title: Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study.
abstract: OBJECTIVE
  To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM).
  
  
  METHODS
  This multicenter, single-arm, 6 month, observational, prospective cohort study was conducted at 39 centers across Turkey. T2DM patients on vildagliptin and metformin for ≤4 weeks were enrolled regardless of their previous antidiabetic therapy.
  
  
  METHODS
  Efficacy was evaluated by measuring hemoglobin A1c (HbA1c) levels. Tolerability/safety parameters evaluated included hypoglycemic events, gastrointestinal events, peripheral edema and weight gain.
  
  
  RESULTS
  This study enrolled 665 patients with a mean ± standard deviation (SD) age of 55.1 ± 10.2 years and female predominance (n = 394, 59.2%). Safety was assessed in all enrolled patients. Hypoglycemia was reported in 10 (1.5%) patients (95% confidence interval = 0.8-2.7%). Efficacy was assessed in 289 (43.5%) patients treated for 6 ± 1 months; these patients showed a mean decrease in HbA1c of 0.8% from baseline value of 7.8% (p < 0.001). The percentages of patients who achieved HbA1c targets of ≤6.5% and ≤7.0% were significantly increased, from 10.7% to 33.6% and from 22.1% to 52.6%, respectively (p < 0.001 each). The decrease in HbA1c was independent of baseline HbA1c (≤8% vs. 8-10% vs. ≥10%), age (≤65 vs. >65 years) and body mass index (<30 vs. ≥30 kg/m(2)) (p < 0.001 each). In total, 136 adverse events (AEs) were observed in 71 (10.7%) patients; 10 (1.5%) patients experienced hypoglycemia and gastrointestinal AEs were most commonly reported (n = 29, 4.4%).
  
  
  CONCLUSIONS
  In a 'real-life' setting, the vildagliptin and metformin combination was associated with significant improvements in reaching target HbA1c levels, even in elderly and obese patients with T2DM. Moreover, vildagliptin and metformin demonstrated a good overall tolerability/safety profile.
authors.affiliation: Gazi University School of Medicine , Ankara , Turkey.
authors.forename: Goksun
authors.initials: G
authors.lastname: Ayvaz
authors.forename: Lezzan
authors.initials: L
authors.lastname: Keskin
authors.forename: Fulya
authors.initials: F
authors.lastname: Akin
authors.forename: Hatice Sebile
authors.initials: HS
authors.lastname: Dokmetas
authors.forename: Ertugrul
authors.initials: E
authors.lastname: Tasan
authors.forename: Idilhan Baloglu
authors.initials: IB
authors.lastname: Ar
authors.forename: Emel
authors.initials: E
authors.lastname: Uren
mesh_terms: D000218:Adamantane / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D015992:Body Mass Index; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000188:drug therapy; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000008:administration & dosage / Q000009:adverse effects; D016903:Drug Monitoring; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000517:prevention & control; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D008297:Male; D008687:Metformin / Q000008:administration & dosage / Q000009:adverse effects; D008875:Middle Aged; D009570:Nitriles / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D011759:Pyrrolidines / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014421:Turkey; D000077597:Vildagliptin
chemical_list: D000218:Adamantane; D054873:Dipeptidyl-Peptidase IV Inhibitors; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D008687:Metformin; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin
keywords: DPP-4; HbA1c; Real-life; Type 2 diabetes; Vildagliptin