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Natural History of Patients Taking Rifaximin-α for Recurrent Hepatic Encephalopathy and Risk of Future Overt Episodes and Mortality: A Post-hoc Analysis of Clinical Trials Data

Lookup NU author(s): Dr James Orr, Dr Mark Hudson

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Abstract

Purpose: Hepatic encephalopathy (HE) is a complication of cirrhosis signaling decompensation and is associated with mortality. There has been little characterization of HE once an incident episode has occurred and of what effect the transition to overt HE might have on outcomes. We characterized the relationships between the number of previous HE episodes and risk of subsequent episodes and mortality to better understand the natural history of HE.Methods: Data on 321 patients from a 24-month, open-label, nonrandomized trial evaluating the long-term safety profile and tolerability of twice-daily rifaximin-alpha, 550 mg were analyzed. Patients were followed for a mean of 1.5 years (total follow-up of 467 years).Findings: There were a total of 334 HE episodes and 75 deaths, corresponding to unadjusted event rates of 715 HE episodes and 161 deaths per 1000 years. There was a direct association between rate of subsequent HE episodes and number of prior HE episodes; the risk of subsequent HE episodes was elevated for each additional HE episode (hazard ratio = 1.23; 95% CI, 1.19-1.29). There was a nonlinear, nonmonotonic relationship between risk of death and number of prior HE episodes; risk initially increased, then decreased, and finally plateaued as the number of prior HE episodes increased. (C) 2016 Elsevier HS Journals, Inc. All rights reserved.


Publication metadata

Author(s): Bannister CA, Orr JG, Reynolds AV, Hudson M, Conway P, Radwan A, Morgan CL, Currie CJ

Publication type: Article

Publication status: Published

Journal: Clinical Therapeutics

Year: 2016

Volume: 38

Issue: 5

Pages: 1081-1089

Print publication date: 01/05/2016

Online publication date: 30/04/2016

Acceptance date: 23/03/2016

ISSN (print): 0149-2918

ISSN (electronic): 1879-114X

Publisher: Elsevier

URL: http://dx.doi.org/10.1016/j.clinthera.2016.03.033

DOI: 10.1016/j.clinthera.2016.03.033


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