Terlipressin plus Albumin for the Treatment of Type 1 Hepato
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Details of the phase-3 CONFIRM trial show the vasopressin analog terlipressin can reverse the effects of type 1 hepatorenal syndrome (HRS-1), although not without potentially serious side effects.

The study, published in the New England Journal of Medicine, examined the experimental drug in HRS-1 patients who also had cirrhosis, ascites, and rapidly progressing kidney failure. Albumin therapy was strongly recommended for all patients.

Investigators 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. The primary endpoint was verified reversal of HRS.

A total of 300 patients underwent randomization — 199 were assigned to the terlipressin group and 101 to the placebo group.

--A verified reversal of HRS was reported in 63 patients in the terlipressin group and 17 patients in the placebo group.

--With respect to the prespecified secondary endpoints, HRS reversal, defined as any serum creatinine level of 1.5 mg per deciliter or less during the first 14 days, was reported in 78 patients in the terlipressin group and 18 in the placebo group; HRS reversal without renal-replacement therapy by day 30, in 68 and 17, respectively; HRS reversal among patients with systemic inflammatory response syndrome, in 31 and 3, respectively; and verified reversal of HRS without recurrence by day 30, in 52 and 17, respectively.

--At day 90, liver transplantations had been performed in 46 patients in the terlipressin group and 29 patients in the placebo group, and death occurred in 101 and 45, respectively.

--More adverse events, including abdominal pain, nausea, diarrhea, and respiratory failure, occurred with terlipressin than with placebo.

--Death within 90 days due to respiratory disorders occurred in 22 patients in the terlipressin group and 2 patients in the placebo group.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2008290
Like
Comment
Share