Effectiveness of ademetionine in patients with intrahepatic cholestasis syndrome in the drug induced liver damage

Abstract

Objective — to investigate the effectiveness and safety of the generic ademetionine drug, Hepamethion lyophilizate for solution for injection (by the «Arterium» corporation) in comparison with the original drug ademetionine in patients with intrahepatic cholestasis syndrome against the background of drug induced liver damage (DILI) at the treatment of COVID­­ 19. Materials and methods. The examination involved 60 patients with DILI. Patients of the main group (13 men and 17 women, the mean age 54.6±18.2 and 48.7±19.2 for men and women, respectively) were administered the generic ademetionine drug Hepamethion 1000 mg a day intravenously for ten days. Patients of the comparison group (14 men and 16 women, the mean age 55.4±18.6 and 50.3±18.6 for men and women, respectively) received the original preparation of ademetionine 1000 mg intravenously also for 10 days. The groups were matching in terms of gender, age, and biochemical parameters (p >0.05). Visits and assessment of complaints and biochemical indicators were carried out according to the approved study design. Results. The dynamic examination of patients in both groups in 10 days after the therapy start demonstrated a significant decrease in the laboratory indicators and skin manifestations of jaundice (p <0.05). The significant positive dynamics of intrahepatic cholestasis was determined in both groups. Conclusions. The results of the use of ademetionine give reason to positively evaluate its effectiveness in patients with intrahepatic cholestasis syndrome against the background of drug induced liver damage in the treatment of COVID 19. The studied preparation of ademetionine is comparable to the reference one.