title: Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment Persistence and Safety from the 2-Year Real-Life VILDA Study.
abstract: BACKGROUND
  There is an increasing interest for real-life data on drug use in many countries. Reimbursement authorities more and more request observational studies to assess the conditions of use of the products but also to improve knowledge about efficacy and safety in the real world and on a longer term than in clinical trials.
  
  
  OBJECTIVE
  To evaluate the effectiveness, treatment persistence and tolerability of vildagliptin in clinical practice.
  
  
  METHODS
  This observational, 2-year prospective cohort study was conducted in France on request of the Health Authorities [Haute Autorite de Sante (HAS)]. Type 2 diabetic mellitus (T2DM) patients initiating vildagliptin (including the fixed combination vildagliptin-metformin) or treated for <6 months were recruited through a national representative sample of general practitioners (GPs) (n = 482) and diabetologists (n = 84) between March 2010 and December 2011. At inclusion and each follow-up visit at ~ 6, 12, 18 and 24 months, a questionnaire was completed by the physician collecting information on socio-demographic, clinical and biological data, treatments and adverse events.
  
  
  RESULTS
  1,700 patients were included: 60% were males, aged 63 ± 11 years, with diabetes duration 7 ± 6 years and body mass index (BMI) 30 ± 6 kg/m(2). 45% were obese, 70% treated for hypertension and 66% for dyslipidemia. 64% of the patients received vildagliptin in dual therapy with metformin. 82% of patients completed the 2-year follow-up. Glycosylated hemoglobin (HbA1c) decreased from a mean baseline of 7.8 ± 1.2% when vildagliptin was started, to 7.0 ± 1.1% at 6 months and remained stable thereafter over 2 years. Mean weight, glomerular filtration rate, liver enzymes, and lipid parameters were unchanged over the study period. Eight patients (0.5%), all concomitantly treated with insulin and/or sulphonylureas, reported one severe hypoglycemia and 47 (2.9%) patients reported 64 non-severe symptomatic hypoglycemia (59% occurred when patients were treated with insulin and/or sulphonylureas). At 6 months, 44.9% of vildagliptin-treated patients reached an HbA1c <7% without hypoglycemia and no weight gain, and this percentage increased to 49.7% at 24 months. Vildagliptin treatment maintenance at 2 years was 88.8% [95% CI (87.2%; 90.4%)], with 4% of patients discontinuing for adverse events.
  
  
  CONCLUSIONS
  In everyday conditions of care, vildagliptin efficacy was in line with existing data from randomized clinical trials, sustained over 2 years, with low discontinuation rate and low hypoglycemia risk.
authors.affiliation: Diabetes Department, Pitié-Salpétrière Hospital, and Pierre et Marie Curie University, Paris, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Simon
authors.forename: Bruno
authors.initials: B
authors.lastname: Detournay
authors.forename: Evelyne
authors.initials: E
authors.lastname: Eschwege
authors.forename: Stephane
authors.initials: S
authors.lastname: Bouée
authors.forename: Jacques
authors.initials: J
authors.lastname: Bringer
authors.forename: Claude
authors.initials: C
authors.lastname: Attali
authors.forename: Sylvie
authors.initials: S
authors.lastname: Dejager
references.citation: Diabetes Metab. 2012 Dec;38(6):550-7
references.pmid: 22996038
references.citation: Adv Ther. 2013 Feb;30(2):152-64
references.pmid: 23430354
references.citation: Hosp Pract (1995). 2012 Apr;40(2):7-21
references.pmid: 22615074
references.citation: Diabetes Care. 2011 Jun;34(6):1249-57
references.pmid: 21617109
references.citation: Diabetes Res Clin Pract. 2010 Mar;87(3):293-301
references.pmid: 20171754
references.citation: Hosp Pract (1995). 2013 Apr;41(2):93-107
references.pmid: 23680741
references.citation: Diabet Med. 2012 Mar;29(3):293-302
references.pmid: 21838763
references.citation: Horm Metab Res. 2008 Jun;40(6):427-30
references.pmid: 18401832
references.citation: Diabetes Res Clin Pract. 2014 Feb;103(2):206-17
references.pmid: 24300019
references.citation: Horm Metab Res. 2007 Mar;39(3):218-23
references.pmid: 17373638
references.citation: PLoS One. 2012;7(3):e32412
references.pmid: 22403654
references.citation: Diabet Med. 2007 Sep;24(9):955-61
references.pmid: 17509069
references.citation: Diabetes Res Clin Pract. 2007 Apr;76(1):132-8
references.pmid: 17223217
references.citation: Presse Med. 2013 May;42(5):830-8
references.pmid: 23566620
references.citation: Diabetes Obes Metab. 2011 Sep;13(9):775-83
references.pmid: 21507182
references.citation: Diabetes Care. 2007 Dec;30(12):3017-22
references.pmid: 17878242
references.citation: Diabetes Obes Metab. 2014 May;16(5):403-9
references.pmid: 24199686
references.citation: Diabetes Care. 2013 Aug;36(8):2430-9
references.pmid: 23788649
references.citation: Hosp Pract (1995). 2011 Feb;39(1):7-21
references.pmid: 21441754
references.citation: Diabetes Care. 1999 Mar;22(3):530-2
references.pmid: 10097946
references.citation: Diabetes Metab. 2012 Mar;38 Suppl 3:S36-46
references.pmid: 22541601
references.citation: BMJ. 2013 Jul 29;347:f4533
references.pmid: 23900314
references.citation: Diabetes Obes Metab. 2010 Sep;12(9):780-9
references.pmid: 20649630
references.citation: Diabet Med. 2011 May;28(5):583-9
references.pmid: 21294766
references.citation: Diabetes Metab. 2012 Oct;38(4):343-51
references.pmid: 22521038
references.citation: Rev Med Liege. 2010 Mar;65(3):127-32
references.pmid: 20411816
references.citation: Diabetes Care. 2005 Apr;28(4):838-43
references.pmid: 15793182
references.citation: Int J Clin Pract. 2013 Oct;67(10):947-56
references.pmid: 23961850
references.citation: Diabetes Obes Metab. 2009 Feb;11(2):157-66
references.pmid: 19125777
references.citation: Vasc Health Risk Manag. 2012;8:339-48
references.pmid: 22661900
references.citation: Diabet Med. 2010 Mar;27(3):309-17
references.pmid: 20536494
references.citation: Diabetes Obes Metab. 2013 Mar;15(3):252-7
references.pmid: 23039321
references.citation: Diabetes Care. 2007 Apr;30(4):890-5
references.pmid: 17277036
references.citation: Diabetes Obes Metab. 2013 Jan;15(1):55-61
references.pmid: 22862879
references.citation: Curr Med Res Opin. 2010 Jul;26(7):1647-56
references.pmid: 20441397
references.citation: Diabetes Ther. 2012 Nov;3(1):8
references.pmid: 22736406
references.citation: Vasc Health Risk Manag. 2013;9:21-8
references.pmid: 23378769
references.citation: Diabetes Metab. 2011 Apr;37(2):152-61
references.pmid: 21435929
references.citation: Diabetes Ther. 2013 Dec;4(2):257-67
references.pmid: 23821355
references.citation: Diabetes Obes Metab. 2011 Jan;13(1):55-64
references.pmid: 21114604
references.citation: Diabetes Care. 2012 Jun;35(6):1364-79
references.pmid: 22517736
references.citation: Curr Med Res Opin. 2014 May;30(5):785-9
references.pmid: 24328429
references.citation: Diabetologia. 2007 Jun;50(6):1148-55
references.pmid: 17387446
references.citation: J Clin Endocrinol Metab. 2009 Apr;94(4):1236-43
references.pmid: 19174497
references.citation: J Diabetes Complications. 2012 Sep-Oct;26(5):399-406
references.pmid: 22699113
references.citation: Vasc Health Risk Manag. 2013;9:57-64
references.pmid: 23431062
references.citation: Horm Metab Res. 2008 Dec;40(12):892-5
references.pmid: 18726829
references.citation: Diabetes Ther. 2011 May;2(2):51-66
references.pmid: 22127800
references.citation: Vasc Health Risk Manag. 2013;9:155-63
references.pmid: 23637538