A Prospective, Multicentre, Single Arm Clinical Study to Evaluate the Effect of Saroglitazar on Non High-Density Lipoprotein Cholesterol in Patients with Diabetic Dyslipidemia Inadequately Controlled with Diet, Exercise, and Statin-The GLIDDER Study

Objective: Diabetic dyslipidemia is highly atherogenic as it is associated with high triglyceride (TG), high small dense low-density lipoprotein (sd-LDL) particles and low high-density lipoprotein cholesterol (HDL-C). Saroglitazar, a dual peroxisome proliferator activated receptor agonist (predominant PPAR-alpha agonist and modest PPAR-y agonist), is approved in India for the management of diabetic dyslipidemia. The GLIDDER study was done to evaluate the effects of Saroglitazar 4 mg on non HDL-C as the primary endpoint and sd-LDL particles as a secondary endpoint in diabetic patients with dyslipidemia. Methods: This study was a 24 weeks, prospective, multicentre, single arm study conducted in 104 patients with diabetic dyslipidemia (TG >= 200 mg/dL) inadequately controlled with diet, exercise, and statins. It was conducted from April 2015 to November 2017 at three Indian centres. All the selected patients were given Saroglitazar 4 mg once daily before breakfast for 24 weeks. Efficacy evaluations of non HDL-C (calculated as total cholesterol (TC) minus HDL-C) (primary endpoint) and other lipid parameters (sd-LDL particles, TC, TG, HDL-C) and glycemic parameters (glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG)) were conducted after 24 weeks and compared to the baseline levels. Results: Total 104 patients (22% female) with mean age of 59.1 +/- 11.4 years were enrolled in this study. In the per-protocol population, there was a significant reduction in non HDL-C (from 142.3 +/- 59.3 mg/dL (baseline) to 109.9 +/- 45.5 mg/dL (week-24); p<0.0001) and sd-LDL (from 32.5 +/- 11.3 mg/dL (baseline) to 25.9 +/- 11.8 mg/dL (week-24); p<0.0001). There was a significant reduction in TG, TC, HbA1c, and FPG with a significant increase in HDL-C at week-24 from baseline levels (p<0.05). Conclusion: Saroglitazar effectively reduces non HDL-C and sd-LDL particles in patients with diabetic dyslipidemia.