Evaluation of Pharmacotherapies for Alcoholic Liver Disease: A Retrospective Real-World Evidence Study

Abstract

Background: Ursodeoxycholic acid (UDCA), a hepatoprotective agent demonstrates several beneficial effects on liver biochemistry measures and thus, it might be useful for the management of Alcoholic liver disease (ALD). Objective: To evaluate the pharmacotherapies for ALD using retrospective real-world evidence. Methods: In this retrospective study, the Electronic Medical Records (EMRs) of patients with ALD who were prescribed various pharmacotherapies between January 2021 and April 2021 at two Indian healthcare settings were reviewed. The effectiveness outcomes were assessed in terms of mean difference and proportion of patients showing improvement in the levels of liver enzymes (Aspartate aminotransferase [AST], Alanine aminotransferase [ALT] and γ-glutamyl transferase [GGT]) and conjugated bilirubin from baseline to 30-days follow-up. Results: A total of 298 patients were included and divided into two study groups - scientific and herbal groups. The scientific group included patients prescribed with drugs like UDCA, pentoxifylline, ademetionine, metadoxine, and nutritional supplementation. The herbal group included patients prescribed with four different Herbal Preparations. Of 193 patients in the scientific group, a majority (76.7%; n=148/193) of the patients received UDCA; of these, 107 patients' data were available at the 30-days follow-up. In the herbal group (n=105), a majority (62.9%; n=66/105) of the patients received Herbal Preparation 1, and 78 patients had data at follow-up. The elevated levels of liver enzymes (AST, ALT, GGT) at baseline were significantly reduced (p<0.05) at follow-up in patients prescribed with UDCA vs. Herbal Preparation 1. The change from baseline to 30 days in conjugated bilirubin was significantly higher in the UDCA vs. Herbal Preparation 1 (-45.2% vs. -33.5%, p<0.001). There was considerable improvement in the proportion of patients with elevated AST and ALT in the UDCA group. No serious adverse events were reported in either of the groups. Conclusion: The present study demonstrates that UDCA and Herbal Preparation 1 are majorly used in the management of ALD. UDCA has shown a substantial hepatoprotective effect as evident by significant improvements in the liver biochemistry of ALD patients as compared to the Herbal Preparation 1. Overall, the data from the current study suggests the use of UDCA as an initial therapy for ALD patients with altered liver enzymes.