PMID- 25576329
OWN - NLM
STAT- MEDLINE
DCOM- 20160209
LR  - 20221207
IS  - 1613-7671 (Electronic)
IS  - 0043-5325 (Linking)
VI  - 127
IP  - 7-8
DP  - 2015 Apr
TI  - Efficacy and tolerability of vildagliptin-based versus comparative dual therapy 
      in type 2 diabetes : Results of the Austrian subpopulation of the EDGE study.
PG  - 250-5
LID - 10.1007/s00508-014-0646-x [doi]
AB  - 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. PATIENTS AND 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. CONCLUSION: 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)).
FAU - Brath, Helmut
AU  - Brath H
AD  - Diabetes Outpatient Clinic, Health Center South, Wienerbergstr. 13, 1100, Vienna, 
      Austria, helmut.brath@wgkk.at.
FAU - Bialek, Christoph
AU  - Bialek C
FAU - Gingl, Ewald
AU  - Gingl E
FAU - Resl, Michael
AU  - Resl M
FAU - Prager, Rudolf
AU  - Prager R
FAU - Ratzinger, Michaela
AU  - Ratzinger M
LA  - eng
PT  - Controlled Clinical Trial
PT  - Journal Article
DEP - 20150110
PL  - Austria
TA  - Wien Klin Wochenschr
JT  - Wiener klinische Wochenschrift
JID - 21620870R
RN  - 0 (Biomarkers)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 0 (hemoglobin A1c protein, human)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/*analogs & derivatives
MH  - Administration, Oral
MH  - Austria/epidemiology
MH  - Biomarkers/blood
MH  - Diabetes Mellitus, Type 2/diagnosis/*drug therapy/*epidemiology
MH  - Drug Therapy, Combination/methods
MH  - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Nitriles/*administration & dosage
MH  - Prevalence
MH  - Pyrrolidines/*administration & dosage
MH  - Treatment Outcome
MH  - Vildagliptin
EDAT- 2015/01/13 06:00
MHDA- 2016/02/10 06:00
CRDT- 2015/01/11 06:00
PHST- 2013/11/09 00:00 [received]
PHST- 2014/10/14 00:00 [accepted]
PHST- 2015/01/11 06:00 [entrez]
PHST- 2015/01/13 06:00 [pubmed]
PHST- 2016/02/10 06:00 [medline]
AID - 10.1007/s00508-014-0646-x [doi]
PST - ppublish
SO  - Wien Klin Wochenschr. 2015 Apr;127(7-8):250-5. doi: 10.1007/s00508-014-0646-x. 
      Epub 2015 Jan 10.