Metadoxine as a Therapy for Severe Alcoholic Hepatitis

Phase 4 Completed 135 enrolled Hospital General de Mexico

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether metadoxine is effective for improve survival and reduced oxidative stress in patients with severe alcoholic hepatitis.

Timeline

Start: 2010-04
Primary completion: 2014-09
Completion: 2014-09

Outcome

Met primary endpoint

paper PTX+MTD 59.4% vs PTX 33.3%, P = 0.04 PMID 25945012 ↗

paper PDN+MTD 68.6% vs PDN 20%, P = 0.0001 PMID 25945012 ↗

paper CONCLUSION: MTD improves the 3- and 6-mo survival rates in patients with severe AH. PMID 25945012 ↗

Publications

Higuera-de la Tijera F, Servin-Caamano AI, Serralde-Zuniga AE, Cruz-Herrera J, Perez-Torres E, Abdo-Francis JM, Salas-Gordillo F, Perez-Hernandez JL. Metadoxine improves the three- and six-month survival rates in patients with severe alcoholic hepatitis. World J Gastroenterol. 2015 Apr 28;21(16):4975-85. doi: 10.3748/wjg.v21.i16.4975.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metadoxine	Unknown	500 mg	Oral
Subject	Pentoxifylline	Small molecule	400 mg	Oral
Subject	Prednisone	Other / unclassified	40 mg	Oral