Ademetionine 200mg tablets

The article presents the detailed analysis of literature concerning ademetionine physiological role in biochemical processes. There was conducted pathophysiological substantiation of Heptral appropriateness in treatment of liver cholestatic diseases, alcoholic liver disease, nonalcoholic fatty liver disease, liver drug injuries, viral hepatitis. There was described antidepressant properties of Heptral® and its significance in different psychic pathology as well. Pathophysiological and experimental data were illustrated with results of clinical trials, which justify effectiveness of the preparation in treatment of liver diseases, depression, abstinent syndrome etc. There were cited trial results regarding Heptral® safety and prospects of its use in the clinical practice. The data of experimental and clinical studies demonstrating anti-inflammatory, antifibrotic, cytoprotective, antiviral activity are presented. The results of a recently presented systematic review are considered, which proved the ability of ademetionine, regardless of the route of administration (parenteral or enteral), to effectively offset the manifestations of fatigue caused by various liver diseases, both in the short and long term. It has been proved that the antidepressant effect of ademetionine is comparable to the efficacy of monotherapy with imipramine or escitalopram; combined administration of ademetionine and probiotic strains for three months improves the quality of life of patients with subclinical, mild and moderate depression who are not sensitive to or cannot tolerate antidepressants. Special attention is paid to the antioxidant activity of ademetionine, which allows its use in neoplastic pathology as an adjuvant agent in glioblastoma, colorectal cancer, prostate cancer, multiple myeloma. It was proved that ademetionine reduces fatigue in patients with colorectal cancer against the background of chemotherapy regimens based on the use of oxaliplatin.

Abstract licence: CC BY 4.0

Objective — to prove that the Hepametion, enteric‑dissolving tablets of 500 mg, produced by JSC Kyivmedpreparat (Ukraine), is not inferior in effectiveness to the original drug ademetionine, enteric‑dissolving tablets of 500 mg, in patients with non‑alcoholic steatohepatitis with intrahepatic cholestasis syndrome. Materials and methods. 110 patients who met the inclusion/exclusion criteria were randomized into the study. They were divided into 2 groups. The patients of the main group, consisting of (28 (51.9%) men and 26 (48.1%) women with the mean age 46.37±9.86  years) were administered the generic preparation of ademetionine Hepametion (Kyivmedpreparat) tablets of 500 mg, the patients of the control group — the original drug of ademetionine 500 mg. Initial therapy lasted in both groups for 14 days (± 3 days) in a daily dose of 1000 mg. Maintenance therapy was carried out from the 15th day (± 3 days) to the 60th day (± 3 days): patients in the main group received Hepametion 1 tablet (500 mg) orally between meals 3 times a day (daily dose — 1500 mg); and patients of the control group received the reference drug 1 tablet (500 mg) orally between meals 3 times a day (daily dose — 1500 mg). Patients of both groups were comparable in terms of demographic and anthropometric characteristics, assessments of the severity of the condition, severity and presence of complaints and symptoms, vital functions, results of instrumental and laboratory examinations, concomitant therapy, and pathology (p >0.05). A confirmed diagnosis of non‑alcoholic steatohepatitis with intrahepatic cholestasis syndrome was established according to the national and international recommendations. Results. It has been evidenced, that the effectiveness of Hepametion, enteric‑dissolving tablets 500 mg, with the course of 2‑month use in the treatment of patients with non‑alcoholic steatohepatitis with intrahepatic cholestasis syndrome is not inferior to that of the original ademetionine. Difference between the groups was not significant (р >0.05). The course of 2‑month ademetionine therapy of patients with non‑alcoholic steatohepatitis with intrahepatic cholestasis syndrome promoted normalization of markers of severity of intrahepatic cholestasis syndrome (level of direct bilirubin and activity of AP and GGT), as well as to the reduction of clinical symptoms of cholestasis (р 0.05).  

Abstract licence: CC BY-ND 4.0

Abstract Background Metabolic-associated fatty liver disease (MAFLD) is a prevalent chronic liver condition with limited approved pharmacological treatments [1]. Ursodeoxycholic acid (UDCA) and ademetionine show variable efficacy, primarily on liver enzymes. This study presents a preliminary analysis comparing the efficacy of a novel dietary supplement, Gepaktiv, against these comparators in MAFLD patients. Methods In this open-label, randomized controlled trial ( clinicaltrials.gov NCT07068191 and ITMCTR 2025001469), 19 patients with MAFLD, confirmed by hepatomegaly (liver size ≥3 cm above normal by ultrasound), elevated alanine aminotransferase (ALT, 90–150 U/L), and FibroScan results (steatosis ≥260 dB/m, fibrosis ≥11 kPa), were allocated to Gepaktiv (n=6, 1500 mg/day), UDCA (n=7, 10 mg/kg/day), or Ademetionine (n=6, orally 400 mg 2 times a day) for 15 days. Patients with significant alcohol consumption (>20 g/day for women, >30 g/day for men) were excluded. Primary outcomes were median changes from baseline to day 15 in ALT, aspartate aminotransferase (AST), liver size (craniocaudal diameter, cm, via ultrasound), steatosis (controlled attenuation parameter, CAP, dB/m), and fibrosis (transient elastography, kPa). Results The Gepaktiv group showed median [IQR] reductions of ALT -48.9 [-54.0 to -35.0] U/L, AST - 62.8 [-66.0 to -44.0] U/L, liver size -1.9 [-2.0 to -1.2] cm, and steatosis -32.5 [-45.0 to -30.0] dB/m. These reductions were significantly greater compared to both UDCA and Ademetionine groups (p < 0.01 for ALT, AST, and liver size; p < 0.05 for steatosis). Fibrosis reduction was minimal and not statistically significant between groups. Conclusion The Gepaktiv group was associated with greater improvements in biochemical and imaging markers of MAFLD compared to UDCA and Ademetionine in this preliminary analysis. These findings warrant further investigation in larger, long-term trials. Note : These preliminary results have not been peer-reviewed and should not guide clinical practice.

Abstract licence: CC BY-NC-ND 4.0

Liver injury caused by antitumor therapy is a common disorder in patients with malignancies. It is due to the introduction of new innovative drugs into the treatment, which significantly increases the duration and quality of life, but also the frequency of side effects with liver damage of varying severity. The rate of hepatotoxicity during chemotherapy ranges from 5% to 100%. The spectrum of morphological changes in the liver is diverse and includes acute and chronic liver injury with damage to hepatocytes and outcome in fibrosis. The clinical features of the diagnosis of various types, variants, and phenotypes of drug-induced liver injury in the chemotherapy of solid tumors and hematological malignancies are addressed. The article reviews the literature on concomitant treatment with ademetionine to reduce metabolic disorders and hepatic toxicity caused by cytotoxic therapy. Clinical and biochemical effects persist for a long time after treatment. The results of using ademetionine to correct clinical symptoms such as fatigue are described in detail. The presented data supports a practical revision of the role of concomitant therapy with ademetionine to prevent and reduce the manifestations of hepatotoxicity induced by polychemotherapy. This approach contributes to a personalized approach to patients with malignancies, thereby significantly improving medical care and increasing the duration and quality of life.

Abstract licence: CC BY-NC-SA 4.0