Effect of ursodeoxycholic acid on liver function and lipid, carbohydrate, and purine metabolism in the combination treatment of patients with metabolic dysfunction-associated steatotic liver disease: a prospective, randomized, open-label, parallel-group comparative study

Abstract

Objective — to improve treatment efficacy in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) by evaluating the effect of ursodeoxycholic acid (UDCA) as part of combination treatment on liver function parameters and lipid, carbohydrate, and purine metabolism. Materials and methods. This prospective, randomized, open-label, parallel-group comparative study enrolled 59 patients with MASLD aged over 18 years. The study group comprised 39 patients who received UDCA (Ursis, manufactured by Kyiv Vitamin Plant JSC) in addition to standard MASLD treatment, while the control group consisted of 20 patients with MASLD who received standard treatment alone. All patients underwent comprehensive laboratory testing to assess liver function parameters and lipid, carbohydrate, and purine metabolism and their changes after 12 weeks. Statistical analysis was performed using R software v. 4.4.1 and EZR v. 1.68. Results. Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyl transpeptidase, and total bilirubin levels were statistically significantly lower in the group of MASLD patients receiving UDCA for 12 weeks in addition to standard treatment compared with the control group. A positive effect of UDCA on carbohydrate metabolism was established, manifested as reductions in fasting blood glucose, glycated hemoglobin, and HOMA-IR, as well as on the lipid profile, through reductions in total cholesterol, low-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and the atherogenic coefficient. Also, the study group showed a statistically significantly lower uric acid level after treatment compared with the group of patients who did not receive UDCA. Conclusions. The use of UDCA as part of combination treatment for MASLD has a beneficial effect on liver function parameters and on lipid, carbohydrate, and purine metabolism and is an important component in achieving better control of cardiometabolic risk factors. This supports the feasibility of considering its use in the management of this patient category alongside lifestyle modifications and other pharmacological approaches.