Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real‐world clinical practice: Results of a 36‐month post‐marketing surveillance study (J‐STEP/LT). Issue 2 (25th August 2020)

• Record Type: Journal Article
• Authors: Utsunomiya, Kazunori; Koshida, Ryusuke; Kakiuchi, Seigo; Senda, Masayuki; Fujii, Shoko; Kurihara, Yuji; Gunji, Ryoji; Kaku, Kohei
• Is Part Of: Journal of diabetes investigation. Volume 12:Issue 2(2021)
• Page Start: 184
• Page End: 199
• Publication Date: 2020-08-25
• Subjects: Post‐marketing surveillance -- Tofogliflozin -- Type 2 diabetes mellitus; Diabetes -- Periodicals; Diabetes -- Research -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1111/jdi.13333
• Languages: English
• ISSNs: 2040-1116

Abstract

Abstract: Aims/Introduction: Tofogliflozin is a sodium–glucose cotransporter 2 (SGLT2) inhibitor that lowers plasma glucose levels by enhancing urinary glucose excretion. After its approval in Japan in 2014 for the treatment of type 2 diabetes mellitus, we carried out a 3‐year prospective observational post‐marketing surveillance study in Japanese patients (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term [J‐STEP/LT]). Materials and Methods: This surveillance was carried out between September 2014 and February 2019, and recorded safety in terms of adverse drug reactions (ADRs) and ADRs of special interest, and effectiveness in terms of changes in glycated hemoglobin and bodyweight from baseline to last observation carried forward. Results: Of 6, 897 patients with type 2 diabetes mellitus registered, 6, 711 and 6, 451 were analyzed for safety and effectiveness, respectively. ADRs were reported in 846 patients (12.61%), with serious ADRs in 101 patients (1.5%). ADRs of special interest included hypoglycemia (62 patients [0.9%]), polyuria/pollakiuria (90 [1.3%]), volume depletion‐related disorders (135 [2.0%]), urinary tract infections (91 [1.4%]), genital infections (117 [1.7%]) and skin diseases (53 [0.8%]). One case of diabetic ketoacidosis was reported. The mean ± standard deviation changes from baseline to last observation carried forward in glycated hemoglobin and bodyweight were −0.68 ± 1.34% ( n = 6, 158, P < 0.0001) and −3.13 ± 4.67 kg ( n = 5, 213, P < 0.0001), respectively. Conclusions: J‐STEP/LT, a 3‐year, prospective, observational, post‐marketing study in Japan, found no unprecedented ADRs, and consistent reductions from baseline in glycated hemoglobin and bodyweight over the observation period. The present results provide further evidence regarding the safety and tolerability of tofogliflozin in Japanese patients with type 2 diabetes mellitus. Abstract : Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term was a 3‐year, prospective, observational and post‐marketing study of patients who received tofogliflozin, a sodium–glucose cotransporter 2 inhibitor, in usual clinical practice in Japan. There were no unprecedented adverse drug reactions. Reductions from baseline in HbA1c and bodyweight were maintained over the observation period.