PMID- 25697921
OWN - NLM
STAT- MEDLINE
DCOM- 20150812
LR  - 20221207
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 31
IP  - 4
DP  - 2015 Apr
TI  - Real-life safety and efficacy of vildagliptin as add-on to metformin in patients 
      with type 2 diabetes in Turkey--GALATA study.
PG  - 623-32
LID - 10.1185/03007995.2015.1019609 [doi]
AB  - 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). RESEARCH DESIGN AND 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. MAIN OUTCOME 
      MEASURES: 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.
FAU - Ayvaz, Goksun
AU  - Ayvaz G
AD  - Gazi University School of Medicine , Ankara , Turkey.
FAU - Keskin, Lezzan
AU  - Keskin L
FAU - Akin, Fulya
AU  - Akin F
FAU - Dokmetas, Hatice Sebile
AU  - Dokmetas HS
FAU - Tasan, Ertugrul
AU  - Tasan E
FAU - Ar, Idilhan Baloglu
AU  - Ar IB
FAU - Uren, Emel
AU  - Uren E
CN  - GALATA Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20150316
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Dipeptidyl-Peptidase IV Inhibitors)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Nitriles)
RN  - 0 (Pyrrolidines)
RN  - 9100L32L2N (Metformin)
RN  - I6B4B2U96P (Vildagliptin)
RN  - PJY633525U (Adamantane)
SB  - IM
MH  - Adamantane/administration & dosage/adverse effects/*analogs & derivatives
MH  - Body Mass Index
MH  - Cohort Studies
MH  - Diabetes Mellitus, Type 2/diagnosis/drug therapy
MH  - Dipeptidyl-Peptidase IV Inhibitors/administration & dosage/adverse effects
MH  - Drug Monitoring
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - *Hypoglycemia/chemically induced/prevention & control
MH  - Hypoglycemic Agents/therapeutic use
MH  - Male
MH  - *Metformin/administration & dosage/adverse effects
MH  - Middle Aged
MH  - *Nitriles/administration & dosage/adverse effects
MH  - Prospective Studies
MH  - *Pyrrolidines/administration & dosage/adverse effects
MH  - Treatment Outcome
MH  - Turkey
MH  - Vildagliptin
OTO - NOTNLM
OT  - DPP-4
OT  - HbA1c
OT  - Real-life
OT  - Type 2 diabetes
OT  - Vildagliptin
FIR - Akber, Tarik
IR  - Akber T
FIR - Akdeniz, Yasemin
IR  - Akdeniz Y
FIR - Akin, Taner Fulya
IR  - Akin TF
FIR - Ayvaz, Goksun
IR  - Ayvaz G
FIR - Bambul, Nail
IR  - Bambul N
FIR - Bayraktaroglu, Taner
IR  - Bayraktaroglu T
FIR - Borlu, Fatih
IR  - Borlu F
FIR - Boz, Mustafa
IR  - Boz M
FIR - Bozoglu, Ergun
IR  - Bozoglu E
FIR - Buyukbese, Mehmet Akif
IR  - Buyukbese MA
FIR - Canberk, Aykan
IR  - Canberk A
FIR - Comlekci, Abdurrahman
IR  - Comlekci A
FIR - Delibasi, Tuncay
IR  - Delibasi T
FIR - Demir, Serap
IR  - Demir S
FIR - Dokmetas, Hatice Sebile
IR  - Dokmetas HS
FIR - Eskioglu, Erdal
IR  - Eskioglu E
FIR - Guler, Serdar
IR  - Guler S
FIR - Gulkan, Serpil
IR  - Gulkan S
FIR - Hekimsoy, Zeliha
IR  - Hekimsoy Z
FIR - Karaca, Zuhal
IR  - Karaca Z
FIR - Keskin, Lezzan
IR  - Keskin L
FIR - Keskin, Muge
IR  - Keskin M
FIR - Koca, Nizameddin
IR  - Koca N
FIR - Korkmaz, Hakan
IR  - Korkmaz H
FIR - Onder, Elif
IR  - Onder E
FIR - Ozisik, Lale
IR  - Ozisik L
FIR - Peru, Celalettin
IR  - Peru C
FIR - Sahin, Mustafa
IR  - Sahin M
FIR - Saygili, Fusun
IR  - Saygili F
FIR - Serin, Sibel
IR  - Serin S
FIR - Sezer, Havva
IR  - Sezer H
FIR - Sezgin, Gulbuz
IR  - Sezgin G
FIR - Tasan, Ertugrul
IR  - Tasan E
FIR - Tasci, Ilker
IR  - Tasci I
FIR - Tasliyurt, Turker
IR  - Tasliyurt T
FIR - Torun, Ayse Nur
IR  - Torun AN
FIR - Tura Behadir, Cigdem
IR  - Tura Behadir C
FIR - Gursoy Yener, Gul
IR  - Gursoy Yener G
FIR - Yigit, Zerrin
IR  - Yigit Z
EDAT- 2015/02/24 06:00
MHDA- 2015/08/13 06:00
CRDT- 2015/02/21 06:00
PHST- 2015/02/21 06:00 [entrez]
PHST- 2015/02/24 06:00 [pubmed]
PHST- 2015/08/13 06:00 [medline]
AID - 10.1185/03007995.2015.1019609 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2015 Apr;31(4):623-32. doi: 10.1185/03007995.2015.1019609. 
      Epub 2015 Mar 16.