Results of a multicenter international study on the efficacy and safety of Remaxol in patients with drug-induced liver injury during antitumor therapy

Drug-induced liver injury (DILI) poses a significant challenge in patients with oncological diseases, as many antitumor agents exhibit hepatotoxicity, complicating treatment and worsening prognosis. Timely diagnosis and management of DILI are critical during antitumor therapy. Remaxol, a balanced infusion solution containing inosine, meglumine, methionine, nicotinamide, and succinic acid, has hepatoprotective properties. Objective. To evaluate the efficacy and safety of Remaxol in adult patients with DILI during antitumor therapy. Material and methods. This multicenter, international, prospective, non-interventional, parallel study included data from 334 patients. In real-world clinical practice, the efficacy and safety of Remaxol infusion solution (400 ml/day for 12 days) and S-adenosyl-L-methionine (Ademetionine) for parenteral administration (800 mg/day for 14 days) were assessed. The primary efficacy endpoint was the proportion of patients who completed polychemotherapy (PCT) in full without dose reduction of chemotherapeutic agents after treatment with Remaxol or Ademetionine. Safety evaluation included analysis of adverse reactions observed during treatment. Results. Comparison of patient groups receiving Remaxol or Ademetionine showed no significant difference in the key endpoint—the proportion of patients completing PCT without dose reduction (90.4% vs. 88.9%; p≥0.05). No statistically significant differences were found in the relative number of patients achieving full normalization of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, and total and direct bilirubin levels at visits 2, 3, and 4 (p≥0.05). Similarly, no significant changes in the dynamics of these indicators were detected during the study, in the condition based on the Karnofsky and ECOG scales (p≥0.05). Remaxol therapy was recognized as non-inferior in efficacy to Ademetionine therapy. No serious adverse reactions related to the study drugs were reported. Conclusion. The study results demonstrate the efficacy and safety of Remaxol in adult patients with drug-induced liver injury during antitumor therapy.