Effectiveness and Tolerability of Vildagliptin in Indian Patients with Type 2 Diabetes Mellitus: Results From Edge−A Real-World Observational Study.

ABSTRACT

Objective: To assess the effectiveness and tolerability of vildagliptin in combination with another oral antidiabetic drug (OAD) versus any other two-agent OAD combinations in Indian patients with type 2 diabetes mellitus (T2DM) in a real-world setting. Study design: This was a post hoc analysis of a multicenter, prospective, 1-year, observational EDGE study for patients enrolled in India. The primary efficacy endpoint of the study was proportion of patients achieving glycosylated hemoglobin (HbA1C) reduction of >0.3% without peripheral edema, hypoglycemic event, discontinuation due to a gastrointestinal event or weight gain. One of the secondary efficacy endpoints was proportion of patients achieving HbA1C <7% without hypoglycemia and weight gain. Results: The mean age, body mass index, HbA1C and duration of T2DM were 51.8 years, 26.6 kg/m2, 8.6% and 4.3 years, respectively. The proportion of patients achieving the efficacy endpoints was significantly higher in the vildagliptin cohort compared with the comparator cohort (p < 0.0001). The vildagliptin cohort showed a numerically greater reduction in HbA1C than the comparator cohort (1.4 vs 1.1%; analysis not pre-specified). Adverse events were comparable in both groups (4.2% vs 4.9%). Conclusion: In India, in a real-world setting, vildagliptin showed better overall clinical benefits compared with comparator OADs in patients with T2DM.