Background and Aims: Dyslipidemia is a strong predictor for cardiovascular diseases and its prevalence is rising rapidly worldwide. Saroglitazar (Lipaglyn®; Zydus Cadila, Ahmedabad, India), a novel dual peroxisome proliferator activated receptor agonist, is approved in India for management of diabetic dyslipidemia and hypertriglyceridemia in type 2 diabetes mellitus not controlled by statin alone. To evaluate the effect of saroglitazar in dyslipidemia, this 24-week clinical trial was conducted from December-2014 to October-2017 in India.

Methods: This was a multicentre, randomized, double-blind study conducted to evaluate the safety and efficacy of saroglitazar 2 mg and 4 mg compared to fenofibrate 160 mg in adult patients with hypertriglyceridemia (≥200 mg/dL). Total 997 subjects at 35 centres were randomized in a ratio of 2:2:1 to saroglitazar 2 mg, 4 mg, and fenofibrate 160 mg, respectively. Efficacy evaluation of triglyceride (TG) (primary outcome) and other lipid parameters was conducted at week-12 and week-24 from baseline.

Results: Saroglitazar 2 mg and 4 mg significantly reduced TG at week-12 and week-24 from baseline (Table-1). Saroglitazar 2 mg and 4 mg significantly reduced total cholesterol, very low-density lipoprotein, non high-density lipoprotein (HDL), apolipoprotein B and significantly increased HDL at week-12 and week-24 from baseline (Table-1). Results for the per-protocol and modified intention-to-treat populations were similar. No serious adverse events or deaths reported in the study groups. 

Conclusions: Saroglitazar was found to be efficacious and safe in patients with dyslipidemia.

02 - A CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAROGLITAZAR COMPARED TO FENOFIBRATE IN PATIENTS WITH DYSLIPIDEMIA