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  • New Terlivaz for injection data on hepatorenal syn...

New Terlivaz for injection data on hepatorenal syndrome reversal is presented at the Society of Critical Care Medicine 2023 Critical Care Congress

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Published:24th Jan 2023

Mallinckrodt plc announced the presentation of results from a retrospective analysis of three North American-centric, Phase III, randomized, placebo-controlled studies comparing the incidence of hepatorenal syndrome (HRS) reversal with baseline acute-on-chronic liver failure (ACLF) grade in adults with rapid reduction in kidney function treated with Terlivaz plus albumin versus those treated with placebo plus albumin

Investigators will present the findings during an oral presentation at the SCCM 2023 Critical Care Congress on January 22, taking place in San Francisco, CA from January 21-24.

The retrospective analysis used pooled data from the OT-0401, REVERSE, and CONFIRM Phase III studies to compare the incidence of HRS reversal by baseline ACLF grade in patients treated with terlipressin plus albumin versus placebo plus albumin for up to 14 days. Severity of ACLF was graded according to the number of organ failures (ACLF grade 0-1, grade 2, and grade 3). The incidence of HRS reversal was defined as at least one serum creatinine value of less than 1.5 mg/dL while on treatment.

In the pooled analysis population (n=607), 278 patients had ACLF grade 0-1 (terlipressin: n=164; placebo: n=114), 208 patients had ACLF grade 2 (terlipressin: n=116; placebo: n=92), and 121 patients had ACLF grade 3 (terlipressin: n=72; placebo: n=49). The incidence of HRS reversal in terlipressin-treated patients decreased with increasing ACLF grade (ACLF grade 0-1: 43% (n=71/164); ACLF grade 2: 28% (n=32/116); ACLF grade 3: 19% (n=14/72)), whereas HRS reversal was similar across ACLF grades in placebo-treated patients (ACLF grade 0-1: 18% (n=21/114); ACLF grade 2: 15% (n=14/92); ACLF grade 3: 14% (n=7/49)).

Additionally, a higher percentage of terlipressin-treated patients with ACLF grade 0-1 or grade 2 achieved HRS reversal compared with those in the respective placebo-treated groups (ACLF grade 0-1: terlipressin 43% (n=71/164) vs placebo 18% (n=21/114); ACLF grade 2: terlipressin 28% (n=32/116) vs placebo 15% (n=14/92)) (p<0.0001 and p="0.02," respectively). no differences in the incidence of hrs reversal were observed between terlipressin- (19%; n="14/72)" and placebo- (14%; n="7/49)" treated patients with aclf grade 3 (p="0.46)."

Condition: Hepato-Renal Syndrome
Type: drug

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