Randomised clinical trial: rifaximin improves health‐related quality of life in cirrhotic patients with hepatic encephalopathy – a double‐blind placebo‐controlled study

Aliment Pharmacol Ther 2011; 34: 853–861 Summary Background  Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol‐related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of...

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Published inAlimentary pharmacology & therapeutics Vol. 34; no. 8; pp. 853 - 861
Main Authors Sanyal, A., Younossi, Z. M., Bass, N. M., Mullen, K. D., Poordad, F., Brown, R. S., Vemuru, R. P., Mazen Jamal, M., Huang, S., Merchant, K., Bortey, E., Forbes, W. P.
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Published Oxford, UK Blackwell Publishing Ltd 01.10.2011
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Abstract Aliment Pharmacol Ther 2011; 34: 853–861 Summary Background  Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol‐related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life. Aim  To evaluate the effect of rifaximin on health‐related quality of life (HRQL) in cirrhotic patients with HE. Methods  Patients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time‐weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment. Results  The time‐weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P‐values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P‐values were <0.0001). Conclusion  Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy (ClinicalTrials.gov identifier NCT00298038).
AbstractList BACKGROUNDHepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life.AIMTo evaluate the effect of rifaximin on health-related quality of life (HRQL) in cirrhotic patients with HE.METHODSPatients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time-weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment.RESULTSThe time-weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P-values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P-values were <0.0001).CONCLUSIONRifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy.
Aliment Pharmacol Ther 2011; 34: 853–861 Summary Background  Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol‐related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life. Aim  To evaluate the effect of rifaximin on health‐related quality of life (HRQL) in cirrhotic patients with HE. Methods  Patients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time‐weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment. Results  The time‐weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P‐values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P‐values were <0.0001). Conclusion  Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy (ClinicalTrials.gov identifier NCT00298038).
Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life. To evaluate the effect of rifaximin on health-related quality of life (HRQL) in cirrhotic patients with HE. Patients with cirrhosis in remission from HE (Conn score = 0 or 1) and a documented history of recurrent HE episodes (≥2 within 6 months of screening) were randomised to rifaximin 550 mg twice daily (N = 101) or placebo (N = 118) for 6 months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4 weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time-weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment. The time-weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P-values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P-values were <0.0001). Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy.
Aliment Pharmacol Ther 2011; 34: 853-861 Background Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is characterised by cognitive, psychiatric and motor impairments. Recurrent bouts of overt HE negatively impact daily functioning and quality of life. Aim To evaluate the effect of rifaximin on health-related quality of life (HRQL) in cirrhotic patients with HE. Methods Patients with cirrhosis in remission from HE (Conn score=0 or 1) and a documented history of recurrent HE episodes ( greater than or equal to 2 within 6months of screening) were randomised to rifaximin 550mg twice daily (N=101) or placebo (N=118) for 6months. Concomitant lactulose was permitted during the study. The Chronic Liver Disease Questionnaire (CLDQ) was administered every 4weeks, and time for occurrence of HE breakthrough was recorded. A longitudinal analysis using time-weighted averages of the CLDQ scores normalised by days on study therapy was used to evaluate the effect of treatment on HRQL, and between HE outcomes (HE recurrence, yes/no) irrespective of treatment. Results The time-weighted averages of the overall CLDQ score and each domain score were significantly higher in the rifaximin group vs. placebo (P-values ranged from 0.0087 to 0.0436); and were significantly lower in patients who experienced HE breakthrough compared to those who remained in remission (P-values were <0.0001). Conclusion Rifaximin significantly improved HRQL in patients with cirrhosis and recurrent hepatic encephalopathy. A lower HRQL may predict recurrence of hepatic encephalopathy (ClinicalTrials.gov identifier NCT00298038).
Author Younossi, Z. M.
Vemuru, R. P.
Bass, N. M.
Mazen Jamal, M.
Brown, R. S.
Huang, S.
Mullen, K. D.
Sanyal, A.
Merchant, K.
Bortey, E.
Poordad, F.
Forbes, W. P.
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Issue 8
Keywords Human
Cirrhosis
Placebo
Double blind study
Digestive diseases
Hepatic disease
Clinical trial
Antituberculous agent
Rifaximin
Antibacterial agent
Health-Related Quality of Life
Hepatic encephalopathy
Language English
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2011 Blackwell Publishing Ltd.
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Snippet Aliment Pharmacol Ther 2011; 34: 853–861 Summary Background  Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral...
Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver disease, and is...
Aliment Pharmacol Ther 2011; 34: 853-861 Background Hepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis,...
BACKGROUNDHepatic encephalopathy (HE) is a brain disorder that often results from cirrhosis due to viral hepatitis, metabolic and alcohol-related liver...
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SubjectTerms Aged
Biological and medical sciences
Canada
Digestive system
Double-Blind Method
Female
Gastroenterology. Liver. Pancreas. Abdomen
Gastrointestinal Agents - therapeutic use
Hepatic Encephalopathy - drug therapy
Hepatic Encephalopathy - physiopathology
Humans
Linear Models
Liver Cirrhosis - drug therapy
Liver Cirrhosis - physiopathology
Liver. Biliary tract. Portal circulation. Exocrine pancreas
Male
Medical sciences
Middle Aged
Other diseases. Semiology
Pharmacology. Drug treatments
Quality of Life
Rifamycins - therapeutic use
Severity of Illness Index
Surveys and Questionnaires
Treatment Outcome
United States
Title Randomised clinical trial: rifaximin improves health‐related quality of life in cirrhotic patients with hepatic encephalopathy – a double‐blind placebo‐controlled study
URI https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fj.1365-2036.2011.04808.x
https://www.ncbi.nlm.nih.gov/pubmed/21848797
https://search.proquest.com/docview/1367481435
https://search.proquest.com/docview/900778719
Volume 34
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