Impact of Saroglitazar as an Add-on Therapy to Rosuvastatin in Patients with Diabetic Dyslipidemia– A Prospective, Single Centre, Observational Study in Indian Patients

Abstract

Background: Diabetic dyslipidemia in type 2 diabetes mellitus is defined by elevated TG levels and decreased HDL-C levels, as well as elevated or normal LDL-C levels. In diabetic dyslipidemia, the addition of saroglitazar to statins may provide comprehensive control of lipid parameters as well as good glycemic control, particularly in patients with high TG levels that are not controlled by statins alone. Objective: To evaluate the effectiveness and safety profile of saroglitazar as an add-on therapy in patients with diabetic dyslipidemia already receiving rosuvastatin therapy. Methods: In this open-label, prospective, single-center, observational study, newly diagnosed DM patients were randomly assigned to one of two groups, Rosuvastatin only (R) or Rosuvastatin plus Saroglitazar (RS). Both groups received rosuvastatin for 12 weeks, after which group R received the same treatment for another 12 weeks, and group RS received saroglitazar 4mg in addition to rosuvastatin for another 12 weeks. At the end of 24 weeks, the primary outcome measured were changes in baseline lipid parameters total cholesterol, serum TG, LDL, VLDL, HDL, and glycemic parameter HbA1c between and within Group R and Group RS. Secondary outcomes included changes in metabolic parameters such as blood urea, serum creatinine, SGOT, SGPT, and CPK, as well as reported adverse events. These assessments were made for both Group R and Group RS at both the 12-week and 24-week. Result: When compared to Group R, patients in Group RS improved significantly in lipid parameters such as total cholesterol, serum TG, LDL, VLDL, HDL, and glycemic parameter HbA1c at the end of 24 weeks. Secondary outcomes revealed that Group RS had no significant side effects when compared to Group R, as evidenced by low fluctuations in renal and hepatic markers such as B. urea, S. Creatinine, SGOT, SGPT, and CPK levels over 24 weeks. As a result, the safety profiles of the combination treatment and rosuvastatin alone were comparable. Conclusion: Saroglitazar, when combined with rosuvastatin, was found to improve lipid and glycemic parameters in diabetic dyslipidemia patients who were already on rosuvastatin.