Standard of Care Versus Octreotide in Angiodysplasia-Related Bleeding (the OCEAN Study): A Multicenter Randomized Controlled Trial.

Autor:	Goltstein LCMJ; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands., Grooteman KV; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands., Bernts LHP; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands., Scheffer RCH; Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands., Laheij RJF; Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands., Gilissen LPL; Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, the Netherlands., Schrauwen RWM; Department of Gastroenterology, Bernhoven Hospital, Uden, the Netherlands., Talstra NC; Department of Gastroenterology, Bernhoven Hospital, Uden, the Netherlands., Zuur AT; Department of Gastroenterology, Tjongerschans, Heerenveen, the Netherlands., Braat H; Department of Gastroenterology, Gelre Hospital, Apeldoorn, the Netherlands., Hadithi M; Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, the Netherlands., Brouwer JT; Department of Gastroenterology, Reinier de Graaf Gasthuis, Delft, the Netherlands., Nagengast WB; Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, the Netherlands., Oort FA; Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands., Tenthof van Noorden J; Department of Gastroenterology and Hepatology, St. Antonius Hospital, Nieuwegein, the Netherlands., Kievit W; Department of Health Evidence, Radboud University Medical Center, Nijmegen, the Netherlands., van Geenen EJM; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands., Drenth JPH; Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, the Netherlands. Electronic address: joostphdrenth@cs.com.
Jazyk:	angličtina
Zdroj:	Gastroenterology [Gastroenterology] 2024 Apr; Vol. 166 (4), pp. 690-703. Date of Electronic Publication: 2023 Dec 28.
DOI:	10.1053/j.gastro.2023.12.020
Abstrakt:	Background & Aims: Gastrointestinal angiodysplasias are vascular anomalies that may result in transfusion-dependent anemia despite endoscopic therapy. An individual patient data meta-analysis of cohort studies suggests that octreotide decreases rebleeding rates, but component studies possessed a high risk of bias. We investigated the efficacy of octreotide in reducing the transfusion requirements of patients with angiodysplasia-related anemia in a clinical trial setting. Methods: The study was designed as a multicenter, open-label, randomized controlled trial. Patients with angiodysplasia bleeding were required to have had at least 4 red blood cell (RBC) units or parental iron infusions, or both, in the year preceding randomization. Patients were allocated (1:1) to 40-mg octreotide long-acting release intramuscular every 28 days or standard of care, including endoscopic therapy. The treatment duration was 1 year. The primary outcome was the mean difference in the number of transfusion units (RBC + parental iron) between the octreotide and standard of care groups. Patients who received at least 1 octreotide injection or followed standard of care for at least 1 month were included in the intention-to-treat analyses. Analyses of covariance were used to adjust for baseline transfusion requirements and incomplete follow-up. Results: We enrolled 62 patients (mean age, 72 years; 32 men) from 17 Dutch hospitals in the octreotide (n = 31) and standard of care (n = 31) groups. Patients required a mean number of 20.3 (standard deviation, 15.6) transfusion units and 2.4 (standard deviation, 2.0) endoscopic procedures in the year before enrollment. The total number of transfusions was lower with octreotide (11.0; 95% confidence interval [CI], 5.5-16.5) compared with standard of care (21.2; 95% CI, 15.7-26.7). Octreotide reduced the mean number of transfusion units by 10.2 (95% CI, 2.4-18.1; P = .012). Octreotide reduced the annual volume of endoscopic procedures by 0.9 (95% CI, 0.3-1.5). Conclusions: Octreotide effectively reduces transfusion requirements and the need for endoscopic therapy in patients with angiodysplasia-related anemia. Clinicaltrials: gov, NCT02384122. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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