Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus: Results of 24‐month interim analysis of a long‐term post‐marketing study (J‐STEP/LT)

Journal of Diabetes Investigation

Kazunori Utsunomiya¹  Kohei Kaku²  Ryusuke Koshida³  Masayuki Senda⁴  Masahiro Tamura⁴  Hiroyuki Kameda⁴  Yuji Kurihara⁵  Seigo Kakiuchi⁵  Ryoji Gunji⁵  Shoko Fujii⁵ 

[1] Center for Preventive Medicine The Jikei University School of Medicine Tokyo Japan;Kawasaki Medical School Kurashiki Japan;Medical Affairs Sanofi K.K. Tokyo Japan;Post Marketing Clinical Research Sanofi K.K. Tokyo Japan;Post Marketing Surveillance Department Kowa Company, Ltd. Tokyo Japan;

关键词: Post‐marketing study;    Sodium–glucose transporter 2;    Tofogliflozin;   

DOI  :  10.1111/jdi.13233

来源: DOAJ

【 摘 要 】

Abstract Aims/Introduction Tofogliflozin is a potent and highly selective sodium–glucose cotransporter 2 inhibitor, and is currently used to treat patients with type 2 diabetes mellitus. We designed a 3‐year study of tofogliflozin in patients with type 2 diabetes mellitus to evaluate the safety and effectiveness in routine clinical practice. The 3‐ and 12‐month interim analysis showed tofogliflozin was well‐tolerated, safe and clinically effective. Here, we report the results of the 24‐month interim analysis. Materials and Methods This is a 3‐year prospective, observational and multicenter post‐marketing study (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term). Results Of the 6,897 patients enrolled, 6,712 and 6,461 patients were analyzed for the safety and effectiveness of tofogliflozin, respectively. During the 24‐month observation period, the incidence rates of adverse drug reactions (ADRs) and serious adverse drug reactions were 11.25 and 1.21%, respectively. As to adverse drug reactions of special interest, the incidence rates of hypoglycemia, polyuria/pollakiuria, volume depletion‐related events, urinary tract infections and genital infection were 0.83, 1.28, 1.46, 1.18 and 1.62%, respectively. Renal disorders, and cardiovascular and cerebrovascular disorders occurred in 0.63 and 0.76% of the patients, respectively. Glycated hemoglobin A1c and bodyweight decreased significantly by −0.70% (P < 0.0001) and −2.95 kg (P < 0.0001), respectively, from baseline to week 104 (last observation carried forward). Conclusions Significant safety concerns have not been observed, and clinical benefit including a long‐term reduction in glycated hemoglobin A1c over a 104‐week (24 months) observation period with weight loss was suggested in this 24‐month interim analysis of the 3‐year Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term in routine clinical practice.

【 授权许可】

Unknown