NDLI: Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Ayvaz, Goksun Keskin, Lezzan Akin, Fulya Dokmetas, Hatice Sebile Tasan, Ertugrul Ar, Idilhan Baloglu Uren, Emel
Spatial Coverage	Turkey
Description	Country affiliation: Turkey Author Affiliation: Ayvaz G ( Gazi University School of Medicine , Ankara , Turkey.)
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/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.
File Format	HTM / HTML
ISSN	03007995
Issue Number	4
Volume Number	31
e-ISSN	14734877
Journal	Current Medical Research and Opinion
Language	English
Publisher	Taylor & Francis
Publisher Date	2015-04-01
Publisher Place	Great Britain (UK)
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Medicine Adamantane Analogs & Derivatives Hypoglycemia Metformin Nitriles Pyrrolidines Administration & Dosage Adverse Effects Body Mass Index Cohort Studies Diabetes Mellitus, Type 2 Diagnosis Drug Therapy Dipeptidyl-peptidase Iv Inhibitors Drug Monitoring Drug Therapy, Combination Female Hemoglobin A, Glycosylated Analysis Humans Chemically Induced Prevention & Control Hypoglycemic Agents Therapeutic Use Male Middle Aged Prospective Studies Treatment Outcome Turkey Journal Article Multicenter Study Observational Study Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Medicine

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