title: Saxagliptin efficacy and safety in patients with type 2 diabetes receiving concomitant statin therapy.
abstract: OBJECTIVE
  To examine whether concomitant statin therapy affects glycemic control with saxagliptin 2.5 and 5mg/d in patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  Efficacy and safety were analyzed post hoc for pooled data from 9 saxagliptin randomized, placebo-controlled trials with a primary 24-week treatment period (4 monotherapy, 2 add-on to metformin, 1 each add-on to a sulfonylurea, thiazolidinedione, or insulin±metformin). Safety was also assessed in an 11-study, 24-week pool and an extended 20-study pool, which included 9 additional 4- to 52-week randomized studies. Comparisons were performed for patient groups defined by baseline statin use.
  
  
  RESULTS
  Saxagliptin produced greater mean reductions in glycated hemoglobin than placebo, with no interaction between treatment and baseline statin use (P=0.47). In patients receiving saxagliptin 2.5 and 5mg and placebo, the proportion of patients with ≥1 adverse event (AE) was 78.1%, 64.0%, and 63.2%, respectively, in patients with any statin use and 70.6%, 57.9%, and 55.0% in patients with no statin use. Serious AEs, deaths, and symptomatic confirmed hypoglycemia (fingerstick glucose ≤50mg/dL) were few and similar, irrespective of baseline statin use.
  
  
  CONCLUSIONS
  Saxagliptin improves glycemic control and is generally well tolerated in patients with T2DM, irrespective of concomitant statin therapy.
authors.affiliation: AstraZeneca, Wilmington, DE, USA. Electronic address: brian.bryzinski@astrazeneca.com.
authors.forename: Brian
authors.initials: B
authors.lastname: Bryzinski
authors.affiliation: Novo Nordisk, New York, NY, USA.
authors.forename: Elsie
authors.initials: E
authors.lastname: Allen
authors.affiliation: AstraZeneca, Wilmington, DE, USA.
authors.forename: William
authors.initials: W
authors.lastname: Cook
authors.affiliation: AstraZeneca, Wilmington, DE, USA.
authors.forename: Boaz
authors.initials: B
authors.lastname: Hirshberg
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000368:Aged; D017326:Clinical Trials, Phase III as Topic / Q000706:statistics & numerical data; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology; D004151:Dipeptides / Q000008:administration & dosage* / Q000009:adverse effects*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects*; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D016896:Treatment Outcome
chemical_list: D004151:Dipeptides; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D007004:Hypoglycemic Agents; C502994:saxagliptin; D000218:Adamantane
keywords: Cardiovascular disease; Dipeptidyl peptidase-4 inhibitor; Dyslipidemia; Incretin; Statin