title: Japanese study of tofogliflozin with type 2 diabetes mellitus patients in an observational study of the elderly (J-STEP/EL): A 12-week interim analysis.
abstract: OBJECTIVE
  Sodium-glucose co-transporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, but are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing surveillance of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus and here report the results of a 12-week interim analysis, focusing on adverse drug reactions of special interest.
  
  
  METHODS
  The present prospective observational study included all type 2 diabetes mellitus patients aged ≥65 years who started tofogliflozin during the first 3 months after its launch. Data on demographic and baseline characteristics, clinical course and adverse events were collected.
  
  
  RESULTS
  Of 1,535 patients registered, 1,506 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis at 12 weeks. A total of 178 of 1,506 patients (11.82%) had at least one adverse drug reaction to tofogliflozin. The incidence of adverse drug reactions of special interest (polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, skin disorders and hypoglycemia) was 2.19, 2.32, 1.33, 1.13, 1.46 and 0.73%, respectively. No new safety concerns were identified. Among those evaluable for clinical effectiveness, the mean (standard deviation) glycated hemoglobin decreased from 7.65% (1.35%) at baseline to 7.25% (1.16%) at 12 weeks by 0.39% (0.94%; P < 0.0001).
  
  
  CONCLUSIONS
  This interim analysis characterized the safety profile of tofogliflozin in Japanese elderly patients with type 2 diabetes mellitus during the early post-marketing period.
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: Post Marketing Clinical Research, 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 Clinical Research, Sanofi K.K., Tokyo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Kameda
authors.affiliation: Post Marketing Clinical Research, Sanofi K.K., Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tamura
authors.affiliation: Medical Affairs, Sanofi K.K., Tokyo, Japan.
authors.forename: Hanako
authors.initials: H
authors.lastname: Mihara
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; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D005960:Glucosides / Q000009:adverse effects*; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D007564:Japan; D008297:Male; D011358:Product Surveillance, Postmarketing; D000077203:Sodium-Glucose Transporter 2 Inhibitors; D016896:Treatment Outcome
chemical_list: D001559:Benzhydryl Compounds; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000077203:Sodium-Glucose Transporter 2 Inhibitors; C517652:hemoglobin A1c protein, human; 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