title: Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).
abstract: OBJECTIVE
  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.
  
  
  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.affiliation: Division of Diabetes, Metabolism and Endocrinology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Utsunomiya
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Shimmoto
authors.affiliation: Medical Affairs, Sanofi K.K., Tokyo, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Senda
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Kurihara
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Ryoji
authors.initials: R
authors.lastname: Gunji
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Shoko
authors.initials: S
authors.lastname: Fujii
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Seigo
authors.initials: S
authors.lastname: Kakiuchi
authors.affiliation: Post Marketing Surveillance Department, Kowa Company, Ltd., Tokyo, Japan.
authors.forename: Hisataka
authors.initials: H
authors.lastname: Fujiwara
authors.affiliation: Medical Affairs, Sanofi K.K., Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kameda
authors.affiliation: Diabetes & Cardiovascular Medical Operations, Sanofi K.K., Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tamura
authors.affiliation: Department of General Internal Medicine 1, Kawasaki Medical School, Kurashiki, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Kaku
mesh_terms: D000368:Aged; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005960:Glucosides / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007564:Japan; D008297:Male; D011358:Product Surveillance, Postmarketing; D051247:Sodium-Glucose Transport Proteins / Q000037:antagonists & inhibitors
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; D051247:Sodium-Glucose Transport Proteins; C575086:6-((4-ethylphenyl)methyl)-3',4',5',6'-tetrahydro-6'-(hydroxymethyl)spiro(isobenzofuran-1(3H),2'-(2H)pyran)-3',4',5'-triol
keywords: Elderly; Sodium-glucose transporter 2; Type 2 diabetes mellitus