Mallinckrodt Showcases TERLIVAZ Research at AASLD Annual Meeting
Mallinckrodt to Present Data on TERLIVAZ® for Injection
Four impactful posters will shed light on the research data surrounding TERLIVAZ (terlipressin) at the upcoming annual meeting of the American Association for the Study of Liver Diseases (AASLD). This event is an opportunity for Mallinckrodt to showcase its findings on the application of TERLIVAZ for adults suffering from hepatorenal syndrome (HRS) with rapid kidney function decline.
Understanding Hepatorenal Syndrome
Hepatorenal syndrome, particularly the variant that causes quick deterioration of kidney function, presents as an acute, critical condition that often necessitates hospitalization. Each year, it is estimated that over 42,000 individuals in the U.S. encounter this rare syndrome, representing about 0.01% of the population. The urgency of addressing this condition is heightened by rising hospitalization rates due to HRS.
Research Discoveries on TERLIVAZ
Mallinckrodt's dedicated analysis is evident in three primary poster presentations from their Phase 3 placebo-controlled studies. These studies focus on various aspects, such as:
- An exploration into the effects of delaying treatment until Day 4 or after the twelfth dose before assessing reversal of HRS.
- Investigating how obesity impacts response to TERLIVAZ, as indicated by body mass index (BMI) measurements.
- Comparative outcomes of HRS reversal between patients on standard doses versus those receiving higher doses of terlipressin.
Key Research Outcomes and Investigators
The findings will be presented by leading experts, emphasizing the importance of this research in understanding subpopulations of HRS patients. Peter Richardson, MRCP (UK), Executive Vice President and Chief Scientific Officer of Mallinckrodt, highlighted the significance of these data presentations in enhancing clinical knowledge and treatment outcome insights. Poster presentations will detail:
Poster #4094: Treatment Response Evaluation
- Presenter: Manhal J. Izzy
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Date & Time: Monday, 8:00 a.m. – 5:00 p.m. PT
This study assesses waiting for four days after initiating treatment with terlipressin to evaluate its effectiveness in reversing HRS.
Poster #4095: Obesity's Role in Treatment Response
- Presenter: Kavish R. Patidar
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Date & Time: Monday, 8:00 a.m. – 5:00 p.m. PT
This research retrospectively evaluates how BMI affects the reversal of HRS in patients treated with TERLIVAZ.
Poster #4096: Dose Comparison Analysis
- Presenter: Pratima Sharma
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Date & Time: Monday, 8:00 a.m. – 5:00 p.m. PT
The focus here is on understanding the efficacy and safety differences between standard and high doses of terlipressin.
Poster #4092: Impact on Liver Transplant Rates
- Presenter: Pierre M. Gholam
- Session Title: Portal Hypertension and Other Complications of Cirrhosis
- Date & Time: Monday, 8:00 a.m. – 5:00 p.m. PT
This analysis looks at the effectiveness of TERLIVAZ treatment related to liver transplantation rates in patients with HRS.
Safety Considerations for TERLIVAZ
While emphasizing the potential benefits of terlipressin, it is crucial to remain aware of the safety information and limitations associated with its use. The use of TERLIVAZ is contraindicated in patients experiencing respiratory distress or significant cardiovascular issues. Continuous monitoring is necessary to mitigate risks related to oxygen saturation and overall patient health.
About Mallinckrodt and Its Innovations
Mallinckrodt is a pioneering global company dedicated to developing and distributing specialty pharmaceutical products. With a robust focus on various therapeutic areas, including neurology, rheumatology, hepatology, and oncology, Mallinckrodt seeks to make a significant impact in healthcare.
Frequently Asked Questions
What is TERLIVAZ?
TERLIVAZ (terlipressin) is a medication designed to improve kidney function in adults with hepatorenal syndrome.
What is hepatorenal syndrome (HRS)?
HRS is a serious condition that arises in individuals with advanced liver disease and features rapid kidney function decline.
What are the key findings from the presented data at AASLD?
The data includes insights on treatment timing, the impact of obesity, and dosing efficacy of TERLIVAZ.
Who are the presenters of the posters at AASLD?
The posters will be presented by experts including Manhal J. Izzy and Kavish R. Patidar, highlighting various aspects of TERLIVAZ treatment.
Is there any risk associated with TERLIVAZ?
Yes, there are safety warnings, including serious or fatal respiratory failure, and it is essential to monitor patients closely while they are on the medication.
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