Landiolol is effective and safe in paediatric supraventricular tachycardia: Evidence from a European prospective multicentre open-label Phase III study (LANDI-PED)

Abstract Background and 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 LANDI-PED was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. 60 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 hours. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 minutes of infusion start. Results 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 minutes of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 minutes 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. PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%). Conclusions 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. Trial registration EU Clinical Trial Register; EudraCT Number: 2015-001129-17