Publication:

A randomized comparative study of efficacy and safety of saroglitazar with fenofibrate in diabetic dyslipidemic patients on metformin and glimeperide

Background This study was conducted to compare the efficacy and safety of saroglitazar with fenofibrate in Indian diabetic dyslipidemic patients who were on Metformin and Glimepiride.

Methods Adults patients with diabetic dyslipidaemia fulfilling the inclusion criteria were randomized in two groups. Group A patients received metformin (1000 mg/ day) + Glimepiride (4 mg/day) with fenofibrate (160 mg/day), while group B patients received metformin (1000 mg/day) + Glimepiride (4 mg/day) with saroglitazar (4 mg/day). Glycosylated haemoglobin (HbA1C), triglyceride (TG), LDL- cholesterol (LDL-C), HDL-cholesterol (HDL-C) levels were measured at baseline and at 12 weeks. Fasting plasma glucose (FPG) and post prandial plasma glucose (PPPG) were measured at baseline and at 4, 8 and 12 weeks.

Results There was a significant reduction in TG and HbA1C levels at 12 weeks from the baseline value (p=0.001) in both groups. However, there was no significant reduction in TG between the groups at 12 weeks but HbA1C levels in group B decreased significantly compared to group A at 12 weeks. Also, there was a significant reduction in FPG and PPPG levels at 4, 8 and 12 weeks in both groups from their baseline values (p=0.001). The reduction in FPG and PPPG levels in group B was statistically significantly compared to group A at every interval. There was statistically significant change in LDL-C and HDL-C at 12 weeks from baseline in both the groups. Also, there was significant rise in HDL-C in group B when compared to group A.

Conclusions Group B patients on saroglitazar with metformin and Glimepiride showed a significant reduction in HbA1C, FPG and PPG levels compared to group A patients on fenofibrate with metformin and Glimepiride.