Effectiveness and Safety of Saroglitazar in Patients With Metabolic Disease in India Stratified by Estimated Glomerular Filtration Rate (eGFR): A Retrospective, Observational, Electronic Medical Record (EMR)-Based Real-World Evidence Study

Purpose Metabolic dysfunction and chronic kidney disease (CKD) often coexist, presenting therapeutic challenges. Saroglitazar, a dual proliferator-activated receptor (PPAR)-α/γ agonist, shows promising effects in managing dyslipidemia and glycemic abnormalities; however, real-world evidence (RWE) is limited across varying degrees of renal function. This study evaluated the effectiveness and safety of saroglitazar (4 mg) in patients with metabolic disease in India stratified by estimated glomerular filtration rate (eGFR). Methods This retrospective observational study analyzed the electronic medical records (EMRs) of 614 patients with metabolic disorders prescribed saroglitazar. Changes in lipid and glycemic parameters, liver enzymes, and renal function were assessed from baseline to follow-up (minimum 90 days) across eGFR categories. Results A total of 614 patients were included. Metabolic and cardiac disorders were the most common conditions at baseline. Significant reductions were observed in triglycerides (TG, -62.68 mg/dL), low-density lipoproteins (LDL, -7.03 mg/dL), and glycosylated hemoglobin (HbA1c, -0.76%) in the overall population (p < 0.001), with similar reductions in patients with eGFR ≥90 mL/min/1.73 m² and 60-89.99 mL/min/1.73 m². Patients with hepatic conditions showed a significant decrease in aspartate transaminase (AST) and alanine transaminase (ALT) levels. eGFR levels remained stable across categories. Saroglitazar was associated with a low incidence of adverse events, including asthenia (n = 12, 1.95%) and pyrexia (n = 6, 0.97%). Conclusion Saroglitazar was associated with improved lipid and glycemic profiles across various levels of kidney function, with limited safety concerns. These real-world findings suggest the potential metabolic benefits of saroglitazar in Indian patients with metabolic abnormalities, across diverse renal functions.