PMID- 24729158
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140622
LR  - 20211021
IS  - 1869-6953 (Print)
IS  - 1869-6961 (Electronic)
IS  - 1869-6961 (Linking)
VI  - 5
IP  - 1
DP  - 2014 Jun
TI  - Use of Vildagliptin in Management of Type 2 Diabetes: Effectiveness, Treatment 
      Persistence and Safety from the 2-Year Real-Life VILDA Study.
PG  - 207-24
LID - 10.1007/s13300-014-0064-0 [doi]
AB  - INTRODUCTION: 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. AIM: 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.
FAU - Simon, Dominique
AU  - Simon D
AD  - Diabetes Department, Pitie-Salpetriere Hospital, and Pierre et Marie Curie 
      University, Paris, France.
FAU - Detournay, Bruno
AU  - Detournay B
FAU - Eschwege, Evelyne
AU  - Eschwege E
FAU - Bouee, Stephane
AU  - Bouee S
FAU - Bringer, Jacques
AU  - Bringer J
FAU - Attali, Claude
AU  - Attali C
FAU - Dejager, Sylvie
AU  - Dejager S
LA  - eng
PT  - Journal Article
DEP - 20140412
PL  - United States
TA  - Diabetes Ther
JT  - Diabetes therapy : research, treatment and education of diabetes and related 
      disorders
JID - 101539025
PMC - PMC4065290
EDAT- 2014/04/15 06:00
MHDA- 2014/04/15 06:01
PMCR- 2014/04/12
CRDT- 2014/04/15 06:00
PHST- 2014/02/17 00:00 [received]
PHST- 2014/04/15 06:00 [entrez]
PHST- 2014/04/15 06:00 [pubmed]
PHST- 2014/04/15 06:01 [medline]
PHST- 2014/04/12 00:00 [pmc-release]
AID - 64 [pii]
AID - 10.1007/s13300-014-0064-0 [doi]
PST - ppublish
SO  - Diabetes Ther. 2014 Jun;5(1):207-24. doi: 10.1007/s13300-014-0064-0. Epub 2014 
      Apr 12.