title: Efficacy and safety of saxagliptin in older patients with type 2 diabetes mellitus.
abstract: OBJECTIVE
  To assess the safety and efficacy of saxagliptin (5 mg once-daily) in older patients (≥65 years of age) with inadequately controlled type 2 diabetes.
  
  
  METHODS
  In this retrospective subgroup analysis, data from five randomized, double-blind, placebo-controlled, multicenter, 24-week, phase 3 trials were included. The primary studies evaluated saxagliptin 5 mg once-daily (monotherapy or add-on) in patients aged 18-77 years with HbA(1c) ≥7.0% (four studies) or ≥7.5% (add-on to glyburide study) versus placebo.
  
  
  METHODS
  The primary efficacy endpoint of each study included in this pooled analysis was HbA(1c) change from baseline to week 24.
  
  
  RESULTS
  In the five-study pooled population, 279 (16.6%) patients were at least 65 years old; 142 received saxagliptin 5 mg once-daily and 137 received placebo. Treatment groups were well-balanced for baseline characteristics within each study. In older patients, the HbA(1c) adjusted mean change from a baseline of 8.1% was -0.73 ± 0.16% (mean ± SEM) with saxagliptin compared with -0.17 ± 0.14% for placebo from a baseline of 8.0%. Adverse event rates were similar with saxagliptin 5 mg once-daily compared with placebo in older patients.
  
  
  CONCLUSIONS
  The pooled subgroup analysis of saxagliptin 5 mg once-daily monotherapy and add-on therapy trials demonstrated clinically relevant and significant efficacy for reducing HbA(1c) in older (≥65 years) patients. Saxagliptin was well-tolerated in older patients with a low incidence of hypoglycemia and no weight gain.
authors.affiliation: Rouen University Hospital, Rouen, France. Jean.Doucet@chu-rouen.fr
authors.forename: Jean
authors.initials: J
authors.lastname: Doucet
authors.forename: Antonio
authors.initials: A
authors.lastname: Chacra
authors.forename: Pierre
authors.initials: P
authors.lastname: Maheux
authors.forename: Jane
authors.initials: J
authors.lastname: Lu
authors.forename: Susan
authors.initials: S
authors.lastname: Harris
authors.forename: Julio
authors.initials: J
authors.lastname: Rosenstock
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004151:Dipeptides / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004151:Dipeptides; D007004:Hypoglycemic Agents; D010919:Placebos; C502994:saxagliptin; D000218:Adamantane