Ichiro Nakamura1, Hiroshi Maegawa2, Kazuyuki Tobe3, Hiromi Tabuchi1, Satoshi Uno1. 1. a Astellas Pharma Inc ., Tokyo , Japan. 2. b Department of Medicine , Shiga University of Medical Science , Shiga , Japan. 3. c First Department of Internal Medicine , University of Toyama , Toyama , Japan.
Abstract
BACKGROUND: Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). RESEARCH DESIGN AND METHODS: All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. RESULTS: At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). CONCLUSIONS: Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.
BACKGROUND: Data regarding the efficacy and safety of sodium-glucose cotransporter 2 inhibitors in the real-world setting in Japan are limited. The STELLA-LONG TERM study is an ongoing 3-year post-marketing surveillance study of ipragliflozin in type 2 diabetes (T2D) patients. Here, we report the interim results (including 3-, 12-, and 24-month data). RESEARCH DESIGN AND METHODS: All Japanese patients with T2D who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan were registered in STELLA-LONG TERM. RESULTS: At 3, 12, and 24 months, the safety analysis set comprised 11,053, 5475, and 138 patients, respectively; the efficacy analysis set comprised 8757 patients. Ipragliflozin treatment resulted in statistically significant improvements versus baseline in hemoglobin A1c, fasting plasma glucose concentration, body weight, blood pressure, heart rate, and serum concentrations of low-density lipoprotein cholesterol and triglycerides. The adverse drug reaction incidence rate was 10.71%, the most common reactions being renal and urinary disorders (5.06%), infections and infestations (1.24%), and skin and subcutaneous tissue disorders (1.14%). CONCLUSIONS:Ipragliflozin was well tolerated and effective in Japanese patients with T2D; no new safety issues were identified.
Authors: Anastasios Tentolouris; Panayotis Vlachakis; Evangelia Tzeravini; Ioanna Eleftheriadou; Nikolaos Tentolouris Journal: Int J Environ Res Public Health Date: 2019-08-17 Impact factor: 3.390