Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics
Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics - U.K. medical chart study showed an association between patients treated with terlipressin and an improvement in kidney function in 73 percent of hospitalized adult patients with HRS-1 - |
[11-June-2020] |
STAINES-UPON-THAMES, United Kingdom, June 11, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.1 The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr). The results of the study were published in the peer-reviewed journal Alimentary Pharmacology and Therapeutics. Mallinckrodt is investigating terlipressin for the treatment of HRS-1 in the U.S. Its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration (FDA). Medical records of 250 adult patients with HRS-1 from 26 centers in the U.K. were reviewed, 225 of whom were treated with vasopressor therapy. The majority of patients were treated with terlipressin (n=203, 90 percent) with a median duration of therapy of six days, in line with European Association for the Study of the Liver (EASL) guidelines recommending terlipressin for first-line use in patients with HRS-1.2 A complete response (SCr reduction of ≤1.5 mg/dL) was observed in 50 percent of patients treated with terlipressin and 23 percent of those treated with other vasopressors. Overall response, as measured by a complete response or partial response (SCr reduction of at least 20 percent from baseline but SCr >1.5 mg/dL), was demonstrated in 73 percent of patients treated with terlipressin and 59 percent treated with other vasopressors. In addition, lower SCr at the time of treatment initiation was associated with higher complete response rates.3 "While there are limitations to medical chart study, the findings from this real-world data are encouraging for patients with HRS-1 who have limited treatment options and are often facing a poor prognosis," said lead author Kevin Moore, M.D., UCL Institute of Liver and Digestive Health, Royal Free Hospital, University College London. HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated.4,5 At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada.6 HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually.7,8 The company announced in April the U.S. FDA accepted its New Drug Application for review of terlipressin to treat HRS-1. "This retrospective analysis of the use of terlipressin in HRS-1 patients, where it is approved and available, provides important insight into the real-world treatment patterns and outcomes in this rare, acute syndrome," said Tunde Otulana, M.D., Senior Vice President and Chief Medical Officer at Mallinckrodt. "Mallinckrodt is committed to advancing the science to benefit patients with this devastating and rapidly progressing syndrome for which effective treatment options are limited." About the Study3
About Terlipressin Mallinckrodt uses its website as a channel of distribution of important company information, such as press releases, investor presentations and other financial information. It also uses its website to expedite public access to time-critical information regarding the company in advance of or in lieu of distributing a press release or a filing with the U.S. Securities and Exchange Commission (SEC) disclosing the same information. Therefore, investors should look to the Investor Relations page of the website for important and time-critical information. Visitors to the website can also register to receive automatic e-mail and other notifications alerting them when new information is made available on the Investor Relations page of the website. CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS CONTACTS For Financial/Dailies Media Inquiries Investor Relations References 1National Organization for Rare Disorders. Hepatorenal Syndrome. Available at: https://rarediseases.org/rare-diseases/hepatorenal-syndrome/. Accessed June 4, 2020. 2European Association for the Study of the Liver. EASL clinical practice guidelines for the management of patients with decompensated cirrhosis. J Hepatol. 2018;69:406-460. 3Moore K, Jamil K, Verleger K, Luo L, Kebede N, Heisen M, et al. Real–world treatment patterns and outcomes using terlipressin in 203 patients with the hepatorenal syndrome. Aliment Pharmacol Ther. 2020;00:1-8. DOI: 10.111/apt.15836. 4Colle I and Laterre PF. Hepatorenal syndrome: the clinical impact of vasoactive therapy. Expert Review of Gastroenterology & Hepatology. 2018;12:2:173-188. DOI: 10.1080/17474124.2018.1417034. 5Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018; 4:23. 6Boyer TD, Medicis JJ, Pappas SC, et al. A randomized, placebo-controlled, double-blind study to confirm the reversal of hepatorenal syndrome type 1 with terlipressin: the REVERSE trial design. Open Access Journal of Clinical Trials. 2012:4. https://www.dovepress.com/a-randomized-placebo-controlled-double-blind-study-to-confirm-the-reve-peer-reviewed-article-OAJCT. 7C Pant, B S Jani, M Desai, A Deshpande, Prashant Pandya, Ryan Taylor, R Gilroy, M Olyaee. Hepatorenal syndrome in hospitalized patients with chronic liver disease: results from the Nationwide Inpatient Sample 2002–2012. J Investig Med. 2016;64:33–38. 8United States Census Bureau: Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/PST045218. Accessed June 4, 2020. View original content to download multimedia:http://www.prnewswire.com/news-releases/real-world-data-of-terlipressin-in-hospitalized-patients-in-uk-with-hepatorenal-syndrome-type-1-hrs-1-published-in-alimentary-pharmacology-and-therapeutics-301074172.html SOURCE Mallinckrodt Pharmaceuticals | ||
Company Codes: NYSE:MNK |
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