MedElevator
Войти в исследования Circulation journal : official journal of the Japanese Circulation Society · 2025
Post-Marketing Surveillance of the Safety of Landiolol in Patients With Recurrent Hemodynamically Unstable Ventricular Tachyarrhythmias.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Shiga Tsuyoshi, Shiozaki Masato, Takahashi Rika, Matsumoto Ryoji, Fukui Masato
Аннотация
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.
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.