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The objective of this report was to perform a systematic review of the beneficial and harmful effects of rifaximin for reducing the risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age who are at risk of HE recurrence despite the use of lactulose, or who are intolerant to lactulose.
Contents
- Clinical Review Report
- ABBREVIATIONS
- EXECUTIVE SUMMARY
- 1. INTRODUCTION
- 2. OBJECTIVES AND METHODS
- 3. RESULTS
- 4. DISCUSSION
- 5. CONCLUSIONS
- APPENDIX 1 PATIENT INPUT INFORMATION
- APPENDIX 2 LITERATURE SEARCH STRATEGY
- APPENDIX 3 EXCLUDED STUDIES
- APPENDIX 4 DETAILED OUTCOME DATA
- APPENDIX 5 VALIDITY OF OUTCOME MEASURES
- APPENDIX 6 SUMMARY OF OPEN-LABEL MAINTENANCE TRIAL (STUDY 3002)
- REFERENCES
- Pharmacoeconomic Review Report
- CDEC Final Recommendation
This report was prepared by the Canadian Agency for Drugs and Technologies in Health (CADTH). Through the CADTH Common Drug Review (CDR) process, CADTH undertakes reviews of drug submissions, resubmissions, and requests for advice, and provides formulary listing recommendations to all Canadian publicly funded federal, provincial, and territorial drug plans, with the exception of Quebec.
The report contains an evidence-based clinical and/or pharmacoeconomic drug review, based on published and unpublished material, including manufacturer submissions; studies identified through independent, systematic literature searches; and patient-group submissions. In accordance with CDR Update — Issue 87, manufacturers may request that confidential information be redacted from the CDR Clinical and Pharmacoeconomic Review Reports.
The information in this report is intended to help Canadian health care decision-makers, health care professionals, health systems leaders, and policy-makers make well-informed decisions and thereby improve the quality of health care services. The information in this report should not be used as a substitute for the application of clinical judgment with respect to the care of a particular patient or other professional judgment in any decision-making process, nor is it intended to replace professional medical advice. While CADTH has taken care in the preparation of this document to ensure that its contents are accurate, complete, and up-to-date as of the date of publication, CADTH does not make any guarantee to that effect. CADTH is not responsible for the quality, currency, propriety, accuracy, or reasonableness of any statements, information, or conclusions contained in the source documentation. CADTH is not responsible for any errors or omissions or injury, loss, or damage arising from or relating to the use (or misuse) of any information, statements, or conclusions contained in or implied by the information in this document or in any of the source documentation.
This document is intended for use in the context of the Canadian health care system. Other health care systems are different; the issues and information related to the subject matter of this document may be different in other jurisdictions and, if used outside of Canada, it is at the user’s risk. This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada.
CADTH takes sole responsibility for the final form and content of this document, subject to the limitations noted above. The statements and conclusions in this document are those of CADTH and not of its advisory committees and reviewers. The statements, conclusions, and views expressed herein do not necessarily represent the views of Health Canada or any Canadian provincial or territorial government. Production of this document is made possible by financial contributions from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Saskatchewan, and Yukon.
- NLM CatalogRelated NLM Catalog Entries
- Efficacy of rifaximin versus lactulose for reducing the recurrence of overt hepatic encephalopathy and hopitalizations in cirrhosis.[Rev Med Chir Soc Med Nat Iasi....]Efficacy of rifaximin versus lactulose for reducing the recurrence of overt hepatic encephalopathy and hopitalizations in cirrhosis.Irimia R, Trifan A. Rev Med Chir Soc Med Nat Iasi. 2012 Oct-Dec; 116(4):1021-7.
- A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of overt hepatic encephalopathy.[Am J Gastroenterol. 2013]A randomized, double-blind, controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of overt hepatic encephalopathy.Sharma BC, Sharma P, Lunia MK, Srivastava S, Goyal R, Sarin SK. Am J Gastroenterol. 2013 Sep; 108(9):1458-63. Epub 2013 Jul 23.
- RiMINI - the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial.[Trials. 2016]RiMINI - the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial.Schulz C, Schütte K, Kropf S, Schmitt FC, Vasapolli R, Kliegis LM, Riegger A, Malfertheiner P. Trials. 2016 Feb 29; 17(1):111. Epub 2016 Feb 29.
- Review Combination therapy for the treatment and prevention of hepatic encephalopathy.[Ann Pharmacother. 2012]Review Combination therapy for the treatment and prevention of hepatic encephalopathy.Mohammad RA, Regal RE, Alaniz C. Ann Pharmacother. 2012 Nov; 46(11):1559-63. Epub 2012 Oct 23.
- Review Update on management of patients with overt hepatic encephalopathy.[Hosp Pract (1995). 2013]Review Update on management of patients with overt hepatic encephalopathy.Chacko KR, Sigal SH. Hosp Pract (1995). 2013 Aug; 41(3):48-59.
- Rifaximin (Zaxine)Rifaximin (Zaxine)
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