Ayvaz, GöksunKeskin, LezzanAkın, FulyaDökmetaş, Hatice SebileTaşan, Ertu?rulBaloğlu Ar, İdilhanUren, Emel10.07.20192019-07-1010.07.20192019-07-102015Ayvaz, G., Keskin, L., Akın, F., Dökmetaş, H. S., Taşan, E., Baloğlu Ar, İ. ... Uren, E. (2015). Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study. Current Medical Research and Opinion, 31(4), 623-632. https://dx.doi.org/10.1185/03007995.2015.10196090300-79951473-4877https://dx.doi.org/10.1185/03007995.2015.1019609https://hdl.handle.net/20.500.12511/2268WOS: 000351925900004PubMed ID: 25697921Objective: 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.eninfo:eu-repo/semantics/openAccessDPP-4HbA1cReal-lifeType 2 Diabetes VildagliptinArticle31462363210.1185/03007995.2015.1019609Q2Q1