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

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 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.