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

Abstract

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.