title: Efficacy and tolerability of vildagliptin-based versus comparative dual therapy in type 2 diabetes : Results of the Austrian subpopulation of the EDGE study.
abstract: BACKGROUND
  The aim of this post hoc analysis of data from the Austrian subpopulation of the EDGE study was the evaluation of the effectiveness and tolerability of vildagliptin as an add-on to an existing oral antidiabetic (OAD) monotherapy versus a combination therapy with two OADs without vildagliptin in patients with inadequately controlled type 2 diabetes.
  
  
  METHODS
  In Austria, 422 patients were included. In the framework of regular visits (at baseline, about once per quarter, and at the study end, after 12 months), adverse events (AEs), courses, and changes of therapy were recorded. In addition to the primary end point defined in the primary study, i.e., a reduction of HbA1c by > 0.3 % without hypoglycemia, weight gain ≥ 5 %, peripheral edema, or discontinuation due to gastrointestinal events, the most clinically relevant secondary end point, i.e., HbA1c reduction < 7 % without hypoglycemia or ≥ 3 % increase in body weight after 12 months was used for the analysis of the Austrian data.
  
  
  RESULTS
  The initial HbA1c of all enrolled patients was 8.3 ± 1.4 %. The mean reduction of HbA1c was - 1.1 % in the vildagliptin cohort and - 1.0 % in the comparator cohort. In the vildagliptin cohort, 56.4 % of patients, and in the comparator cohort, 45.9 % of patients, reached the primary end point (odds ratio: 1.53, p = 0.04). In the vildagliptin cohort, 18.7 % of patients, and in the comparator cohort, 16.9 % of patients, reached the secondary end point (odds ratio: 1.13, p = 0.68). The incidence of hypoglycemic events (two in each cohort), AEs (approximately 15 % in each cohort), and serious AEs (approximately 2 % in each cohort) was comparable between the two groups.
  
  
  CONCLUSIONS
  In a "real-life" setting, the effectiveness of vildagliptin as second-line treatment is superior to comparator OADs with regard to a reduction in HbA1c of greater than 0.3 % from baseline without well-recognized side effects in patients with inadequately controlled type 2 diabetes (mean baseline HbA1c: 8.5 % (vildagliptin cohort) vs. 8.1 % (comparator cohort)).
authors.affiliation: Diabetes Outpatient Clinic, Health Center South, Wienerbergstr. 13, 1100, Vienna, Austria, helmut.brath@wgkk.at.
authors.forename: Helmut
authors.initials: H
authors.lastname: Brath
authors.forename: Christoph
authors.initials: C
authors.lastname: Bialek
authors.forename: Ewald
authors.initials: E
authors.lastname: Gingl
authors.forename: Michael
authors.initials: M
authors.lastname: Resl
authors.forename: Rudolf
authors.initials: R
authors.lastname: Prager
authors.forename: Michaela
authors.initials: M
authors.lastname: Ratzinger
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000284:Administration, Oral; D001317:Austria / Q000453:epidemiology; D015415:Biomarkers / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D004359:Drug Therapy, Combination / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage*; D015995:Prevalence; D011759:Pyrrolidines / Q000008:administration & dosage*; D016896:Treatment Outcome; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D015415:Biomarkers; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human