New Study Shows Rifaximin Significantly Reduced the Number and Length of Hospitalisations in Patients With Overt Hepatic Encephalopathy (HE) Awaiting Liver Transplatation

Amsterdam (ots/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).[1]

Therealworldstudypublishedtodayinthepeer-reviewedjournalAlimentaryPharmacologyandTherapeuticsshowedthatrifaximin,whenprescribedforthetreatmentofacuteorchronicHE,orforsecondarypreventionofHEinpatientswithadvancedcirrhosiswhoareonthewaitinglistforlivertransplantation,significantlyreducedtheincidenceofall-causehospitaladmissions(meanlengthofstay:9days;95%CI6-12inrifaximin-treatedpatientsvs.14days;95%CI7-21inthenaïvegroup).Thisincludedseriousmedicalcomplicationssuchasspontaneousbacterialperitonitis(anacuteinfectionintheabdomenthatoccurswithoutwarningoraclearcause),ascites(anabnormalbuild-upoffluidintheabdomenthatcancauseinfection)andvaricealbleeding(dilatedbloodvesselsintheoesophagusorstomachthatcancauseinternalbleeding).Onaverage,HEpatientsonthetransplantwaitinglistwhodidnotreceiverifaximintendedtostay5dayslongerinhospitalwhenadmittedduetocomplications.[1]

Patientsonrifaximinalsoavoidedre-hospitalisationforlongerandwerelesslikelytorequireurgentlivertransplantationduetodeteriorationoftheircondition(oddsratio0.29;95%CI0.89-0.93).[1]

"End-stageliverdiseasepatientsalreadyhaveapoorprognosisandlowqualityoflife;hepaticencephalopathyisafurtherdevastatingcomplication.Thisstudydemonstratesthepotentialvalueofrifaximinforthosevulnerablepatientsanditsimpactonimprovingoutcomesandreducingtheneedforhospitalisation,"saidDr.DebbieShawcross,LeadInvestigatorofthestudy,ReaderandHonoraryConsultantinHepatologyattheDepartmentofLiverSciences,King'sCollegeLondon.

Thestudyevaluatedfortwoyears101patientswhohadatleasttwoepisodesofovertHEwhilsttheywerewaitingforalivertransplant.Theuseoflactulose,whichisthestandardofcaretreatment(SOC)forpatientswithovertHE,wasnotsignificantlydifferentbetweentherifaximin-treatedandthenaïvegroup.[1]

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Aboutthestudy

Thestudyexaminedtheoutcomesofpatientslistedforlivertransplantationwithadiagnosisofhepaticencephalopathy(HE)onrifaximincomparedtothosenaïvetothedrug.Realworlddatafrompatientrecordsofthoselistedforlivertransplantationovera2-yearperiodwereretrospectivelyreviewed.PatientswereincludediftheyhadatleasttwoepisodesofovertHEresultinginhospitalisationorwereencephalopathicatthetimeofassessment.Ofthe622patientslistedfortransplantation,101werelistedwithHE.66patientsweretreatedwithrifaximinand35werenaïveatlisting.Theuseofconcurrentlactulosewasnotsignificantlydifferentbetweengroups.MedianMELDscorewassimilar[15(14-16)rifaximin-treatedand16(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.[1]

About Hepatic Encephalopathy (HE)

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]

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 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

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

About Alfasigma

Alfasigma is a multinational pharmaceutical company headquartered in Italy, employing more than 2,800 people worldwide. In 2018, revenues exceeded EUR1,05 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

References

  1. 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]
  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, Journal of Hepatology 2014; 60 (Abstract P452): S219

GL/COR/0519/0189, Date of preparation June 2019

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