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Mallinckrodt
Presents Results on Real World Treatment Patterns and Outcomes in Hospitalized Patients with
Esophageal Variceal Hemorrhage
and
Liver Cirrhosis
Treated with
Terlipressin
at the ACG Annual Scientific Meeting
2021-10-25
·
BioSpace
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免疫疗法
U.K., multicenter, retrospective medical chart review study showed
terlipressin
is commonly prescribed for
esophageal variceal hemorrhage (EVH)
in real world clinical practice DUBLIN, Oct. 25, 2021 /PRNewswire/ --
Mallinckrodt plc
, (OTCMKTS: MNKKQ) a global biopharmaceutical company, today announced results from a retrospective medical chart review study examining treatment patterns and outcomes in hospitalized patients with
esophageal variceal hemorrhage (EVH)
and
liver cirrhosis
treated with
terlipressin
. EVH is a major complication of
cirrhosis
and a leading cause of death in people with cirrhosis.1 Results were presented at the
American College of Gastroenterology
Annual Scientific Meeting being held virtually and live in Las Vegas from October 22-27. The poster can be accessed here on the company's website.
Terlipressin
is an investigational product and its safety and effectiveness have not yet been established by the U.S. Food and Drug Administration. The retrospective medical chart review study assessed real world outcomes in 195 hospitalized adult patients across 18 hospitals in the U.K. (where
terlipressin
is approved and available) from January 1, 2016, through September 30, 2019. To be eligible for the analysis, patients had to be at least 18 years of age at hospital admission, be admitted within 24-36 hours after occurrence of EVH, had a history of
liver cirrhosis
, complete hospital information from admission to discharge and no prior history of EVH in three months. Data were collected from hospital admission up to 90 days post-discharge or until death using an electronic case report form. Nearly all patients (n=192; 98.5 percent) in the analysis were treated with
terlipressin
within a day of hospital admission and the mean treatment duration was 4.3 days. The primary clinical outcome was control of
bleeding
within 36 hours and five days defined per Baveno V criteria, which define treatment failure as death or fresh
hematemesis
or nasogastric aspiration of ≥100 mL of fresh blood ≥two hours after the start of a specific drug treatment or therapeutic endoscopy, 3-g drop in hemoglobin within any 24-hour period if no transfusion is administered, and hypovolemic shock.2,3 The study found that, based on Baveno V criteria, 116 patients (59.5 percent) achieved an initial bleed control within 36 hours and 111 patients (56.9 percent) within five days. Of the patients who had an initial bleed control in 36 hours, rebleeding was observed in 47 patients (40.5 percent) within three days, 50 patients (43.1 percent) within five days and 53 patients (45.7 percent) within seven days. Of the patients who had an initial bleed control in five days, rebleeding was observed in 46 patients (41.4 percent) within three days, 48 patients (43.2 percent) within five days and 48 patients (43.2 percent) within seven days of the initial bleed control. The study had limitations inherent to the retrospective nature of the study design, and data collected was limited to the information available and extracted from patient medical charts. "It is critically important to expand our knowledge of evidence-based medicine for EVH, and investigational therapies like
terlipressin
, so that we can strive to address health outcomes for patients," said Kevin Moore, M.D., Ph.D., lead investigator and principal clinical research fellow at the
UCL Institute
of Liver and Digestive Health, Royal Free Hospital,
University College London
.
Terlipressin
has previously been studied and approved by the National Health Service in the U.K. in this patient population, and scientific evidence of the published study was summarized in a Cochrane review.4
Terlipressin
is one of the accepted vasoactive therapies recommended by the European Association for the Study of the Liver guidelines, which recommends that vasoconstrictive therapy should be initiated as soon as
acute variceal bleeding
is suspected and before endoscopy.5 "Mallinckrodt is committed to understanding
terlipressin
's potential for patients suffering from complications of
cirrhosis
and continuing to build on the existing scientific research of
terlipressin
for the treatment of these complications6," said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. This study was sponsored by Mallinckrodt. About
Esophageal Variceal Hemorrhage
(EVH)
Esophageal varices
are abnormal dilations of veins in the lower part of the esophagus that may develop in patients with
chronic liver damage
, or
cirrhosis.4
Bleeding
, or
hemorrhage
from these varices, is a life-threatening complication and is a leading cause of death in people with
cirrhosis.1,4
About
Terlipressin
Terlipressin
is a potent vasopressin analogue selective for V1 receptors. It is an investigational product in the U.S. and Canada as the safety and efficacy have not been established with, nor has approval been granted by, regulatory authorities in either country.
Terlipressin
is approved for use outside the U.S. and Canada. ABOUT MALLINCKRODT
Mallinckrodt
is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about
Mallinckrodt
, visit .
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 This release includes forward-looking statements with regard to
terlipressin
, including its potential impact on patients. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; issues with product quality, manufacturing or supply, or patient safety issues; and other risks identified and described in more detail in the "Risk Factors" section of
Mallinckrodt
's most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Tara DiFlumeri Senior Vice President, Green Room Communications 908-577-4531 tara@greenroompr.com Investor Relations Daniel J. Speciale Vice President, Finance and Investor Relations Officer 314-654-3638 daniel.speciale@mnk.com Government Affairs Derek Naten Vice President, Government Affairs & Patient Advocacy derek.naten@mnk.com
Mallinckrodt
, the "M" brand mark and the
Mallinckrodt Pharmaceuticals
logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a
Mallinckrodt company
or their respective owners. © 2021 Mallinckrodt. US-2100805 10/21 References 1 Seo YS, et al. Lack of difference among
terlipressin
,
somatostatin
and
octreotide
in the control of
acute gastroesophageal varicel hemorrhage
. Hepatology. 2014;60(3):954-963. 2 Ahn SY, Park SY, Tak WY, et al. Prospective validation of Baveno V definitions and criteria for failure to control bleeding in
portal hypertension
. Hepatology. 2015;61(3):1033-1040. 3 de Franchis R, Baveno VF. Revising consensus in
portal hypertension
: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in
portal hypertension
. J Hepatol. 2010;53(4):762-768 4 Ioannou G, Doust J, Rockey DC.
Terlipressin
for acute esophageal variceal hemorrhage. Cochrane Database Syst Rev. 2003(1):CD002147. 5 The European Association for the Study of the Liver. EASL Clinical Practice Guidelines for the management of patients with
decompensated cirrhosis
. J Hepatol (2018). . 6 National Organization for Rare Disorders.
Hepatorenal Syndrome
. Available at: . Accessed October 18, 2021. View original content to download multimedia:
SOURCE Mallinckrodt plc Company
Codes: OTC-BB:MNKKQ, OTC-PINK:MNKKQ
机构
American College of Gastroenterology
University College London
Mallinckrodt Pharmaceuticals Ltd.
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