Author/Authors :
Mahar, Saeed Ahmed Liaquat National Hospital - Medical College, Pakistan , Hasan, Mohammad Imtiaz Diabetes Institute of Pakistan (DIP), Pakistan , Khan, Mohammad Imran Hasan Postgraduate Medical Institute/Lahore General Hospital - Diabetes Endocrine and Metabolic Centre, Pakistan , Fawwad, Asher Baqai Institute of Diabetes Endocrinology, Pakistan , Hussain, Shakir Aga Khan Hospital Kharadar, Pakistan , Maheshwary, Neeta Novartis Pharma Pakistan, Pakistan , Kumar, Kishore Novartis Pharma Pakistan, Pakistan , Siddiqi, Ahson Novartis Pharma Pakistan, Pakistan , Khan, Muhammad Athar King Saud Bin Abdulaziz University - Department of Medical Education, Saudi Arabia
Abstract :
Objective: To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan. Methods: VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with 1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured. Results: Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p 0.033). The reduction in HbA1c was 0.3% with vildagliptin from a baseline of 7.6% and 0.1% with SU from a baseline of 7.4% (between-treatment difference: -0.1% p 0.054). A reduction of 0.3 kg was seen with vildagliptin treatment vs. 0.2 kg weight gain in the SU group. Adverse events were experienced by 15.7% in the vildagliptin cohort and 17.4% in the SU group. Conclusion: The treatment with vildagliptin was associated with fewer hypoglycaemic events compared with SUs and was well tolerated with good glycaemic and weight control in patients with T2DM fasting during Ramadan.
Keywords :
DPP , 4 inhibitor , Fasting , Hypoglycaemia , Ramadan , Type 2 diabetes mellitus , Vildagliptin , Sulphonylurea.