Background Metabolic abnormal conditions, such as diabetes and high
triglycerides (TGs), are commonly associated with
nonalcoholic fatty liver disease (
NAFLD). Currently, there is no approved
pharmacotherapy for
NAFLD.
Saroglitazar, the world's first approved dual
peroxisome proliferator-activated receptors (
PPAR) α and γ agonist, was approved in India for the treatment of diabetic
dyslipidemia. The objective of this study was to observe the safety and effectiveness of
saroglitazar, 4 mg once daily, in reducing glycemic parameters and
liver fibrosis in
type 2 diabetes mellitus (T2DM) patients with
NAFLD. Method In this prospective observational study, we enrolled 30 patients with T2DM and
NAFLD (primarily detected by ultrasonography (USG) of the abdomen) who were treated with
saroglitazar, 4 mg once daily, and the follow-up data were available for six months after
saroglitazar treatment. During follow up, all patients were on stable
antidiabetic and
statin therapy. Liver stiffness was measured by FibroScan® (Echosens™ North America, Waltham, MA) elastography at baseline and at the six-month follow-up. Results At the six-month follow-up after
saroglitazar treatment, significant improvement was observed in glycemic parameters, liver stiffness on FibroScan, and serum
transaminase levels. The serum TG levels were significantly reduced with
saroglitazar. No major adverse event was reported. Conclusion In this observational study of patients with T2DM and
NAFLD,
saroglitazar improved liver stiffness, as well as the glycemic and
lipid parameters. A long-term randomized controlled clinical trial is required to further establish the safety and efficacy of
saroglitazar in the treatment of T2DM and
NAFLD.