TERLIVAZ is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) involving rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2
The findings from a pooled analysis across the OT-0401, REVERSE, and CONFIRM clinical trials, presented by Dr.
'We are eager to share data from our latest studies assessing treatment paradigms in the management of HRS and examining the clinical benefits of patients treated with terlipressin among the broader healthcare professional community. These findings provide critical insight into the importance of patient characteristics at baseline and reducing the time to therapeutic intervention in potentially improving long-term outcomes and the avoidance of renal replacement therapy, such as dialysis, in adults with HRS,' said
These studies are sponsored by
Abstract TH-PO034: Initiation of Terlipressin at Lower Serum Creatinine Levels Is Associated With Avoidance of Dialysis in Patients With Hepatorenal Syndrome Type 13
Presenter:
Presentation Date:
Location: Exhibit Hall,
Abstract TH-PO035: Impact of Terlipressin on Serum Sodium Levels in Patients with HRS - the North American Experience4
Presenter: Shehzad Nawaz Merwat, MD
Presentation Date:
Location: Exhibit Hall,
Abstract TH-PO037: Impact of HRS Reversal on the Need for Renal Replacement Therapy - Analysis from 3 Phase III Terlipressin Studies5
Presenter:
Presentation Date:
Location: Exhibit Hall,
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Terlipressin is one of the most studied pharmacological agents in HRS with more than 70 published manuscripts and presented abstracts on clinical data to date.6 It has been approved outside the
About Hepatorenal Syndrome (HRS)
Hepatorenal syndrome (HRS) involving rapid reduction in kidney function1 is an acute and life-threatening condition that occurs in people with advanced liver disease.2 HRS is classified into two distinct types - a rapidly progressive type that leads to acute renal failure where patients are typically hospitalized for their care and a more chronic type that progresses over weeks to months.2 HRS involving rapid reduction in kidney function1 is estimated to affect between 30,000 and 40,000 Americans annually.9,10 If left untreated, HRS with rapid reduction in kidney function1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months.11
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, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; cultured skin substitutes and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to TERLIVAZ, 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
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