2026-04-13T03:59:10Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/129102025-10-24T10:38:58Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Michel-Behnke, Ina author Müller, Matthias author Stiller, Brigitte author Kriebel, Thomas author Kanaan, Majed author Környei, László author Roses-Noguer, Ferran author 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. http://hdl.handle.net/11351/12910 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 Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED)