Spectrum, Clinico-pathological Profile of Non-Alcoholic Fatty Liver Disease and its Treatment Response with 48week Therapy of Saroglitazar

Abstract

Objective: Nonalcoholic fatty liver disease (NAFLD) is considered the most common cause of chronic liver disease in both the developed as well as developing countries. The entity includes patients with simple steatosis and those with non-alcoholic steatohepatitis (NASH). NASH is an advanced stage of NAFLD, and has a higher risk of progressing to liver cirrhosis or hepatocellular carcinoma (HCC). Saroglitazar a dual PPAR   agonist was approved by Drug controller of India (DGCI) for use in NAFLD.

METHODOLOGY: This study was conducted in Department of Gastroenterology in a tertiary care centre in Northern India. All patients with NAFLD meeting the inclusion/exclusion criteria were evaluated so as to categorize them into NAFL, NASH, and NASH related cirrhosis and HCC. All patients were put on Saroglitazar 4 mg, among them, 25 patients have undergone paired biopsy after 48 weeks of treatment.  End points of efficacy of Saroglitazar were assessed after 48 weeks in terms of serum ALT, Fibro- scan and biopsy parameters.

RESULTS: A total of 90 NAFLD patients were enrolled in this study of which 48 were males and 42 females with a mean age of 44 ± 12, range (20-72 years).  Comorbid illness was present in majority 40(%) (Dyslipidaemia =22 (%), DM =14 (%), HTN =4(%)). Majority of patients (68/90, %) were overweight or obese. Mean ALT and Mean fibro- scan values were 89 ± 73 and 11.6 ± 8.7 respectively. All patients underwent liver biopsy and based on NAFLD Activity score and fibrosis score, Patients were divided into NAFL (31/90, 34%), NASH (43/90,47%) and Cirrhosis (16/90,17%). On assessing the various non-invasive parameters, it was concluded that those patients who have advanced Fibrosis on histology have higher Mean in terms of Age, Waist/ Hip, LSM, BARD 4 Score, and FIB4 Values, while have lower Mean values of AST, ALT, HB, PLT, NAFLD Score and NAS score. Those 24 patients who underwent paired biopsy after 48 weeks of treatment showed significant change in mean ALT (92 vs 62), NAFLD activity score (5.62 vs 3.62) and fibrosis (2.71 vs 2.13). 

CONCLUSION: NAFLD is global epidemic. Majority of patients have metabolic syndrome and NAFLD is a component of it. Patients who have diabetes (diabetic NAFLD) have advanced disease as they have high fibro-scan valves, grade 4 fibrosis on liver biopsy. Saroglitazar has major impact in reversal of various parameters including fibrosis.