Dataset Information

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

ABSTRACT: Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus.This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ?65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014.Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively.The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ?65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels.

SUBMITTER: Utsunomiya K

PROVIDER: S-EPMC5668483 | biostudies-other | 2017 Nov

REPOSITORIES: biostudies-other

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Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

Utsunomiya Kazunori K Shimmoto Naoki N Senda Masayuki M Kurihara Yuji Y Gunji Ryoji R Fujii Shoko S Kakiuchi Seigo S Fujiwara Hisataka H Kameda Hiroyuki H Tamura Masahiro M Kaku Kohei K

Journal of diabetes investigation 20170306 6

<h4>Aims/introduction</h4>Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus.<h4>Materials and methods</h4>This was a prospective, observational and multicenter post-marketing study carried out in the context of routine ...[more]

PMID: 28107773

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Dataset Information

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

Publications

Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

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