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

Amsterdam (ots/PRNewswire) - Norgine B.V. today highlighted results of a real world study showing significant reductions in the number and length of hospitalisations when rifaximin-a is added to lactulose, the SOC treatment for patients with overt hepatic encephalopathy (HE).[1]

  • Rifaximin-aincombinationwithlactulose,thestandardofcare(SOC)treatmentresultedinsignificantreductions(p<0.001)inbothHErelatedhospitaladmissionsandlengthofhospitalstay
  • Rifaximin-aalsoshowedgoodefficacyinthemanagementofpatientswithliverdiseasewiththecomplicationofHEbasedonreal-worlddata
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Thefindings,borneoutinrealworldevidence,comefromanindependent,investigatorinitiatedstudy,presentedtodayattheInternationalLiverCongress(ILC)inVienna.Thestudycomparedtheprogressof127patientsintheirfirstsixmonthsofcombinationtreatmentwithrifaximin-awiththepriorsixmonthswhentreatedwithlactulosealone.[1]

"Addingrifaximin-atostandardtreatmentwasproventosignificantlyreduceepisodesofhepaticencephalopathyinliverdiseasepatientsandkeeppatientsoutofhospitalforlonger,comparedtolactulosealone"saidDr.RosalieC.Oey,LeadInvestigatorofthestudy."PreventingtherecurrenceofHEisextremelyimportantforpatients'qualityoflifeandthefindingshighlighttheprophylacticvalueofrifaximin-ainthelong-termmanagementofthedisease."

MarkoKorenjak,President,EuropeanLiverPatients'Assosiation(ELPA)commented,"Hepaticencephalopathyisaveryseriousandfrighteningcomplicationforbothpatientsandtheircarersandsignificantlyimpactsonpeople'squalityoflife.TheEuropeanLiverPatients'Assosiationwelcomesresearchthatmayenhancetheavailabilityoftreatmentoptionswhichpotentiallybenefitpatientsandreducetheburdenonhealthcaresystems."

HEisaserious,potentiallylife-threateningchronicconditionassociatedwithlivercirrhosis.[2]HEisasignificantcomplicationofadvancedchronicliverdiseaseandoccursinupto40%ofpatientsandoftenremainsunder-diagnosedandunder-treated.[3],[4]HEisdebilitatingandcansignificantlyimpactthelifeofpatientsandtheircarers.PeoplewithliverdiseasewhodevelopHEareapproximatelytwiceaslikelytodie,whencomparedwithliverdiseasepatientswithouttheconditionoverthesametimeperiod.[5]

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Aboutthestudy

Thestudyaimedtoevaluatetheefficacyandsafetyofrifaximintreatmentinareal-worldpattern,fiveyearsafterrifaximin-alpharegistrationassecondaryprophylaxisforoverthepaticencephalopathy(HE)intheNetherlands.Thestudyincluded127patients(71.7%male;medianage60.8years(IQR56.2-66.1);medianMELDscore15.0(IQR12.1-20.4)).Whencomparingthefirst6monthsafterrifaximin-alphainitiationtotheprior6months,HE-relatedhospitaladmissionsreduced(0.86to0.41admissions/patient;p<0.001),aswellasthemeanlengthofstay(8.85to3.79beddays/admission;p<0.001).Non-seriousadverseeventswererecordedin2.4%ofpatients.Theinvestigated-initiatedstudywassponsoredbytheFoundationforLiverandGastrointestinalResearchRotterdam(SLO)andsupportedbyaneducationalgrantfromNorgineB.V.,Amsterdam,theNetherlands.

AboutHepaticEncephalopathy(HE)

HEisaseriousandpotentiallylife-threateningneuropsychiatricconditionassociatedwithlivercirrhosis.[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 www.norgineventures.com

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-alpha: 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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