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

Abstract

AIMS/INTRODUCTION:

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.

MATERIALS AND METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Kazunori Utsunomiya, Naoki Shimmoto, Masayuki Senda, Yuji Kurihara, Ryoji Gunji, Shoko Fujii, Seigo Kakiuchi, Hisataka Fujiwara, Hiroyuki Kameda, Masahiro Tamura, Kohei Kaku
• Journal: Journal of diabetes investigation (J Diabetes Investig) Vol. 8 Issue 6 Pg. 766-775 (Nov 2017) ISSN: 2040-1124 [Electronic] Japan
• PMID: 28107773 (Publication Type: Journal Article, Multicenter Study, Observational Study)
• Copyright: © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

Chemical References

• Benzhydryl Compounds
• Glucosides
• Hypoglycemic Agents
• Sodium-Glucose Transport Proteins
• 6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol

Topics

• Aged
• Benzhydryl Compounds (adverse effects, therapeutic use)
• Diabetes Mellitus, Type 2 (drug therapy)
• Female
• Glucosides (adverse effects, therapeutic use)
• Humans
• Hypoglycemic Agents (adverse effects, therapeutic use)
• Japan
• Male
• Product Surveillance, Postmarketing
• Sodium-Glucose Transport Proteins (antagonists & inhibitors)