Long Term Safety and Efficacy of Saroglitazar in Indian Patients with Diabetic Dyslipidemia and Very High Triglyceride Levels: Real World Evidence

Abstract

Objective: Diabetes and diabetic dyslipidemia with high triglycerides (TGs) are commonly associated. Saroglitazar is the first dual PPAR α/γ agonist approved in India for the management of diabetic dyslipidemia. The objective of this observational study was to assess the long-term safety and efficacy of saroglitazar in patients with diabetic dyslipidemia with very high triglycerides (> 500 mg/dL). Materials and methods: This was a single-center, retrospective observational study which was conducted among 150 patients with type 2 diabetes who had diabetic dyslipidemia with hypertriglyceridemia (> 500 mg/dL at baseline). All patients were on saroglitazar 4 mg once daily and all had complete follow-up data. At baseline, all patients were on stable doses of antidiabetic and statin therapy. Results: Significant reduction of TG and LDL-cholesterol was observed from baseline to 12th week: from 669.93 ± 81.22 to 268.72 ± 82.32 mg/dL and from 167.68 ± 10.881 to 118.88 ± 12.16 mg/dL (p < 0.0001 and < 0.001), respectively. The mean HbA1c was reduced from 8.02 ± 0.3 to 7.71 ± 0.5% (< 0.001). This reduction in lipid and glycemic parameters continued till 52th week. At 52 weeks mean TG, LDL-cholesterol and HbA1c were reduced to 221.51 ± 61.81 mg/dL, 118.88 ± 12.16 mg/dL and 7.12 ± 0.2 % (p <0.001 for all). No major adverse event was reported during the study period. Creatine phosphokinase (CPK), liver enzymes and creatinine did not alter significantly. Conclusions: Long term use of saroglitazar leads to significant improvement in both glycemic and lipid parameters in patients with diabetic dyslipidemia with very high triglycerides (>500 mg/dl) and initially not controlled by statins alone. Therefore, to fulfil the unmet need, long-term use of saroglitazar could be an effective, well tolerated and safe option.