title: Effectiveness of vildagliptin versus other oral antidiabetes drugs as add-on to sulphonylurea monotherapy: Post hoc analysis from the EDGE study.
abstract: In this post hoc analysis of the EDGE study, we assessed the effectiveness and safety of vildagliptin versus other oral antidiabetes drugs (OADs) as add-on to first-line sulphonylurea (SU) therapy in patients who did not receive metformin in a real-life setting.
  
  
  
  The primary endpoint was odds of achieving an HbA1c reduction of >0.3% without tolerability issues. Secondary endpoint was odds of achieving HbA1c <7.0% without hypoglycaemia or weight gain. Changes in HbA1c, body weight; and safety were also assessed.
  
  
  
  2936 patients received vildagliptin and 820 received comparator OADs (any α-GI, TZD, glinide) as add-on to first-line SU therapy. Overall, the mean age, disease duration, HbA1c, and BMI at baseline were 57.1 years, 6.3 years, 8.5%, and 27.7kg/m2, respectively. The odds ratios for achieving primary and secondary endpoints were 1.6 (95% CI: 1.36, 1.86; p<0.0001) and 1.8 (1.45, 2.21; p<0.0001), respectively, in favour of vildagliptin. The between-treatment differences (vildagliptin vs. comparator OAD) for the mean change in HbA1c and body weight were -0.2±0.04% (p<0.0001) and -0.8±0.16kg (p<0.0001), respectively. Overall, the incidence of adverse events was low (vildagliptin, 7% vs. comparator, 8.2%) in both groups. Similar results were observed in a subset of patients enrolled from India and patients who received TZDs as a comparator OAD.
  
  
  
  Under real-life settings, vildagliptin as add-on to SU monotherapy showed better glycaemic response without tolerability issues compared with other OADs.
authors.affiliation: Center for Diabetes and Endocrine Care, Bangalore, India.
authors.forename: K M
authors.initials: KM
authors.lastname: Prasanna Kumar
authors.affiliation: Institute for Training and Research in Diabetes and Endocrinology, Pune, India.
authors.forename: U
authors.initials: U
authors.lastname: Phadke
authors.affiliation: Health Center South, Vienna, Austria.
authors.forename: H
authors.initials: H
authors.lastname: Brath
authors.affiliation: Novartis Healthcare Private Limited, Mumbai, India.
authors.forename: A
authors.initials: A
authors.lastname: Gawai
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: P M
authors.initials: PM
authors.lastname: Paldánius
authors.affiliation: Katholieke Universiteit Leuven, UZ Herestraat 49, Leuven 3000, Belgium. Electronic address: chantal.mathieu@uz.kuleuven.ac.be.
authors.forename: C
authors.initials: C
authors.lastname: Mathieu
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007194:India; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009570:Nitriles / Q000008:administration & dosage* / Q000009:adverse effects; D016017:Odds Ratio; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage* / Q000009:adverse effects; D012307:Risk Factors; D013453:Sulfonylurea Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D000077597:Vildagliptin; D015430:Weight Gain / Q000187:drug effects
chemical_list: D000218:Adamantane; D015415:Biomarkers; D001786:Blood Glucose; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D013453:Sulfonylurea Compounds; D000077597:Vildagliptin; C517652:hemoglobin A1c protein, human
keywords: India; Real-life setting; Sulphonylurea; Vildagliptin