T2DM from 88 hospitals in China, who had received ≥1 dose of dapagliflozin between August 2017 and July 2020. Patients were followed for 6 months, or 7 days after discontinuing study drug. Primary outcome was the incidence of adverse events (AEs) and serious adverse events (SAEs) , particularly urinary tract infections (UTIs) , genital tract infections (GTIs) and hypoglycemia. Exploratory outcomes included the incidence of AEs of specific interest (AESI) and absolute changes in metabolic factors. Results: Of 3000 patients enrolled, 2990 patients were included in the safety analysis set; 1059 (35.4%) reported ≥1 AE, including 186 (6.2%) with ≥1 SAE. Adverse drug reaction was reported in 268 (9.0%) patients. In total, there were 70 (2.3%) , 39 (1.3%) and 32 (1.1%) patients with UTI, GTI and hypoglycemia, respectively. The occurrence of other AESIs was also low: polyuria (0.7%) , volume depletion (0.3%) , renal impairment (0.3%) , hepatic impairment (0.2%) , haematuria (0.2%) and diabetic ketoacidosis (0.1%) . There were no abnormal electrolytes events reported. At Week 24 (metabolic analysis set) , mean change from baseline in HbA1c was −1.318%; 161/417 (38.6%) achieved HbA1c <7.0%; Mean change from baseline in FPG, 2h-PPG, weight and waist circumference was −1.826 mmol/L, −5.466 mmol/L, −1.89 kg and -2cm, respectively.

Conclusion: Dapagliflozin showed a good safety profile in real-world clinical practice in China, with a low incidence of AEs, especially AESI. Meanwhile, a trend of improvement was found in blood glucose control as well as other metabolic factors.

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