A Prospective, Multicentric Study to Evaluate the Effects of Saroglitazar on Non-HDL Cholesterol and Small Dense LDL Particles in Patients with Diabetic Dyslipidemia

Abstract

Saroglitazar, a dual PPAR α/γ agonist, is approved in India for the treatment of diabetic dyslipidemia (DD) not controlled with statins. DD is highly atherogenic as it is associated with high triglycerides (TG), high small dense LDL (sdLDL) and low HDL-C. In this, prospective multi-centric study conducted in patients with type 2 diabetes and triglycerides (TG) ≥200 mg/dL after lifestyle and stable statin therapy for at least 3 months, efficacy and safety of saroglitazar has been evaluated. Total 104 patients (78% male) with mean age of 59.1 ± 11.4 years were enrolled. All subjects were given saroglitazar 4mg once daily for 24 weeks. The effects of saroglitazar were evaluated at 24 weeks by using paired t-test. Six months follow-up data is available from 73 patients. At 24 weeks the primary end point showed a significant reduction in non-HDL-C (from 138 ± 51 mg/dL to 113 ± 44 mg/dL; p<0.001) and sdLDL (from 31.7 ± 11.8 mg/dL to 26.0 ± 11.9 mg/dL; p<0.001). Of the secondary end points the values of TG, HDL-C, total cholesterol and HbA1c were also significantly improved at 24 weeks (Table). No major adverse event reported during the study period. This is the first study evaluating the effect of saroglitazar on sdLDL in patients with DD. The results indicate that saroglitazar is safe and well tolerated and effectively reduces sdLDL particles along with non-HDL-C.Change in laboratory parameters at 24 weeks follow-up (All values are Mean±SD)Laboratory parametersBaseline24 weeks follow-upP-valueNon HDL-C (mg/dL)138±51113±44<0.001TG (mg/dL)351±360247±445<0.001LDL-C (mg/dL)90±3882±240.074sdLDL (mg/dL)31.7±11.826.0±11.9<0.001HDL-C (mg/dL)35.6±7.540.6±8.0<0.001Total cholesterol (mg/dL)172±52154±43<0.001HbA1c (%)7.98±1.666.95±0.71<0.001 Disclosure U. Kaul: None. P. Jain: None. R. Kachru: None. V. Bhatia: None. P. Arambam: None. S. Shekhawat: None. Y. Diana: None. K. Rawat: None. S. Singh: None. A. Jaiswal: Employee; Self; Zydus Cadila.