Comparison of 1-day versus 3-day intravenous terlipressin in cirrhosis patients with variceal bleeding: A pilot randomised controlled trial.
Aliment Pharmacol Ther
; 59(5): 645-655, 2024 03.
Article
em En
| MEDLINE
| ID: mdl-38186012
ABSTRACT
BACKGROUND:
In cirrhosis patients with acute variceal bleeding (AVB), the optimal duration of vasoconstrictor therapy after endoscopic haemostasis is unclear.AIMS:
We aimed to compare efficacy of 1-day versus 3-day terlipressin therapy in cirrhosis patients with AVB post-endoscopic intervention. The primary objective was to compare rebleeding at 5 days between the two arms. Secondary objectives included rebleeding and mortality rates at 6 weeks.METHODS:
In this open-label, randomised controlled trial, cirrhosis patients with AVB were randomised to either 1-day or 3-day terlipressin therapy.RESULTS:
A total of 150 cirrhosis patients with AVB were recruited to receive either 1 day (n = 75) or 3 days (n = 75) of terlipressin therapy. One patient from 1-day arm was excluded. Modified intention-to-treat analysis included 149 patients. Baseline characteristics were comparable between the two groups. Rebleeding at 5 days 3 (4.1%; 95% confidence interval [CI] 0.4-9.0) versus 4 (5.3%; 95% CI 2.0-10.0), risk difference (RD) p = 0.726 and 5-day mortality rates 1 (1.4%; 95% CI 0-7.3) versus 1 (1.3%; 95% CI 0.2-7.0), RD p = 0.960 were similar. Rebleeding at 42 days 9 (12.2%; 95% CI 7.0-20.0) versus 10 (13.3%; 95% CI 7.0-20.0), RD p = 0.842 and mortality at 42 days 5 (6.8%; 95% CI 3.0-10.0) versus 4 (5.3%; 95% CI 2.0-10.0), RD p = 0.704 were also similar. Patients in the 1-day terlipressin therapy arm experienced significantly fewer adverse effects compared with those receiving 3 days of terlipressin therapy 28 (37.8%) versus 42 (56%), p = 0.026.CONCLUSIONS:
Our results suggest that 1 day of terlipressin therapy is associated with similar 5-day and 42-day rebleeding rates, 42-day mortality and an overall superior safety profile compared with 3-day of terlipressin therapy. These findings require to be validated in double-blinded, larger, multiethnic and multicentre studies across the various stages of cirrhosis (CTRI/2019/10/021771).
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
/
6_ODS3_enfermedades_notrasmisibles
Problema de saúde:
1_doencas_nao_transmissiveis
/
2_muertes_prematuras_enfermedades_notrasmisibles
/
6_cirrhosis
/
6_digestive_diseases
Assunto principal:
Varizes Esofágicas e Gástricas
/
Terlipressina
/
Cirrose Hepática
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Humans
Idioma:
En
Revista:
Aliment Pharmacol Ther
/
Aliment. pharmacol. ther
/
Alimentary pharmacology & therapeutics
Assunto da revista:
FARMACOLOGIA
/
GASTROENTEROLOGIA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Índia