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Norgine: New Real World Study Shows Rifaximin-a Significantly Reduced Hospitalisation in Patients With Overt Hepatic Encephalopathy (HE) When Added to Lactulose.

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The findings, borne out in real world evidence, come from an independent, investigator initiated study, presented today at the International Liver Congress (ILC) in Vienna. The study compared the progress of 127 patients in their first six months of combination treatment with rifaximin-a with the prior six months when treated with lactulose alone.[1] 

"Adding rifaximin-a to standard treatment was proven to significantly reduce episodes of hepatic encephalopathy in liver disease patients and keep patients out of hospital for longer, compared to lactulose alone" said Dr. Rosalie C. Oey, Lead Investigator of the study. "Preventing the recurrence of HE is extremely important for patients' quality of life and the findings highlight the prophylactic value of rifaximin-a in the long-term management of the disease."

Marko Korenjak, President, European Liver Patients' Assosiation (ELPA) commented, "Hepatic encephalopathy is a very serious and frightening complication for both patients and their carers and significantly impacts on people's quality of life. The European Liver Patients' Assosiation welcomes research that may enhance the availability of treatment options which potentially benefit patients and reduce the burden on healthcare systems."

HE is a serious, potentially life-threatening chronic condition associated with liver cirrhosis.[2] 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.[3],[4] 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. [5]  

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Notes to Editors:

About the study

The study aimed to evaluate the efficacy and safety of rifaximin treatment in a real-world pattern, five years after rifaximin-α registration as secondary prophylaxis for overt hepatic encephalopathy (HE) in the Netherlands. The study included 127 patients (71.7% male; median age 60.8 years (IQR 56.2-66.1); median MELD score 15.0 (IQR 12.1-20.4)). When comparing the first 6 months after rifaximin-α initiation to the prior 6 months, HE-related hospital admissions reduced (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). Non-serious adverse events were recorded in 2.4% of patients. The investigated-initiated study was sponsored by the Foundation for Liver and Gastrointestinal Research Rotterdam (SLO) and supported by an educational grant from Norgine B.V., Amsterdam, the Netherlands.

About Hepatic Encephalopathy (HE)

HE is a serious and potentially life-threatening neuropsychiatric condition associated with liver cirrhosis.[2] Severe HE has been estimated to affect 40% of people with cirrhosis and symptoms include disorientation, confusion, inappropriate behaviour and personality change.[3] 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.[3]

About Norgine

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 2017, Norgine's total net product sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 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

NORGINE and the sail logo are trademarks of the Norgine group of companies.

References

[1] Oey, R.C. et al,  The efficacy and safety of rifaximin-α: a 2-year observational study of overt hepatic encephalopathy, Presented at , International Liver Congress (ILC) 2019, Vienna SAT-092  

[2] 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

[3] 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

[4] 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

[5] Morgan, C.LI et al, Mortality associated with hepatic encephalopathy in patients with severe liver disease, Hepatology 2014; 60 (Abstract P452): S219

GL/COR/0419/0188, Date of preparation April 2019

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