An Investigator Initiated Prospective, Single Arm Observational Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non- Alcoholic Steatohepatitis (NASH)
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Date
2019-12
Journal Title
Journal ISSN
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Publisher
International Society for Contemporary Medical Research
Abstract
Introduction: Saroglitazar is known to safely and effectivelyimprove dyslipidemia by reducing triglyceride (TG), lowdensity lipoprotein (LDL) cholesterol, very low-densitylipoprotein (VLDL) cholesterol, non-high-density lipoprotein(non-HDL) cholesterol and increasing high densitylipoprotein (HDL) cholesterol. In addition, saroglitazar canimprove glycemic indices in diabetic patients by reducingfasting plasma glucose (FPG) and glycosylated haemoglobin(HbA1c). Aim of the study was to evaluate the hospital basedclinic-pathological profile, diagnosis, treatment and followup of Indian patients with Non-alcoholic fatty liver diseaseand to evaluate the safety and efficacy of Saroglitazar 4 mg inpatients with Non-alcoholic fatty liver disease /Non-alcoholicSteatohepatitis in real life setting.Material and methods: This was an ongoing observationalstudy with the sample size of 52 patients having Nonalcoholic fatty liver disease and dyslipidaemia with or withoutType 2 Diabetes Mellitus and treatment follow up for a periodof 1 year in the Department Of Gastroenterology. The datawas collected from eligible patients who have been prescribedSaroglitazar 4 mg once daily in routine clinical practice.Primary endpoints were to see liver stiffness. Secondaryendpoints were to measure serum alanine aminotransferase,aspartate aminotransferase level and Serum triglycerideslevel.Results: There was a significant decrease in Serum alanineaminotransferase (p <0.001), aspartate aminotransferase (pvalue < 0.001), triglycerides (p value <0.001) and triglycerides(p value 0.01), levels after the treatment as compared to thebaseline.Conclusion: Saroglitazar treatment is effective and there isa significant difference in Serum alanine aminotransferaseand aspartate aminotransferase, triglycerides and LiverStiffness Measurement levels after treatment. The drug can besuccessfully administered for the treatment of Non-alcoholicfatty liver disease.
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Keywords
Non-alcoholic Fatty Liver Disease, Triglycerides, Dyslipidemia, Insulin, Alanine Aminotransaminase
Citation
Hajare Santosh D, Gokak Varadaraj P, Ghorpade Sandesha, Patil Amar, Jadhav Arvind. An Investigator Initiated Prospective, Single Arm Observational Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients with Non-Alcoholic Fatty Liver Disease (NAFLD)/Non- Alcoholic Steatohepatitis (NASH). International Journal of Contemporary Medical Research . 2019 Dec; 6(12): l5-l7