Sistema de Salut de Catalunya
Institut Català de la Salut
[Michel-Behnke I] Department of Paediatrics and Adolescent Medicine, Division of Paediatric Cardiology, Medical University of Vienna, General Hospital Vienna, Vienna, Austria. [Müller M] Department of Anaesthesiology and Intensive Care Medicine, Paediatric Heart Centre Giessen, University Hospital Giessen and Marburg GmbH, Giessen, Germany. [Stiller B] Department of Congenital Heart Disease and Paediatric Cardiology, Faculty of Medicine, Heart Centre Freiburg University, University of Freiburg, Freiburg, Germany. [Kriebel T] Department of Paediatrics and Paediatric Cardiology, Westpfalz Hospital, Kaiserslautern, Germany. [Kanaan M] Department of Paediatric Cardiology, Children’s Heart Centre Aachen, University Hospital RWTH Aachen, Aachen, Germany. [Környei L] Gottsegen National Cardiovascular Centre, Paediatric Heart Centre, Budapest, Hungary. [Roses-Noguer F] Servei de Cardiologia Pediàtrica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Honorary Paediatric EP Consultant, Royal Brompton and Harefield Hospital, London, UK and European Reference Network for Rare, Low Prevalence and Complex Diseases of the Heart (ERN GUARD-Heart)
Vall d'Hebron Barcelona Hospital Campus
2025-04-08T09:01:13Z
2025-04-08T09:01:13Z
2025-02
Heart rate; Paediatrics; Supraventricular tachycardia
Frecuencia cardíaca; Pediatría; Taquicardia supraventricular
Freqüència cardíaca; Pediatria; Taquicàrdia supraventricular
Aims Landiolol, an ultra-fast acting super-selective beta-blocker, was investigated for the first time in Europe in a prospective clinical study for the management of supraventricular tachycardia (SVT) among paediatric patients. Methods and results The LANDI-PED study was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. Sixty patients in surgical and non-surgical settings aged ≥1 day to <18 years with SVTs of various aetiologies received landiolol as a continuous intravenous infusion starting with 5 μg/kg/min titrated up to 40 μg/kg/min depending on heart rate (HR) reduction for up to a maximum of 24 h. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 min of infusion start. The primary endpoint was achieved in 15 (25.0%) patients. A total of 24 (40.0%) patients achieved a HR reduction of at least 20% within 210 min of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 min of −13.2 (±11.5)% (P < 0.0001) in the overall population. By infusion end, 51.7% of patients achieved HR reduction of at least 20% from baseline and/or NSR conversion. The PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%). Conclusion Landiolol is effective and safe in the treatment of SVTs in the paediatric population as demonstrated by reduction of HR and/or restoring NSR. Landiolol was well tolerated with no novel safety concerns reported. Clinical Trial Registration EU Clinical Trial Register; EudraCT Number: 2015-001129-17.
The study was sponsored by the AOP Orphan Pharmaceuticals GmbH.
Article
Published version
English
Avaluació de resultats (Assistència sanitària); Infants; Antiarítmics cardíacs - Ús terapèutic; Taquicàrdia - Tractament; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome; DISEASES::Cardiovascular Diseases::Heart Diseases::Arrhythmias, Cardiac::Tachycardia::Tachycardia, Supraventricular; Other subheadings::Other subheadings::Other subheadings::/drug therapy; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Cardiovascular Agents::Anti-Arrhythmia Agents; Other subheadings::Other subheadings::/therapeutic use; NAMED GROUPS::Persons::Age Groups::Child; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento; ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::arritmias cardíacas::taquicardia::taquicardia supraventricular; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos cardiovasculares::antiarrítmicos; Otros calificadores::Otros calificadores::/uso terapéutico; DENOMINACIONES DE GRUPOS::personas::Grupos de Edad::niño
Oxford University Press
EP Europace;27(2)
https://doi.org/10.1093/europace/euaf025
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
Articles científics - HVH [3437]
