An Observational Study of Reduction in Glycemic Parameters and Liver Stiffness by Saroglitazar 4 mg in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease.

Asis Mitra

doi:10.7759/cureus.9065

Abstract

BackgroundMetabolic 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. MethodIn 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.ResultsAt 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.ConclusionIn 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.

Highlights

At the six-month follow-up after saroglitazar treatment, significant improvement was observed in glycemic parameters, liver stiffness on FibroScan, and serum transaminase levels
Dyslipidemia and type 2 diabetes mellitus (T2DM) are the most commonly associated comorbid conditions seen in patients with metabolic disorders and cardiovascular diseases (CVD)
In 2015, a study analyzed the results of two trials, the Study of RO4607381 in Stable Coronary Heart Disease Patients With Recent Acute Coronary Syndrome and Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL), which showed that high TG levels (> 175 mg/dL on the long-term and > 195 mg/dL on short-term, respectively) in spite of statin therapy in post-acute coronary syndrome (ACS) patients led to an increased CVD risk (60% and 50% higher on long- and shortterm, respectively) compared to those patients who had lower TG levels (≤ 80 mg/dL on long-term and ≤ 135 mg/dL on short-term) [12]

Summary

Introduction

Dyslipidemia and type 2 diabetes mellitus (T2DM) are the most commonly associated comorbid conditions seen in patients with metabolic disorders and cardiovascular diseases (CVD). Diabetes is associated with multiple comorbidities, such as chronic hyperglycemia, dyslipidemia, and hypertension It is associated with a non-cardiovascular disease like nonalcoholic fatty liver disease (NAFLD). There is no Food and Drug Administration (FDA) approved drug available for the treatment of NAFLD. Metabolic abnormal conditions, such as diabetes and high triglycerides (TGs), are commonly associated with nonalcoholic fatty liver disease (NAFLD). 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

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