STAINES-UPON-THAMES, United
Kingdom, April 15, 2019
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a leading global specialty pharmaceutical
company, is reporting data from a retrospective analysis of data
from the Phase 3 REVERSE trial to estimate the impact of applying
the revised International Club of Ascites (ICA) diagnostic criteria
for Hepatorenal Syndrome Type 1 (HRS-1) on timing of treatment and
serum creatinine (SCr) at treatment start. The data were shared on
April 13 at the 2019
International Liver Congress™ of the European Association for the
Study of the Liver (EASL) in Vienna,
Austria.
HRS-1 is a rare and acute disease characterized by the
development of rapid kidney failure in patients with advanced
chronic liver disease.[1] Prior to 2015, the traditional
definition of HRS-1 was a twofold increase of SCr to a level
greater than 2.5 mg/dL during a period of less than two weeks. In
2015, the ICA revised consensus recommendations for the diagnosis
of HRS-1 based on a dynamic change in SCr in patients with
cirrhosis, in order to support earlier treatment of HRS-1.
"HRS-1 has an extremely poor prognosis if left untreated and
patients often do not live beyond a few weeks after diagnosis,"
said Florence Wong, M.D.,
Professor, GI Division, Department of Medicine, University of Toronto, Toronto General Hospital. "This analysis is
important because serum creatinine level has been shown to be a
predictor of HRS reversal and potentially improved outcomes.
Therefore, it is imperative that time to treatment be as short as
possible after diagnosis before progression of HRS, i.e., a higher
pre-treatment serum creatinine level."
The poster, "The Diagnosis of Hepatorenal Syndrome (HRS): How
Much Does Use of the 2015 Revised Consensus Recommendations Affect
Earlier Treatment and Serum Creatinine (SCr) at Treatment
Start?" [Poster #SAT-141] can be accessed here.
The study is a retrospective analysis of pre-enrollment serial
SCr data from 141 of the 196 patients enrolled in the REVERSE trial
for which data were available for this analysis. Researchers
assessed the mean number of days between diagnosing HRS-1 using the
revised and the traditional criteria. SCr at diagnosis was compared
using the revised and the traditional criteria to estimate the
effect of the revised criteria on SCr at the potential start of
vasoconstrictor therapy.
Study Highlights:
- Applying revised ICA Acute Kidney Injury-HRS diagnostic
criteria rather than traditional HRS-1 diagnostic criteria would be
estimated to result in:
-
- Earlier treatment by approximately four days
- SCr level at initiation of treatment would be on average
approximately 1 mg/dL lower
- Almost half (47 percent) of patients would receive
treatment before a further ≥ 1.5-fold increase in SCr
The retrospective study was supported by Mallinckrodt.
Study Limitations:
This study is a retrospective analysis of a previously completed
clinical trial. Results were based on a statistical model that was
not specified or measured in the original clinical trial. Results
do not imply cause and effect and may be incomplete.
"HRS-1 is a diagnosis of exclusion; initiating treatment takes
time. This analysis underscores the need for urgency in utilizing
the newer diagnostic criteria in facilitating earlier treatment for
HRS-1 patients in order to facilitate potentially better outcomes
for patients," said Tunde
Otulana, M.D., Senior Vice President and Chief Medical
Officer at Mallinckrodt. "We are committed to supporting
best practices for patients with HRS-1, including diagnostic
criteria that can potentially improve the treatment paradigm."
About Hepatorenal Syndrome Type 1
Hepatorenal Syndrome
Type 1 (HRS-1) is a rare and acute disease characterized by the
development of rapid kidney failure in patients with advanced
chronic liver disease.1 HRS-1 has a very poor
prognosis, with a median survival time of less than two weeks and
greater than 80 percent mortality within three
months.[2],[3] At present, there are no approved
drug therapies for HRS-1 treatment in the U.S.
or Canada.[4]
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; and analgesics. Its Specialty Generics and Amitiza
reportable segment includes specialty generic drugs, active
pharmaceutical ingredients and
AMITIZA® (lubiprostone). To learn more about
Mallinckrodt, visit
www.mallinckrodt.com.
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
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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 the study described in this release, including the
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
For Trade Media
Inquiries
Caren Begun
Green Room Communications
201-396-8551
caren@greenroompr.com
For Financial/Dailies Media Inquiries
Daniel Yunger
Kekst CNC
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@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.
© 2019 Mallinckrodt. US-1900479 4/19
References
1 National Organization for Rare Disorders.
Hepatorenal Syndrome. Available at:
https://rarediseases.org/rare-diseases/hepatorenal-syndrome/.
Accessed October 29, 2018.
2 Colle 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.
3 Gines P, Sola E, Angeli P, et al. Hepatorenal
syndrome. Nature Reviews. (2018) 4:23.
4 Boyer 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.
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SOURCE Mallinckrodt plc