​​​​​​​Effectiveness, Safety and Tolerability of Vildagliptin and Vildagliptin+Metformin in Real-world Setting in the Philippines—Results from the GUARD Study

Introduction: GUARD (vildaGliptin clinical Use in reAl woRlD) was a multinational, prospective, observational study that assessed the effectiveness, safety and tolerability of vildagliptin and vildagliptin+metformin in patients with type 2 diabetes mellitus (T2DM) under real-world conditions across four geographical regions (Asia, the Middle East, Central America and Africa). The current paper discusses the results of patients with T2DM enrolled in the Philippines. Methods: Patients with T2DM who were prescribed vildagliptin or vildagliptin+metformin combination therapy were enrolled and followed as per routine clinical practice for 24 ± six weeks. Primary endpoint was the change in HbA1c from baseline to study end (week 24±6). Key secondary endpoints included proportion of patients reaching target HbA1c ≤7.0%, incidence of hypoglycemic events, adverse events (AEs) and serious AEs (SAEs). Results: A total of 1,117 patients were included in the final analysis, 280 on vildagliptin (of these, eight patients received additional oral antidiabetes medications) and 837 on vildagliptin+metformin. At baseline, the mean (±SD) age of the enrolled population was 54.1±11.5 years, BMI 26.3±4.7 kg/m2, HbA1c 8.0±1.2% and T2DM duration 2.3±4.0 years. At study end, significant mean (±SE) reductions in HbA1c of -1.2±0.1% (p<0.0001) and -1.5±0.1% (p<0.0001) from a baseline of 7.6±1.1% and 8.1±1.2% were observed for the vildagliptin and vildagliptin+metformin group, respectively. A similar proportion of patients achieved HbA1c ≤7.0% in the vildagliptin (66.1%) and vildagliptin+metformin group (62.7%). Changes in body weight and BMI from baseline to week 24±6 were statistically significant (p<0.0001) in both the vildagliptin (-1.5±0.3 kg; -0.6±0.1 kg/m2) and the vildagliptin+metformin group (-1.4±0.2 kg; -0.5±0.1 kg/ m2). The incidence of hypoglycemia was low—six patients reported hypoglycemia in the vildagliptin+metformin group and none in the vildagliptin group. Incidence of adverse events was also low in both the groups (vildagliptin, 8.6% and vildagliptin+metformin, 5.3%). Conclusion: Vildagliptin and vildagliptin+metformin significantly reduced HbA1c with good weight control and low incidence of hypoglycemia in patients with T2DM under real-world conditions in Philippines. Key words: real-world, vildagliptin, type 2 diabetes mellitus, Philippines