title: Safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): Interim results of a post-marketing surveillance study.
abstract: OBJECTIVE
  To determine the incidence of adverse drug reactions (ADRs) associated with ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus.
  
  
  METHODS
  We report interim results of a postmarketing surveillance survey. Japanese physicians recorded ADRs in elderly patients (≥ 65 years old) who were first prescribed with ipragliflozin within 3 months of its launch (April 2014).
  
  
  METHODS
  Incidence of ADRs within 1 year of starting treatment with ipragliflozin.
  
  
  RESULTS
  898 ADRs occurred in 721/7,170 patients (10.06%). Skin complication-, volume depletion-, genital infection-, polyuria/pollakiuria-, urinary tract infection-, and hypoglycemia-related ADRs occurred in 2.23%, 1.90%, 1.45%, 1.32%, 0.77%, and 0.32%, respectively. ADRs were classified as serious in 44 (0.61%) patients. Half of the ADRs occurred within 30 days of starting treatment. There were no cases of Stevens-Johnson syndrome or toxic epidermal necrolysis. Most (92.1%) of the ADRs resolved or improved. Glycated hemoglobin, fasting blood glucose, body weight, and systolic blood pressure decreased by 0.6% (baseline 7.8%), 22.7 mg/dL (baseline 163.0 mg/dL), 2.3 kg (baseline 67.4 kg), and 3.1 mmHg (baseline 133.2 mmHg), respectively, from baseline to treatment discontinuation/last visit.
  
  
  CONCLUSIONS
  Ipragliflozin is well tolerated and reduced surrogate endpoints in elderly Japanese patients with type 2 diabetes mellitus. Clinicaltrials.gov identifier: NCT02297620.
authors.affiliation: a Yokohama City University Graduate School of Medicine , Yokohama , Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Terauchi
authors.affiliation: b Chiba University Graduate School of Medicine , Chiba , Japan.
authors.forename: Koutaro
authors.initials: K
authors.lastname: Yokote
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; D001786:Blood Glucose / Q000032:analysis; D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005960:Glucosides / Q000009:adverse effects*; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000453:epidemiology; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D015994:Incidence; D011358:Product Surveillance, Postmarketing; D011795:Surveys and Questionnaires; D013876:Thiophenes / Q000009:adverse effects*
chemical_list: D001786:Blood Glucose; D005960:Glucosides; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D013876:Thiophenes; C572941:ipragliflozin
keywords: SGLT2 inhibitors; elderly; ipragliflozin; post-marketing surveillance; type 2 diabetes mellitus