2025 Volume 89 Issue 6 Pages 784-792
Background: Landiolol is a short-acting, intravenously administered β1-adrenergic receptor blocker that can rapidly control heart rate in refractory and urgent fatal arrhythmias (ventricular fibrillation [VF] and hemodynamically unstable ventricular tachyarrhythmia [VT]). This indication was approved in Japan in 2019 based on results of the J-Land II clinical trial. We conducted post-marketing surveillance (PMS) to assess the safety and effectiveness of landiolol in real-world settings in Japan.
Methods and Results: This PMS examined the safety, focusing on adverse drug reactions (ADRs) related to the safety specifications (SS), namely hypotension-decreased blood pressureSS, bradycardiaSS, and heart failureSS, and effectiveness (physician-rated) in patients treated with landiolol for the target indication. Among 253 registered patients, 13.0% experienced ADRs related to the safety specifications: bradycardiaSS(7.1%), hypotension-decreased blood pressureSS(6.7%), and heart failureSS(1.2%). Serious ADRs related to the safety specifications occurred in 6.7% of patients, including those related to bradycardiaSS(3.2%), hypotension-decreased blood pressureSS(3.2%), and heart failureSS(1.2%). The effectiveness of landiolol within 48 h after starting treatment was rated as effective (52.4%), slightly effective (27.0%), not effective (18.7%), and indeterminate (2.0%).
Conclusions: The safety profile of landiolol in this PMS was similar to that observed in a prior clinical trial, and no new safety signals were identified. Landiolol is an option for treating refractory and potentially fatal VF or hemodynamically unstable VT.
