Real-world data of terlipressin in hospitalized patients in the U.K. with hepatorenal syndrome type 1 is published in Alimentary Pharmacology and Therapeutics.- Mallinckrodt

Mallinckrodt Plc announced publication of findings from a medical chart study to assess the real-world use of terlipressin and other vasopressors in hospitalized patients with hepatorenal syndrome type 1 (HRS-1), an acute and life-threatening syndrome involving acute kidney failure in people with cirrhosis.

The study, funded by Mallinckrodt, found that terlipressin was associated with an improvement in kidney function among HRS-1 patients as measured by a reduction in serum creatinine (SCr). The results of the study were published in the peer-reviewed journal Alimentary Pharmacology and Therapeutics.

Medical records of 250 adult patients with HRS-1 from 26 centers in the U.K. were reviewed, 225 of whom were treated with vasopressor therapy . The majority of patients were treated with terlipressin (n=203, 90 percent) with a median duration of therapy of six days, in line with European Association For The Study Of The Liver (EASL) guidelines recommending terlipressin for first-line use in patients with HRS-1. A complete response (SCr reduction of ?1.5 mg/dL) was observed in 50 percent of patients treated with terlipressin and 23 percent of those treated with other vasopressors. Overall response, as measured by a complete response or partial response (SCr reduction of at least 20 percent from baseline but SCr >1.5 mg/dL), was demonstrated in 73 percent of patients treated with terlipressin and 59 percent treated with other vasopressors.

In addition, lower SCr at the time of treatment initiation was associated with higher complete response rates.

“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 Kevin Moore, M.D., UCL Institute Of Liver And Digestive Health, Royal Free Hospital, University College London.

HRS-1 has a median survival time of approximately two weeks and greater than 80 percent mortality within three months if left untreated. At present, there are no approved drug therapies for HRS-1 in the U.S. or Canada. HRS-1 is estimated to affect between 30,000 and 40,000 patients in the U.S. annually. The company announced in April the FDA accepted its New Drug Application for review of terlipressin to treat HRS-1.

See-Moore 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.