N Engl J Med 2021 03;384(9):818-828
From the Department of Medicine, University of Toronto, Toronto (F.W.); Orphan Therapeutics, Annandale (S.C.P.), and Mallinckrodt Pharmaceuticals, Bedminster (S.E., K.J.) - both in New Jersey; the Department of Medicine, Beth Israel Deaconess Medical Center, Boston (M.P.C.); the University of Pennsylvania, Philadelphia (K.R.R.); Piedmont Transplant Institute, Piedmont Healthcare, Atlanta (R.A.R.); the Department of Medicine, Vanderbilt University Medical Center, Nashville (M.K.P.); the Department of Medicine, Baylor Scott and White All Saints Medical Center, Fort Worth (S.A.G.), and the Department of Medicine, University of Texas Southwestern Medical Center, Dallas (M.J.M.) - both in Texas; Ohio State University, Columbus (K.M.); the Department of Medicine, University of Minnesota, Minneapolis (N.L.), and the Department of Medicine, Mayo Clinic, Rochester (D.A.S.) - both in Minnesota; the Department of Medicine, University of Michigan Medical Center, Ann Arbor (P.S.); Virginia Commonwealth University, Richmond (A.J.S.); and Hepatology and Liver Transplantation, California Pacific Medical Center, San Francisco (R.T.F.).
Background: The vasoconstrictor terlipressin is used for type 1 hepatorenal syndrome (HRS-1) in many parts of the world and is part of the clinical practice guidelines in Europe.
Methods: We conducted a phase 3 trial to confirm the efficacy and safety of terlipressin plus albumin in adults with HRS-1. The patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days; in both groups, concomitant use of albumin was strongly recommended. Read More