Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: final results of a 3-year post-marketing surveillance study

Background: Empagliflozin, a sodium-glucose co-transporter-2 inhibitor, was licensed for treating type 2 diabetes (T2D) in Japan and elsewhere in recent years. We conducted a post-marketing surveillance study of empagliflozin in Japan. Research design and methods: This was a 3-year, prospective, multicenter, observational study of the safety and effectiveness of empagliflozin in T2D patients in Japanese clinical practice who had not previously received this medication. The primary endpoint was the incidence of adverse drug reactions (ADRs). Results: Of 8145 patients enrolled from 1103 sites, 7931 received >= 1 dose of empagliflozin. Mean age was 58.7 years (10.5% aged >= 75), glycated hemoglobin (HbA1c) 8.0%, body mass index 28.1 kg/m(2) (<20 kg/m(2) in 2.1%); 63.0% were male and most had comorbidities (renal impairment in similar to 62%). Median treatment duration was 36.5 months. ADRs occurred in 1024 (12.91%) patients overall (serious ADRs in 2.09%) and 120 patients aged >= 75 years (14.46%). ADRs of special interest included hypoglycemia (0.44% of patients), urinary tract infections (1.07%), genital infections (0.66%), volume depletion (0.50%), diabetic ketoacidosis (0%), and lower limb amputation (0.04%). Overall mean change in HbA1c from baseline was -0.75%. Conclusions: Empagliflozin is effective and generally well tolerated in Japanese patients, and ADRs are consistent with its known safety profile.