RESUMEN
BACKGROUND: Sodium-glucose co-transporter-2 (SGLT2) inhibitors such as empagliflozin are increasingly prescribed as initial glucose-lowering drugs for type 2 diabetes (T2D), based on their cardiorenal benefits. However, information regarding the safety and the effectiveness of monotherapy with SGLT2 inhibitors in routine clinical practice is limited. RESEARCH DESIGN AND METHODS: We analyzed data from a prospective, 3-year, post-marketing surveillance study of empagliflozin in Japan. We evaluated adverse drug reactions (ADRs) (the primary endpoint) and glycemic effectiveness with or without other glucose-lowering drugs. RESULTS: 7931 T2D patients were treated with empagliflozin. At baseline, mean age was 58.7 years, 63.0% were male, and 1835 (23.14%) were not receiving other glucose-lowering drugs. ADRs occurred in 141 (7.68%) and 875 (14.62%) patients initiating empagliflozin as monotherapy or combination therapy, respectively. The most frequent ADRs of special interest with empagliflozin as monotherapy or combination therapy were urinary tract infections (0.82% and 1.14% of patients, respectively) and excessive/frequent urination (0.65%, 1.50%). At last observation, glycated hemoglobin level was reduced by a mean of 0.78% with empagliflozin monotherapy (from baseline mean of 7.55%) and 0.74% with combination therapy (baseline 8.16%). CONCLUSIONS: Empagliflozin is well tolerated and effective in clinical practice in Japan when initiated as monotherapy or combination therapy.
