title: Saxagliptin for the treatment of diabetes - a focus on safety.
abstract: BACKGROUND
  The safety of agents used to treat type 2 diabetes (T2D), a chronic disease requiring life-long intervention, is of particular interest. Saxagliptin is a potent and selective DPP-4 inhibitor that has emerged as a therapeutic option for T2D.
  
  
  METHODS
  Its safety was assessed in a development program of 20 phase 2/3 randomized clinical trials and in SAVOR-TIMI 53 trial that evaluated the cardiovascular outcomes. In order to capture any further safety signals, mainly in the long-term, a post-marketing safety surveillance is ongoing. This paper discusses the tolerability and safety profile of the agent, including cardiovascular, renal, pancreatic, hepatic and bone adverse events.
  
  
  CONCLUSIONS
  Saxagliptin is a safe therapeutic option for patients with T2D, with low risk of hypoglycemia and good tolerability. It demonstrated cardiovascular safety (including in patients with pre-existing cardiovascular disease and/or HF) and safety with respect to all-cause mortality and adverse events of special interest. In SAVOR-TIMI53, saxagliptin was associated with an unexpected increased risk of HF hospitalization, mainly in the first 12 months; a mechanistic explanation for this has not been found. Further research needs to elucidate the effect of antidiabetic drugs on the heart, by including biomarkers and echocardiographic sub-studies within large outcome trials.
authors.affiliation: a Department M3/Internal Medicine IV , University of Medicine and Pharmacy , Târgu Mureş , Romania.|b Diabetes, Nutrition and Metabolic Diseases , Emergency County Clinical Hospital , Târgu Mureş , Romania.
authors.forename: Simona
authors.initials: S
authors.lastname: Cernea
authors.affiliation: c Diabetes Unit, Department of Internal Medicine , Hadassah Hebrew University Hospital , Jerusalem , Israel.
authors.forename: Avivit
authors.initials: A
authors.lastname: Cahn
authors.affiliation: c Diabetes Unit, Department of Internal Medicine , Hadassah Hebrew University Hospital , Jerusalem , Israel.
authors.forename: Itamar
authors.initials: I
authors.lastname: Raz
mesh_terms: D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic
chemical_list: D004151:Dipeptides; D054873:Dipeptidyl-Peptidase IV Inhibitors; D007004:Hypoglycemic Agents; C502994:saxagliptin; D000218:Adamantane
keywords: DPP-4 inhibitors; Saxagliptin; cardiovascular outcomes; safety profile