Journal of AdvancedMedical and Dental Sciences Research

Background: Diabetic dyslipidemia (DD) is an important factor contributing to the increased risk of CVDs.The objective of this study was to evaluate the long-term safety and efficacy of Saroglitazar on diabetic dyslipidemia with very high triglyceride (>500 mg/dl) in real world clinical practice. Materials & Methods: 150 patients with type 2 diabetes on antidiabetic medications and statins, age above 18 years and triglycerides 500 mg/dL were included. Patients were treated with Saroglitazar 4 mg once daily and the follow-up data were available for 12 months after Saroglitazar treatment. Serum fasting plasma glucose, Serum post prandial glucose, Glycated hemoglobin (HbA1c), Blood urea, Serum creatinine, S.G.O.T, S.G.P.T, Total lipids, Phospholipids, Triglycerides, Total Cholesterol, HDL Cholesterol, LDL Cholesterol, VLDL Cholesterol was assessed. Results: There was significant reduction of TG and LDLcholesterol was observed from baseline to 12th weeks 669.93±81.22 to 268.72±82.32 mg/dl and from 167.68±10. to 118.88±12 mg/dl (p< 0.01). The mean HbA1c was reduced from 8.02±0.3 to 7.71±0.5% (p< 0.01). This reduction in lipid and glycemic parameters were continued till 52 weeks. At 52 weeks mean TG, LDL-cholesterol and HbA1c was reduced to 221.51±61.81 mg/dl, 118.88±12.16 mg/dl and 7.12±0.2 % (p< 0.01). No major adverse event reported during the study period. CPK, liver enzymes and creatinine did not alter significantly. Conclusion: The addition of Saroglitazar in patients on existing baseline antidiabetic medications showed a significant 0.9% absolute reduction in HbA1c and significant improvement in fasting and post prandial plasma glucose. There were no serious adverse events or alteration in liver enzymes or serum creatinine and edema or weight gain reported in this study. Saroglitazar is a very effective therapeutic option in diabetic dyslipidemia with very high triglycerides level, not controlled by statins. It is very safe for long term use.