Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey - GALATA study
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2015
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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.
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Keywords
Adamantane , Body Mass Index , Cohort Studies , Diabetes Mellitus, Type 2 , 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 , Turkey , hemoglobin A1c , liver enzyme , metformin , vildagliptin , adamantane , antidiabetic agent , dipeptidyl peptidase IV inhibitor , glycosylated hemoglobin , metformin , nitrile , pyrrolidine derivative , vildagliptin , 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 , hypoglycemia , prospective study , treatment outcome , Turkey