Saroglitazar is non-inferior to fenofibrate in reducing triglyceride levels in hypertriglyceridemic patients in a randomized clinical trial.

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, 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, non-inferiority trial in adult patients with fasting triglyceride levels of 500 to 1500 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 endpoint was the percent change in triglyceride (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 (LS Mean - 55.3%, SE = 4.9) compared with the fenofibrate group (LS Mean = -41.1%, SE = 4.9, p=0.048). Overall, 37 treatment-emergent adverse events (TEAEs) were reported in 24 patients (Saroglitazar: 13, Fenofibrate: 11). No serious AEs were reported and no patient discontinued the study due to AEs. We conclude that saroglitazar (4 mg) is non-inferior to fenofibrate (160 mg) in reducing TG levels after 12 weeks of treatment, was safe and well-tolerated.