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


Por: Higuera-De la Tijera F., Servín-Caamaño A.I., Cruz-Herrera J., Serralde-Zúñiga A.E., Abdo-Francis J.M., Gutiérrez-Reyes G., Pérez-Hernández J.L.

Publicada: 1 may 2014
Categoría: Hepatology

Resumen:
Background Et Aim. 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/101107/03/043). 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% Cl 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.

Filiaciones:
Higuera-De la Tijera F.:
 Gastroenterology Department, Hospital General de México, Mexico

Servín-Caamaño A.I.:
 Internal Medicine Department, Unit 108, Hospital General de México, Mexico

Cruz-Herrera J.:
 Internal Medicine Department, Unit 108, Hospital General de México, Mexico

Serralde-Zúñiga A.E.:
 Fundación Mexicana para la Salud A.C., Mexico

Abdo-Francis J.M.:
 Gastroenterology Department, Hospital General de México, Mexico

Gutiérrez-Reyes G.:
 Univ Nacl Autonoma Mexico, Fac Med, Lab Higado Pancreas & Motilidad HIPAM, Mexico City 04510, DF, Mexico

Pérez-Hernández J.L.:
 Gastroenterology Department, Hospital General de México, Mexico
ISSN: 16652681
Editorial
Mexican Association of Hepatology, PUNTE DE PIEDRA 150, COLONIA TORIELLO GUERRA, MEXICO, DF CP 14040, MEXICO, México
Tipo de documento: Article
Volumen: 13 Número: 3
Páginas: 343-352
WOS Id: 000341467200005
ID de PubMed: 24756009
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