Real-World Data of Terlipressin in Hospitalized Patients in U.K. with Hepatorenal Syndrome Type 1 (HRS-1) Published in Alimentary Pharmacology and Therapeutics
Mallinckrodt is investigating terlipressin for the treatment of HRS-1 in the
Medical records of 250 adult patients with HRS-1 from 26 centers in the
"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
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
"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
About the Study3
The study, titled Real-World Treatment Patterns and Outcomes Using Terlipressin in 203 Patients with the Hepatorenal Syndrome, was a medical chart study to assess treatment and outcomes of terlipressin and other vasopressors in 250 adult patients with HRS-1 hospitalized in 26 centers in the
- Terlipressin was associated with improved kidney function: the overall response rate was 73 percent and the complete response rate (SCr <1.5 mg/dL) was 50 percent of patients treated with terlipressin.
- Lower SCr at the time of treatment initiation was associated with higher complete response rates. Mild, moderate and severe acute kidney injury (AKI) were defined by baseline SCr:
- Mild AKI (SCr <2.25 mg/dL): 79 percent complete response.
- Moderate AKI (SCr ≥2.25 mg/dL and <3.5 mg/dL): 55 percent complete response.
- Severe AKI (SCr ≥3.5 mg/dL): 14 percent complete response.
- The 90-day survival was 86 percent for all patients (93 percent for overall responders and 66 percent for treatment non-responders, P<0.0001).
- Adverse events were attributed to terlipressin in 25 percent of patients and 41 percent in those treated with other vasopressors.
- Fluid overload/pulmonary edema and multi-organ failure were the most commonly reported adverse events. Severe AKI was associated with higher rates of adverse events (41 percent severe AKI versus 25 percent moderate AKI versus 9 percent mild AKI, P<0.001).
- Study Limitations:
- Patients in the retrospective chart study likely represented a more heterogeneous population than that included in randomized controlled trials of HRS-1 patients.
- All patients may not have met the full criteria for HRS-1 diagnosis, as diagnosis relies on clinical judgement rather than an objective diagnostic test.
- Robustness of between treatment difference is uncertain due to lack of randomization and small number of patients on other vasopressors.
- Changes to the 2015
International Club of Ascites Hepatorenal Syndrome(ICA-HRS) guidelines, which occurred during the study, may have altered clinicians' judgement on when to initiate treatment.
- The study's sampling strategy may have led to higher survival and treatment response rates than seen in other settings, leading to a selection bias towards surviving patients.
Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the
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CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements with regard to terlipressin and the study described in this release, 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.
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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.
7C Pant, B S Jani, M Desai, A Deshpande,
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