Velez JCQ, Befeler A, Kurtz I, et al.
Terlipressin Improves Renal Replacement Therapy–Free Survival in
Hepatorenal Syndrome Type 1
ASN Annual Meeting 2020 -- Digital Meeting
J Am Soc Nephrol
(Oct) 31:15A 2020

BACKGROUND
Hepatorenal syndrome type 1 (HRS-1) is an ominous form
of acute kidney injury in patients with cirrhosis. Recently, the results of
the randomized placebo (PBO)-controlled trial (RCT) CONFIRM demonstrated that
terlipressin (TERLI) is effective in reversing HRS-1 and in reducing the
cumulative need for renal replacement therapy (RRT). However, whether TERLI
reduces the need for RRT among survivors has not been
determined.
METHODS
CONFIRM (NCT02770716) was a North American
RCT (n=300) that compared HRS-1 reversal rates between patients treated with
albumin plus TERLI (n=199) or albumin plus PBO (n=101) (2:1). We conducted a
post hoc intention-to-treat analysis to assess the incidence of RRT among
CONFIRM survivors. We also conducted a pooled analysis of the 3 TERLI RCTs in
HRS-1 (OT-0401 [NCT00089570], REVERSE [NCT01143246], and CONFIRM) to examine
90-day RRT-free survival rates.
RESULTS
In CONFIRM, the
cumulative incidences of need for RRT for TERLI at day 14, 30, and 90 were
23%, 26%, and 29% compared with 35%, 36%, and 39% for patients assigned to
PBO (P=0.03, 0.07, and 0.1, respectively). Among survivors,
significantly fewer TERLI-treated patients remained dependent on RRT at day
14, 30, and 90 (22%, 26%, and 30%, respectively) compared with PBO (39%, 43%,
and 46%; P<0.01, P=0.03,
and P=0.05, respectively). The 90-day RRT-free survival rate
was 35% in the TERLI group vs 30% in the PBO group (P=0.08), with a
numerically longer median number of days in the TERLI group (20 vs 11).
Pooled analysis of the 3 RCTs revealed a greater 90-day RRT-free survival
rate for TERLI-treated (n=352) compared with PBO-treated (n=256) patients
(37% vs 29%, P=0.03; OR [95% CI], 1.47 [1.04,
2.07]).
CONCLUSION
Treatment with TERLI added to albumin
decreased the rate of RRT and improved RRT-free survival in patients with HRS
-1. This is the first pharmacological intervention proven to reduce the need
for RRT in patients with HRS-1. Because of the significant impact of RRT on
quality of life, this observation expands the clinical benefit of TERLI and
enhances the reported efficacy of TERLI in inducing HRS-1 reversal.

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