AMSTERDAM, June 11, 2019 /PRNewswire/ --
- Rifaximin significantly reduced the incidence of all-cause hospital admissions in HE patients with advanced cirrhosis on the waiting list for liver transplantation
- Rifaximin contributed to improved outcomes in HE patients on the waiting list helping patients stay out of hospital for longer
Norgine B.V. highlighted results of an independent, investigator initiated trial showing significant reductions in the number and length of hospital admissions when rifaximin is used to treat end-stage liver disease patients with overt hepatic encephalopathy (HE).
The real world study published today in the peer-reviewed journal Alimentary Pharmacology and Therapeutics showed that rifaximin, when prescribed for the treatment of acute or chronic HE, or for secondary prevention of HE in patients with advanced cirrhosis who are on the waiting list for liver transplantation, significantly reduced the incidence of all-cause hospital admissions (mean length of stay: 9 days; 95%CI 6-12 in rifaximin-treated patients vs. 14 days; 95%CI 7-21 in the naïve group). This included serious medical complications such as spontaneous bacterial peritonitis (an acute infection in the abdomen that occurs without warning or a clear cause), ascites (an abnormal build-up of fluid in the abdomen that can cause infection) and variceal bleeding (dilated blood vessels in the oesophagus or stomach that can cause internal bleeding). On average, HE patients on the transplant waiting list who did not receive rifaximin tended to stay 5 days longer in hospital when admitted due to complications.
Patients on rifaximin also avoided re-hospitalisation for longer and were less likely to require urgent liver transplantation due to deterioration of their condition (odds ratio 0.29; 95% CI 0.89-0.93).
"End-stage liver disease patients already have a poor prognosis and low quality of life; hepatic encephalopathy is a further devastating complication. This study demonstrates the potential value of rifaximin for those vulnerable patients and its impact on improving outcomes and reducing the need for hospitalisation," said Dr. Debbie Shawcross, Lead Investigator of the study, Reader and Honorary Consultant in Hepatology at the Department of Liver Sciences, King's College London.
The study evaluated for two years 101 patients who had at least two episodes of overt HE whilst they were waiting for a liver transplant. The use of lactulose, which is the standard of care treatment (SOC) for patients with overt HE, was not significantly different between the rifaximin-treated and the naïve group.
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Notes to Editors:
About the study
The study examined the outcomes of patients listed for liver transplantation with a diagnosis of hepatic encephalopathy (HE) on rifaximin compared to those naïve to the drug. Real world data from patient records of those listed for liver transplantation over a 2-year period were retrospectively reviewed. Patients were included if they had at least two episodes of overt HE resulting in hospitalisation or were encephalopathic at the time of assessment. Of the 622 patients listed for transplantation, 101 were listed with HE. 66 patients were treated with rifaximin and 35 were naïve at listing. The use of concurrent lactulose was not significantly different between groups. Median MELD score was similar [15 (14-16) rifaximin-treated and 16 (14-18) rifaximin-naive]. Patients on the waiting list treated with rifaximin had reduced all-cause hospital admissions, episodes of spontaneous bacterial peritonitis and variceal bleeding. Mean length of stay was 9 (95%CI 6-12) in the rifaximin-treated group versus 14 days (95%CI 7-21) in the rifaximin-naïve group. Multivariate regression analysis demonstrated that rifaximin was independently associated with an increase in average days to readmission (adjusted effect estimate 71, 95% CI 3-140 days) and reduced likelihood of requirement for prioritisation on the waiting list (odds ratio 0.29; 95% CI 0.89-0.93). The study concluded that rifaximin prescribed for HE in patients listed for liver transplantation improved outcomes on the waiting list with a significant reduction in admissions related to spontaneous bacterial peritonitis, ascites and variceal bleeding.
About Hepatic Encephalopathy (HE)
HE is a serious, potentially life-threatening chronic condition associated with liver cirrhosis. HE is a significant complication of advanced chronic liver disease and occurs in up to 40% of patients and often remains under-diagnosed and under-treated., HE is debilitating and can significantly impact the life of patients and their carers. People with liver disease who develop HE are approximately twice as likely to die, when compared with liver disease patients without the condition over the same time period.
Hepatic encephalopathy results from a damaged liver that is not able to detoxify the blood as efficiently as usual. Toxins build up in the bloodstream and eventually in the brain, which leads to neurological disorders.
Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. Norgine specialises in gastroenterology, hepatology, cancer and supportive care. In 2018, Norgine's total net product sales were EUR 395 million, up 15 per cent.
Norgine employs over 1,300 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
In 2012, Norgine established a complementary business, Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com
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Alfasigma is a multinational pharmaceutical company headquartered in Italy, employing more than 2,800 people worldwide. In 2018, revenues exceeded €1,05 billion.
Outside of its core Italian market, Alfasigma has 17 subsidiaries in Europe, Asia, North and Central America and Africa, and has authorised distributors in more than 70 countries. Approximately half of the turnover comes from internally developed proprietary products, one of which is rifaximin.
For more information, please visit www.alfasigma.com
- Salehi S, Tranah TH, Lim S, et al. Rifaximin reduces the incidence of spontaneous bacterial peritonitis, variceal bleeding and all‐cause admissions in patients on the liver transplant waiting list. Aliment Pharmacol Ther. 2019;00:1–7. https://doi.org/10.1111/apt.15326 [Last accessed: June 2019]
- Morgan M. Chapter 8: Hepatic Encephalopathy in Patients with Cirrhosis. In: Dooley JS, Lok A, Burroughs A, Heathcote J, editors. Sherlock's Diseases of the Liver and Biliary System. 12th ed: Blackwell Publishing Ltd; 2011
- Hepatic Encephalopathy in Chronic Liver Disease: 2014 Practice Guideline by the European Association for the Study of the Liver and the American Association for the Study of Liver Diseases. Journal of Hepatology 2014; 61(3):642-659
- Mullen KD. Review of the final report of the 1998 Working Party on definition, nomenclature and diagnosis of hepatic encephalopathy. Aliment Pharmacol Ther. 2007 Feb; 25 Suppl 1:11-6
- Morgan, C.LI et al, Mortality associated with hepatic encephalopathy in patients with severe liver disease, Journal of Hepatology 2014; 60 (Abstract P452): S219
GL/COR/0519/0189, Date of preparation June 2019