Terlipressin is an investigational product and its safety and effectiveness have not yet been established by the
"The work of
The first poster presentation titled "Hepatorenal Syndrome Patient Characteristics, Treatment, and Clinical Response by Disease Severity: Real-world Practice Patterns from 11 U.S. Hospitals," is a retrospective, observational study based on medical chart data from 132 hospitalized adult patients across 11 hospitals in the
A total of 65 patients (49.2 percent) had standard disease severity and 67 (50.8 percent) had severe disease. The analysis showed that initial use of vasopressor therapies was similar between the two groups with midodrine/octreotide monotherapy being the most widely used (89.2 percent in standard cases versus 82.1 percent in severe cases). Overall response to therapy (N=132) was low in patients initiating existing treatment regimens irrespective of disease severity (Complete Response: 13.8 percent versus 17.9 percent and Partial Response: 9.2 percent versus 16.4 percent in the standard and severe groups, respectively, p=0.324).2
The limitations of this post hoc analysis of a retrospective chart review may include a more heterogeneous HRS population than those in randomized clinical trials, sampling bias from conveniently selected centers, potential selection bias towards patients with known outcomes to the providers and under reporting of less severe adverse events.
"Hepatorenal syndrome is very difficult to diagnose and typically met with high mortality rates if left untreated.3,4 Our analysis showed that overall response rate was low in patients initiating existing treatment regimens irrespective of disease severity, indicating a high unmet medical need in people with HRS-1, and need for alternate therapies," said
The second poster presentation, titled "Serum Creatinine ≥5 mg/dL is Associated with Decreased Safety and Efficacy in Patients Treated with Terlipressin for Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) in the
The results showed that among 203 patients who received terlipressin, 181 (89 percent) had a SCr <5 mg/dL at presentation and 22 (11 percent) had a SCr ≥5 mg/dL. The overall response rate was 74.0 percent in patients with presenting SCr <5 mg/dL and 63.6 percent in patients with presenting SCr ≥5 mg/dL. Patients with a presenting SCr <5 mg/dL were more likely to achieve complete response compared with those with presenting SCr ≥5 mg/dL (54.7 versus 13.6 percent, respectively; P<.001). The overall survival was longer in patients with presenting SCr <5 mg/dL than in patients with presenting SCr ≥5 mg/dL (P =.041). Additionally, patients with presenting SCr ≥5 mg/dL were more likely to develop fluid overload or pulmonary edema (27.3 percent) and multi-organ failure (31.8 percent) compared to patients with a SCr <5 mg/dL (14.4 and 6.1 percent, respectively).5
The limitations of this post hoc analysis of a retrospective chart review may include a more heterogeneous HRS population than those in randomized clinical trials, sampling bias from conveniently selected centers, potential selection bias towards patients with known outcomes to the providers and under reporting of less severe adverse events.
"Our analysis supports previous studies linking higher presenting SCr to poorer outcomes in patients with HRS-1.6,7 Importantly, these findings highlight significant unmet need for effective medical therapy for HRS-AKI and suggest that earlier initiation of vasoconstrictors may optimize patient outcomes," said
The studies were sponsored by Mallinckrodt.
About Hepatorenal Syndrome
HRS is classified into two distinct types – hepatorenal syndrome type-1 and type-2.1 HRS-1 is a rapidly progressive condition that leads to renal failure.1 It is often a challenge to effectively diagnose in a timely manner due to its diagnosis of exclusion.2 At present, there are no drug therapies approved for the treatment of HRS-1 in the
About Terlipressin
Terlipressin is a potent vasopressin analogue selective for V1 receptors being investigated for the treatment of HRS-1 in the
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 www.mallinckrodt.com.
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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.
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References
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2 Sanyal AJ,
3 Gines P, Sola E, Angeli P, et al. Hepatorenal syndrome. Nature Reviews. 2018; 4:23.
4 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.
5 Allegretti AS, Jamil K, Verleger K, et al. Serum Creatinine ≥5 mg/dL is Associated with Decreased Safety and Efficacy in Patients Treated with Terlipressin for Hepatorenal Syndrome-Acute Kidney Injury (HRS-AKI) in the
6 Boyer TD, Sanyal AJ,
7 Piano S, Schmidt HH, Ariza X, et al. Association between grade of acute on chronic liver failure and response to terlipressin and albumin in patients with hepatorenal syndrome. Clin Gastroenterol Hepatol. 2018;16:1792-1800.e1793.
8 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.
9 C Pant, B S Jani, M Desai, A Deshpande,
10
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