Safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes mellitus in real‐world clinical practice: Results of 3‐month interim analysis of a long‐term post‐marketing surveillance study (J‐STEP/LT)

Journal of Diabetes Investigation

Kohei Kaku¹  Kazunori Utsunomiya²  Masayuki Senda³  Masahiro Tamura³  Hiroyuki Kameda³  Yuji Kurihara⁴  Hisataka Fujiwara⁴  Seigo Kakiuchi⁴  Ryoji Gunji⁴  Shoko Fujii⁴ 

[1] Department of Medicine Kawasaki Medical School Kurashiki Japan;Division of Diabetes, Metabolism and Endocrinology Department of Internal Medicine The Jikei University School of Medicine Tokyo Japan;Medical Affairs Sanofi K.K. Tokyo Japan;Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan;

关键词: Post‐marketing study;    Tofogliflozin;    Type 2 diabetes mellitus;   

DOI  :  10.1111/jdi.13017

来源: DOAJ

【 摘 要 】

Abstract Aims/Introduction The present study analysis was carried out to evaluate the safety and efficacy of tofogliflozin, a sodium–glucose cotransporter 2 inhibitor, in Japanese patients with type 2 diabetes mellitus in real‐world clinical practice. Materials and Methods This was a 3‐year non‐interventional observational study of patients with type 2 diabetes mellitus newly administered tofogliflozin who were uncontrolled on current therapy. We carried out a 12‐week interim analysis of tofogliflozin as part of 3‐year post‐marketing surveillance study. The incidence of adverse drug reactions was evaluated as a safety end‐point. As efficacy end‐points, glycated hemoglobin and bodyweight were evaluated. Results A total of 6,897 patients were enrolled. Tofogliflozin significantly reduced mean changes from baseline glycated hemoglobin (−0.63%, P < 0.0001) and bodyweight (−2.02 kg, P < 0.0001). The change in glycated hemoglobin and bodyweight reductions in response to tofogliflozin was consistently observed in all body mass index subgroups. Adverse drug reactions occurred in 345 of 6,712 patients (5.14%). There was a low incidence of adverse drug reactions known to be associated with sodium–glucose cotransporter 2 inhibitors, and they were reported as non‐serious. The incidences of polyuria/pollakiuria were higher in patients aged ≥65 years than <65 years, and were significantly different among estimated glomerular filtration rate subgroups. Urinary tract and genital infections occurred more frequently in women than in men. Conclusions Tofogliflozin was well tolerated, and no emerging new safety concerns were observed. Tofogliflozin significantly improved glycemic control with no impact on bodyweight gain. The short‐term administration of tofogliflozin is considered to have a favorable benefit–risk profile in Japanese patients with type 2 diabetes mellitus.

【 授权许可】

Unknown