title: Safety of saxagliptin: events of special interest in 9156 patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  A post hoc pooled analysis was undertaken to evaluate the safety of saxagliptin in patients with type 2 diabetes mellitus, with attention to events of special interest for dipeptidyl peptidase-4 inhibitors.
  
  
  METHODS
  Pooled analyses were performed for 20 randomized controlled studies (N = 9156) of saxagliptin as monotherapy or add-on therapy, and a subset of 11 saxagliptin + metformin studies. Adverse events and events of special interest (gastrointestinal adverse events, infections, hypersensitivity, pancreatitis, skin lesions, lymphopenia, thrombocytopenia, hypoglycaemia, bone fracture, severe cutaneous adverse reactions, opportunistic infection, angioedema, malignancy, worsening renal function, and specific laboratory events) were assessed; incidence rates (events/100 person-years) and incidence rates ratios (saxagliptin/control) were calculated (Mantel-Haenszel method).
  
  
  RESULTS
  In both pooled datasets, the incidence rates for deaths, serious adverse events, discontinuations due to adverse events, pancreatitis, malignancy, and most other events of special interest, excepting bone fractures and hypersensitivity, were similar between treatments, with 95% confidence intervals (CIs) for incidence rates ratios including 1. In the 20-study pool, the incidence rates per 100 person-years was higher with saxagliptin versus control for bone fractures [1.1 vs 0.6; incidence rates ratio (95% CI), 1.81 (1.04-3.28)] and hypersensitivity adverse events [1.3 vs 0.8; 1.67 (1.01-2.87)].
  
  
  CONCLUSIONS
  Pooled data from 20 studies confirm that saxagliptin has a favourable safety and benefit-risk profile.
authors.affiliation: AstraZeneca, Wilmington, DE, USA.
authors.forename: Boaz
authors.initials: B
authors.lastname: Hirshberg
authors.forename: Artist
authors.initials: A
authors.lastname: Parker
authors.forename: Helen
authors.initials: H
authors.lastname: Edelberg
authors.forename: Mark
authors.initials: M
authors.lastname: Donovan
authors.forename: Nayyar
authors.initials: N
authors.lastname: Iqbal
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004151:Dipeptides / Q000009:adverse effects* / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D054795:Incretins / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D016896:Treatment Outcome
chemical_list: D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D054795:Incretins; C502994:saxagliptin; D000218:Adamantane
keywords: adverse events; dipeptidyl peptidase-4 inhibitor; hypoglycaemia; incretin; saxagliptin; type 2 diabetes mellitus