title: Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study.
abstract: OBJECTIVE
  To investigate the real-world safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  Japanese patients (≥65 years old) who were first prescribed ipragliflozin within 3 months after its launch in April 2014 were registered in this post-marketing surveillance (PMS). Final data collection was in July 2015. Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables.
  
  
  RESULTS
  The PMS included 8505 patients (4181 males/4324 females). The mean age and diabetes duration were 72.3 years and 10.6 years, respectively. In 84.3% of patients, ipragliflozin was prescribed at 50 mg/day, which was continued unchanged. Overall, 16.91% of patients experienced 1880 ADRs, and 165 ADRs were classified as serious in 127 patients (1.49%). ADRs of special interest included skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, renal disorders, hypoglycemia, cerebrovascular disease, cardiovascular disease, malignant tumor, fracture, and ketone body-related events.
  
  
  CONCLUSIONS
  This 1-year PMS revealed probable ADRs in elderly Japanese patients with T2DM prescribed ipragliflozin in real-world settings, with no new safety concerns. The risk factors for ADRs varied but could be rationalized. The results should help physicians to identify possible treatment-emergent ADRs in ipragliflozin-treated patients.
authors.affiliation: a Department of Medicine , Chiba University Graduate School of Medicine , Chiba , Japan.
authors.forename: Koutaro
authors.initials: K
authors.lastname: Yokote
authors.affiliation: b Yokohama City University Graduate School of Medicine , Yokohama , Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: c Astellas Pharma Inc ., Tokyo , Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Nakamura
authors.affiliation: c Astellas Pharma Inc ., Tokyo , Japan.
authors.forename: Haruko
authors.initials: H
authors.lastname: Sugamori
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D005960:Glucosides / Q000627:therapeutic use*; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013876:Thiophenes / Q000627:therapeutic use*
chemical_list: D001786:Blood Glucose; D005960:Glucosides; D007004:Hypoglycemic Agents; D013876:Thiophenes; C572941:ipragliflozin
keywords: Elderly; SGLT2 inhibitors; ipragliflozin; post-marketing surveillance; type 2 diabetes mellitus