Trial reportAlimentary pharmacology & therapeutics2025
Bradycardia and Other Arrhythmias in Patients With Hepatorenal Syndrome-Acute Kidney Injury Following Terlipressin Treatment: A Pooled Analysis of Three North American Phase III Clinical Studies.
Trial report in Alimentary pharmacology & therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase III Study of Intravenous Terlipressin in Patients With Hepatorenal Syndrome Type 1
A Multi-Center, Randomized, Placebo-controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Lucassin® (Terlipressin) (The REVERSE Study)
A Multi-Center, Randomized, Placebo Controlled, Double-Blind Study to Confirm Efficacy and Safety of Terlipressin in Subjects With Hepatorenal Syndrome Type 1 (The CONFIRM Study)
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7 authors.
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Abstract
backgroundTerlipressin is the FDA-approved systemic vasoconstrictor therapy for hepatorenal syndrome-acute kidney injury (HRS-AKI)-a rapidly progressive renal failure occurring in patients with decompensated cirrhosis and ascites. Bradycardia, a known effect of terlipressin, as well as other arrhythmias, has previously been reported in terlipressin-treated patients.
aimTo assess terlipressin-related cardiac adverse events (AEs) in patients with HRS-AKI.
methodsThree North American-centric Phase III, randomised, placebo-controlled studies (OT-0401, REVERSE, CONFIRM) were pooled in the largest-to-date prospective database. Cardiac AEs were reported by the investigators for each trial and retrospectively analysed.
resultsBradycardia was the only cardiac AE reported more frequently in terlipressin-treated patients compared with placebo (6.3% [22/349] vs. 0.8% [2/249]). In the terlipressin group, no bradycardia AEs were serious, 4.5% (1/22) of patients required a dose interruption, 9.1% (2/22) required a dose reduction, and none discontinued treatment due to bradycardia. The incidences of other arrhythmia AEs were similar in both treatment groups (terlipressin: 7.4% [26/349]; placebo 8.8% [22/249]). The incidence of atrial fibrillation serious AEs (SAEs) was low (terlipressin: 0.9% [3/349]; placebo: 1.6% [4/249]). There were no AE reports of torsades de pointes, while a QT interval prolongation was reported in two patients.
conclusionsIn a pooled analysis, bradycardia was observed in 6% of terlipressin-treated patients but rarely required a dose interruption or reduction. Arrhythmia SAE incidences were low and similar in both treatment groups. Routine intensive cardiac monitoring for the detection of arrhythmias may not be necessary during terlipressin administration.
trial registrationOT-0401: NCT00089570, REVERSE: NCT01143246 and CONFIRM: NCT02770716.
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