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  • The impact of rifaximin-α on the hospital resource use associated with the management of patients with hepatic encephalopathy: a retrospective observational study (IMPRESS)

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Liver
Research
The impact of rifaximin-α on the hospital resource use associated with the management of patients with hepatic encephalopathy: a retrospective observational study (IMPRESS)
  1. Mark Hudson1,
  2. Amr Radwan2,
  3. Paola Di Maggio2,
  4. Riccardo Cipelli3,
  5. Stephen D Ryder4,
  6. John F Dillon5,
  7. William Jonathan Cash6,
  8. Robert T Przemioslo7,
  9. Mark Wright8,
  10. Debbie L Shawcross9,
  11. Rajiv Jalan10,
  12. Sushma Saksena11,
  13. Michael Allison12,
  14. Paul Richardson13,
  15. Elizabeth Farrington14,
  16. Richard J Aspinall15
  1. 1Liver Unit, Freeman Hospital, Newcastle upon Tyne, UK
  2. 2UK Medical Affairs, Norgine, Harefield, UK
  3. 3pH Associates, Marlow, UK
  4. 4NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and The University of Nottingham, Nottingham, UK
  5. 5Department of Gastroenterology, Ninewells Hospital and The School of Medicine, University of Dundee, Dundee, UK
  6. 6The Liver Unit, Royal Victoria Hospital, Belfast, UK
  7. 7Department of Gastroenterology, Southmead Hospital, Bristol, UK
  8. 8Department of Hepatology, University Hospital Southampton, Southampton, UK
  9. 9Institute of Liver Studies and Transplantation, King's College London School of Medicine at King's College Hospital, London, UK
  10. 10Liver Failure Group, University College London Institute for Liver and Digestive Health, Royal Free Hospital, London, UK
  11. 11Department of Gastroenterology, University Hospital of North Durham, Durham, UK
  12. 12Cambridge Biomedical Research Centre, Addenbrooke's Hospital, Cambridge, UK
  13. 13Department of Gastroenterology and Hepatology, Royal Liverpool & Broadgreen University Hospitals NHS Trust, Liverpool, UK
  14. 14Department of Gastroenterology & Hepatology, Royal Cornwall Hospital, Cornwall, UK
  15. 15Department of Gastroenterology & Hepatology, Queen Alexandra Hospital, Portsmouth, UK
  1. Correspondence to Dr Paola Di Maggio, UK Medical Affairs, Norgine, Moorhall Road, Harefield, Uxbridge, London UB9 6NS, UK; pdimaggio{at}norgine.com

Abstract

Objective To compare all-cause and liver-related hospital resource use in the 6 and 12 months pre-rifaximin-α and post-rifaximin-α initiation in UK patients with hepatic encephalopathy (HE).

Design A UK multicentre, retrospective, observational study. Patients' medical records were reviewed for demographics, clinical outcomes and adverse events (AEs) to rifaximin-α. Details of hospital admissions/attendances in the 6 and 12 months pre-rifaximin-α and post-rifaximin-α initiation were extracted from hospital electronic databases.

Setting 13 National Health Service centres.

Patients 207 patients with HE who initiated rifaximin-α between July 2008 and May 2014. Hospital resource use data were available for 145/207 patients.

Main outcome measure Change in mean number of liver-related hospital bed days/patient (total and critical care) between the 6 months pre-rifaximin-α and post-rifaximin-α initiation.

Results Comparing the 6 months pre-rifaximin-α and post-rifaximin-α initiation in alive patients at the end of the observation period (N=114): there were significant reductions in the mean number of hospitalisations/patient (liver-related 1.3 to 0.5, p<0.001; all-cause 1.9 to 0.9, p<0.001), hospital bed days/patient (liver-related 17.8 to 6.8, p<0.001; all-cause 25.4 to 10.6, p<0.001), 30-day hospital readmissions/patient (liver-related 0.5 to 0.2, p=0.039; all-cause 0.8 to 0.4, p=0.024) and emergency department (ED) attendances/patient (all-cause, 1.0 to 0.5, p<0.001). The mean critical care bed days/patient reduced significantly for all-cause admissions (1.3 to 0.3, p=0.049); non-significant reduction for liver-related admissions. 4% of patients (9/207) developed AEs.

Conclusions In UK clinical practice, treatment with rifaximin-α for HE is well-tolerated and associated with significant reductions in hospitalisations, bed days (including critical care), ED attendances and 30-day readmissions.

  • LIVER CIRRHOSIS
  • HEPATIC ENCEPHALOPATHY
  • HEALTH ECONOMICS
  • ANTIBIOTIC THERAPY

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/flgastro-2016-100792

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    Footnotes

    • Contributors MH and RJA contributed to the design of the study and the collection, analysis and interpretation of the study data. AR contributed to the design of the study and the analysis and interpretation of the study data. PDM contributed to the analysis and interpretation of the study data, to the publication planning and management. RC analysed the data. SDR, JFD, RTP, RJ, PR and EF contributed to the collection of the study data. WJC, DLS and MA contributed to the design of the study and the collection of the study data. MW contributed to the collection and interpretation of the study data. SS and PR contributed to the design of the study and the collection and interpretation of the study data. All authors critically reviewed the manuscript and approved the final version for publication.

    • Funding This study was sponsored and funded by Norgine. Norgine personnel were involved in the design of the study, analysis and interpretation of the study data, review of the draft manuscript and approval of the final version. pH Associates, an independent research consultancy, was commissioned by Norgine to provide support with the design and conduct of the study, data analysis and medical writing.

    • Competing interests AR was an employee of Norgine at the time this work was undertaken. PDM is an employee of Norgine. RC is an employee of pH Associates, which was commissioned by Norgine to provide support with the design and conduct of the study, data analysis and medical writing. JFD has received honoraria for lectures from Norgine. DS and MH have served as a speaker, consultant and an advisory board member for Norgine. RJ: Inventor (Ornithine phenyl acetate for the treatment of hepatic encephalopathy (licensed to Ocera Therapeutics)); Consultancy and Speaker Fees (Ocera Therapeutics, Norgine); Research Collaboration (Ocera Therapeutics, Takeda); Chief Investigator (Sequana medical sponsored study of alfapump); Founder (UCL spin-out company, Yaqrit (Yaq-001, TLR4 antagonist, DIALIVE: Albumin exchange and Endotoxin removal)). MA and RJA have attended UK Advisory Boards for Norgine. EF has served as consultant and speaker for Norgine. SS has received travel support from Norgine, AbbVie, Merck and Roche and attended, in advisor capacity, two meetings hosted by Norgine related to research in HE. SDR, WJC, RTP, MW and PR have no competing interests.

    • Ethics approval Proportionate Review Sub-Committee of the West of Scotland 3 Research Ethics Committee (reference 14/WS/1017).

    • Provenance and peer review Not commissioned; externally peer reviewed.

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