Norgine Presents PROSPER Study - First Ever Real World Evidence Study in Hepatic Encephalopathy Patients Taking rifaximin- α 550mg

LONDON, April 22, 2015 /PRNewswire/ --

Norgine B.V. today presented the study design of PROSPER, a real world outcomes study of hepatic encephalopathy patients' experiences on rifaximin-α 550mg at the International Liver Congress (ILC) 2015. PROSPER is an observational, multicentre study among 550 patients in Europe and Australia. It has been designed to monitor the clinical effectiveness of rifaximin-α and its impact on health care resources utilisations.^[1]

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Hepatic encephalopathy places a significant burden on patients and their caregivers, with the burden increasing as the severity of the disease progresses.^[2],[3] Furthermore patients with hepatic encephalopathy have significantly more hospitalisations, emergency hospital admissions, and primary care contacts compared with patients with severe liver disease without hepatic encephalopathy.^[4]

It is anticipated that the findings of this study will provide important real world evidence, as well as potentially providing a better understanding of the burden and natural history of hepatic encephalopathy as well as the variability in disease management in individual units.

Donna McVey, Chief Development Officer, Norgine said: "The announcement of this study is a milestone in our journey in hepatology and demonstrates our commitment to patients with hepatic encephalopathy; helping to improve the understanding of the impact of rifaximin-α 550mg in the real world, beyond what we see in controlled clinical trials. This study will help us and healthcare decision-makers to improve the treatment of hepatic encephalopathy and ensure effective use of rifaximin-α 550mg to minimise the burden of this disease on patients, their carer and healthcare budgets."

Hepatic encephalopathy is a serious and potentially life-threatening neuropsychiatric condition associated with advanced liver cirrhosis that affects around 248,000 people in Europe and Australia combined.^{[5],[6],[7],[8]}

Full release on http://www.norgine.com

1. Prospective real world outcomes study of HE patients' experience on rifaximin- (PROSPER): an observational study among 550 patients. Abstract CT-4256. International Liver Congress 2015

2. Bajaj JS, et al. Am J Gastroenterol 2011; 106(9): 1646-1653.

3. Montagnese S, et al. Metab Brain Dis 2012; 27: 567-572.

4. Orr J, et al. J Hepatol 2014; 60:S215-359 Abstract 478.

5. Blachier M et al. The Burden of Liver Disease in Europe European Association for the Study of the Liver 2013;0: 1-64

6. Eurostat. World population, 1960-2012

7. Poordad FF. Review article: the burden of hepatic encephalopathy Aliment Pharmacol Ther 2007;25 (suppl. 1): 3-9

8. The economic cost and health burden of liver disease in Australia. The Gastroenterological Society of Australia/Australian Liver Association. January 2013