Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - Galata study
Dökmetaş, Hatice Sebile
Baloğlu Ar, İdilhan
MetadataShow full item record
CitationAyvaz, 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/10.1185/03007995.2015.1019609
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.