Comparison of Effectiveness and Safety of Add-on Therapy of Saroglitazar and Fenofibrate with Metformin in Indian Patients with Diabetic Dyslipidaemia.

Abstract

Diabetic dyslipidaemia poses a therapeutic challenge. New therapies have emerged in this patient subgroup to enhance outcome and improve compliance. The aim of this study was to compare the effectiveness and safety of add on therapy of saroglitazar and fenofibrate with metformin in Indian patients with diabetic dyslipidaemia. Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) and fenofibrate (160 mg/day) while group B patients received metformin (1000 mg/day) and saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and week 12 visits. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and on week 4, 8 and 12 visits. TG and HbA1C levels decreased significantly at week 12 from their respective baseline values (p< 0.05) in both groups. FPG and PPPG levels significantly decreased at weeks 4, 8 and 12 compared to their pretreatment values (p< 0.05) in both groups. TG and HbA1C levels in group B decreased significantly compared to group A at week 12. FPG and PPPG levels in group B also decreased significantly compared to group A at every interval. Inter group analysis did not show any statistically significant change in body weight, LDL-C and HDL-C at week 12. Add on therapy of saroglitazar with metformin significantly decreased TG, HbA1C, FPG and PPPG levels compared to add on therapy of fenofibrate with metformin in Indian patients with diabetic dyslipidaemia.