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. 2019 Jun 23:12:1756284819858256.
doi: 10.1177/1756284819858256. eCollection 2019.

The efficacy and safety of rifaximin-α: a 2-year observational study of overt hepatic encephalopathy

Rosalie C Oey  1 , Lennart E M Buck  2 , Nicole S Erler  3 , Henk R van Buuren  2 , Robert A de Man  2
Affiliations

The efficacy and safety of rifaximin-α: a 2-year observational study of overt hepatic encephalopathy

Rosalie C Oey et al. Therap Adv Gastroenterol. .

Abstract

Background: After 5 years since the registration of rifaximin-α as a secondary prophylaxis for overt hepatic encephalopathy (HE) in the Netherlands, we aimed to evaluate the use of hospital resources and safety of rifaximin-α treatment in a real-world setting.

Methods: We carried out prospective identification of all patients using rifaximin-α for overt HE. We assessed hospital resource use, bacterial infections, and adverse events during 6-month episodes before and after rifaximin-α initiation.

Results: During 26 months we included 127 patients [71.7% male; median age 60.8 years (interquartile range: 56.2-66.1); median model for end-stage liver disease (MELD) score 15.0 (interquartile range: 12.1-20.4); 98% using lactulose treatment]. When comparing the first 6 months after rifaximin-α initiation with the prior 6 months, HE-related hospital admissions decreased (0.86 to 0.41 admissions/patient; p < 0.001), as well as the mean length of stay (8.85 to 3.79 bed days/admission; p < 0.001). No significant differences were found regarding HE-related intensive care unit admissions (0.09 to 0.06 admission/patient; p = 0.253), stay on the intensive care unit (0.43 to 0.57 bed days/admission; p = 0.661), emergency department visits (0.66 to 0.51 visits/patient; p = 0.220), outpatient clinic visits (2.49 to 3.30 bed visits/patient; p = 0.240), or bacterial infections (0.41 to 0.35 infections/patient; p = 0.523). Adverse events were recorded in 2.4% of patients.

Conclusions: The addition of rifaximin-α to lactulose treatment was associated with a significant reduction in the number and length of HE-related hospitalizations for overt HE. Rifaximin-α treatment was well tolerated.

Keywords: efficacy; end-stage liver disease; healthcare utilization; hepatic encephalopathy; rifaximin-α; safety.

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Conflict of interest statement

Conflict of interest statement: The authors have no conflict of interest. Sponsors did not actively participate in content development but reviewed the manuscript for scientific accuracy.

Figures

Figure 1.
Figure 1.
Flow chart of study inclusion.
Figure 2.
Figure 2.
Differences in proportion of patients with at least one hospital visit or hospitalization during 6-month episodes before and after initiation of rifaximin-α treatment. A&E, accident and emergency; HE, hepatic encephalopathy.
Figure 3.
Figure 3.
Kaplan–Meier curve showing the proportion (red line) of patients using rifaximin-α after initiation of treatment.
See this image and copyright information in PMC

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