Treatment with Metadoxine and its impact on early mortality in patients with severe alcoholic hepatitis



Document title: Treatment with Metadoxine and its impact on early mortality in patients with severe alcoholic hepatitis
Journal: Annals of hepatology
Database: PERIÓDICA
System number: 000414222
ISSN: 1665-2681
Authors: 1
2
2
3
1
4
1
Institutions: 1Hospital General de México, Departamento de Gastroenterología, México, Distrito Federal. México
2Hospital General de México, Departamento de Medicina Interna, México, Distrito Federal. México
3Fundación Mexicana para la Salud, México, Distrito Federal. México
4Universidad Nacional Autónoma de México, Facultad de Medicina, México, Distrito Federal. México
Year:
Season: May-Jun
Volumen: 13
Number: 3
Pages: 343-32
Country: México
Language: Inglés
Document type: Artículo
Approach: Analítico, descriptivo
English abstract Despite treatment with glucocorticoids, mortality remains high in patients with severe alcoholic hepatitis. Oxidative stress and depletion of mitochondrial glutathione are implicated factors in liver injury. The aim of this study was to evaluate the impact of the addition of metadoxine, a drug which possesses a multifactorial mechanism of action, including antioxidant properties, to standard treatment with glucocorticoids in patients with severe alcoholic hepatitis. Material and methods. This randomized open label clinical trial was performed in Mexico’s General Hospital (Registry Key DIC/10/107/03/043). We randomized 70 patients with severe alcoholic hepatitis. The first group received prednisone (40 mg/day), and the second group received prednisone (40 mg/day) plus metadoxine tablets (500 mg three times daily). The duration of treatment in both groups was 30 days. Survival at 30 and 90 days, development of complications, adverse events and response to treatment (Lille model) were assessed. Results. In the group receiving metadoxine, significant improvements were observed, as follows: survival at 30 days (74.3 vs. 45.7%, P = 0.02); survival at 90 days (68.6 vs. 20.0%, P = 0.0001). There was less development or progression of encephalopathy (28.6 vs. 60.0%, P = 0.008) and hepatorenal syndrome (31.4 vs. 54.3%, P = 0.05), and the response to treatment (Lille model) was higher in the metadoxine group (0.38 vs. 0.63, P = 0.001; 95% CI 0.11 to 0.40). There were no differences between groups regarding the development or progression of variceal hemorrhage or infection. The incidence of adverse events, mainly gastrointestinal, was similar in both groups. Conclusions. Addition of metadoxine to glucocorticoid treatment improves the short-term survival of patients with severe alcoholic hepatitis and diminishes the development or progression of encephalopathy and hepatorenal syndrome
Disciplines: Medicina
Keyword: Farmacología,
Gastroenterología,
Terapéutica,
Hepatitis alcohólica,
Estrés oxidativo,
Metadoxina,
Glucocorticoides,
Sobrevida
Keyword: Medicine,
Gastroenterology,
Pharmacology,
Therapeutics,
Alcoholic hepatitis,
Oxidative stress,
Metadoxine,
Glucocorticoids,
Survival
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