Comparison of the Efficacy, Tolerability and Side Effect Profile of Vildagliptin-Metformin with Metformin-GlibenclamideMamong Nigerian.

BACKGROUND:The use of fixed dose combination oral antidiabetic drugs (OADs) in the therapeutic management of type 2 diabetes mellitus (DM) patients is becoming popular among clinicians. Reduced pill burden with fixed combination OADs is generally perceived to improve adherence and efficacy. The aim of this study was to compare the efficacy, tolerability and side effects (SEs) profile of vildagliptin-metformin (VM) combination with metformin-glibenclamide (MG) combination in type 2 DM patients at the Aminu Kano Teaching Hospital (AKTH). METHODS:A descriptive prospective open-labeled comparative out-patient study of type 2 DM patients spanning over three months with 60 Patients assigned to two treatment groups - VM (Group 1) and MG (Group 2) of 30 patients each. Parameters measured at baseline, 6 weeks and 12 weeks of study included demographic and anthropometric data; fasting plasma glucose (FPG) level; 2-hour post-prandial (2-hrPPG) glucose; liver function tests (LFTs); Electrolyte, Urea and Creatinine (EUCr); and fasting plasma lipids. Glycated haemoglobin (HbA1c) was measured at baseline and at 12 weeks of the study. A p-value of <0.05 was considered to be significant. RESULTS:There was improvement in FPG, 2hr PPG, HbA1c in all subjects in both groups at the end of the study (6.44±0.79mmol/ l, 8.80±1.16mmol/l and 7.22±1.20% respectively in group 1(VM); and 6.40±0.83mmol/l, 9.29±1.39 and 7.25±0.96% respectively for group 2(MG). There was a significant improvement in body mass index (BMI) of subjects in group 1 (30.02±4.16 at baseline, 29.71±4.12 at study end) compared to those in group 2 (31.98±6.32 at baseline, 32.62±6.30 at study end), p=0.04. At the end of the study, the efficacy of VM (HbA1C-7.22±1.20%) was comparable to that of MG (HbA1c-7.25±0.96), P=0.92. The tolerability of MG (attrition rate 6.7%) was better than that of VM (attrition rate 13%), although this difference was not statistically significant P=0.16. The subjects on VM experienced more gastrointestinal (GIT) side effects compared to those on MG. The major SEs experienced by those on MG were hypoglycaemia and weight gain. VM was less tolerated and had more GIT side effects than MG. CONCLUSION:The use of single pill combination oral antidiabetic medications is associated with improved efficacy.