Please use this identifier to cite or link to this item: https://hdl.handle.net/11499/10532
Title: Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study
Authors: Ayvaz, G.
Keskin, L.
Akın, Fulya
Dokmetas, H.S.
Tasan, E.
Ar, I.B.
Uren, E.
Keywords: DPP-4
HbA1c
Real-life
Type 2 diabetes
Vildagliptin
hemoglobin A1c
liver enzyme
metformin
vildagliptin
adamantane
antidiabetic agent
dipeptidyl peptidase IV inhibitor
glycosylated hemoglobin
nitrile
pyrrolidine derivative
add on therapy
adult
Article
body mass
constipation
diarrhea
drug efficacy
drug safety
drug tolerability
eye disease
female
gastrointestinal symptom
heart disease
human
hypoglycemia
kidney disease
major clinical study
male
mental disease
metabolic disorder
middle aged
multicenter study
nausea
non insulin dependent diabetes mellitus
peripheral edema
skin manifestation
Turkey (republic)
vascular disease
weight reduction
analogs and derivatives
chemically induced
clinical trial
cohort analysis
Diabetes Mellitus, Type 2
drug combination
drug monitoring
prospective study
treatment outcome
Turkey
Adamantane
Body Mass Index
Cohort Studies
Dipeptidyl-Peptidase IV Inhibitors
Drug Monitoring
Drug Therapy, Combination
Female
Hemoglobin A, Glycosylated
Humans
Hypoglycemia
Hypoglycemic Agents
Male
Metformin
Middle Aged
Nitriles
Prospective Studies
Pyrrolidines
Treatment Outcome
Publisher: Informa Healthcare
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). 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/m2) (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. © 2015 All rights reserved: reproduction in whole or part not permitted.
URI: https://hdl.handle.net/11499/10532
https://doi.org/10.1185/03007995.2015.1019609
ISSN: 0300-7995
Appears in Collections:PubMed İndeksli Yayınlar Koleksiyonu / PubMed Indexed Publications Collection
Scopus İndeksli Yayınlar Koleksiyonu / Scopus Indexed Publications Collection
Tıp Fakültesi Koleksiyonu
WoS İndeksli Yayınlar Koleksiyonu / WoS Indexed Publications Collection

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