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A Pilot Study Utilizing Nitazoxanide for Hepatic Encephalopathy in Chronic Liver Failure

2008; Lippincott Williams & Wilkins; Volume: 103; Linguagem: Inglês

10.14309/00000434-200809001-00392

1572-0241

Patrick Basu, Krishna Rayapudi, J. Péricles Esteves, Robert N. Brown,

Drug-Induced Hepatotoxicity and Protection

Purpose: Hepatic encephalopathy (HE) is an alarming sign of liver failure (LF) and warrants liver transplantation. Subclinical hepatic encephalopathy (SHE) is seen in 30% of patients with chronic LF (CLF). Oral disaccharides and antibiotics are standard therapy. The longer duration of therapy with antibiotics is associated with side-events leading to treatment cessation. Nitazoxanide (NTZ) is a thiazolide antibiotic with excellent safety profile that targets anaerobes in the intestinal tract. We postulated NTZ as an agent for initial therapy of HE. Methods: 20 patients with cirrhosis were enrolled. Fulminant LF, HIV, MELD > 24, sepsis, recent GI bleed, TIPS or surgical shunts and narcotic use were excluded. All underwent Trail testing, Object Recognition Test (ORT) and Modified Encephalopathy Scale (MES) (mental status, sleep, confusion and comprehension). All were treated with oral lactulose 30 ml and NTZ 500 mg twice daily for 14 days. MES and ORT were repeated weekly. Results: Population statistics: mean age 55, 85% male, mean MELD –15.6. Disease etiology: alcoholic cirrhosis (9), hepatitis C (9), autoimmune hepatitis (1) and primary biliary cirrhosis (1). 16/20 patients had decompensated disease with grade II encephalopathy and 4/20 patients had SHE. In total, 19/20 patients completed the study, one died following urgent transplant. Patient performance on MES and ORT improved in 79% (15/19) and 63% (12/19) respectively on NTZ. Conclusion: NTZ was well tolerated and clinically effective for HE. The relative contribution of NTZ and lactulose to the efficacy are unclear. A randomized, placebo-controlled clinical trial is needed to validate the use of NTZ.