Saroglitazar, being a dual
PPAR-α/γ agonist, has shown beneficial effect in diabetic
dyslipidemia and
hypertriglyceridemia.
Fibrates are commonly used to treat severe
hypertriglyceridemia. However, the effect of
saroglitazar in patients with moderate to severe
hypertriglyceridemia was not evaluated. We conducted a study to compare the efficacy and safety of
saroglitazar (4 mg) with
fenofibrate (160 mg) in patients with moderate to severe
hypertriglyceridemia. This was a multicenter, randomized, double-blinded, double-dummy, active-control, and noninferiority trial in adult patients with fasting
triglyceride (TG) levels of 500-1,500 mg/dl. The patients were randomized in a 1:1 ratio to receive daily dose of
saroglitazar or
fenofibrate for 12 weeks. The primary efficacy end point was the percent change in TG levels at week 12 relative to baseline. The study comprised of 41 patients in the
saroglitazar group and 41 patients in the
fenofibrate group. We found that the percent reduction from baseline in TG levels at week 12 was significantly higher in the
saroglitazar group (least square mean = -55.3%; SE = 4.9) compared with the
fenofibrate group (least square mean = -41.1%; SE = 4.9; P = 0.048). Overall, 37 treatment-emergent adverse events (AEs) were reported in 24 patients (
saroglitazar: 13;
fenofibrate: 11). No serious AEs were reported, and no patient discontinued the study because of AEs. We conclude that
saroglitazar (4 mg) is noninferior to
fenofibrate (160 mg) in reducing TG levels after 12 weeks of treatment, was safe, and well tolerated.