Hepatorenal Syndrome in Cirrhotic Patients: Terlipressine Is A Safe and Efficient Treatment; Propranolol and Digitalic Treatments: Precipitating and Preventing Factors?

A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial of Terlipressin for Type 1 Hepatorenal Syndrome

“…[17][18][19] In this study, patients who received terlipressin had significant improvements in renal function relative to controls, although the difference between the treated (25%) and control groups (12.5%) did not reach statistical significance when the primary end point of treatment success at day 14 was used. The end point routinely applied in the literature, HRS reversal (SCr level ≤1.5 mg/dL), [14][15][16][17][23][24][25] was, however, achieved in significantly more patients receiving terlipressin (33.9%) as compared with controls (12.5%). The response to treatment was also durable, with a HRS type 1 relapse rate of 5.3% among responders to terlipressin vs 14.3% for those who responded to placebo.…”

“…The treatment success end point was developed by the study investigators as a more stringent version of the traditional end point of "HRS reversal," which is defined as a decrease in SCr level to ≤1.5 mg/dL during treatment without dialysis. [14][15][16][17][23][24][25] An analysis of HRS reversal was also planned to provide a comparison between the current study and data published in the literature.…”

“…The estimated rate of treatment success at day 14 for the terlipressin group was based on largely uncontrolled studies published in the literature, which reported HRS reversal in approximately 50%-60% of patients treated with terlipressin and albumin. [14][15][16][17][23][24][25] Considering the more rigorous definition of treatment success used in this study (ie, SCr level ≤1.5 mg/dL on 2 occasions at least 48 hours apart, without dialysis, death, or recurrence of HRS within the 14 day treatment period), it was projected that 35% and 5% of patients in the terlipressin plus albumin and placebo plus albumin groups, respectively, would achieve the primary end point.…”

Hepatorenal Syndrome and Novel Advances in its Management

“…Systemic vasoconstrictors used for HRS include vasopressin analogues (ornipressin) [25,26,27], somatostatin analogues (octreotide) [28,29,30,31], alpha-adrenergic agonists including midodrine [32] and noradrenaline [33,34,35,36,37,38]. Medical literature is abundant on clinical studies regarding terlipressin, a vasopressin analogue, for the treatment of HRS [39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56]. In many studies, vasoconstrictors were given in combination with albumin, which probably improves their efficacy [57].…”

“…Many clinicians have started to use terlipressin in patients with HRS but the majority of these studies had small size and uncontrolled design [39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56]. We have previously evaluated efficacy and safety of terlipressin in the treatment of hepatorenal syndrome by a pooled analysis of observational (uncontrolled) studies [60].…”