Safety and Efficacy of Landiolol Hydrochloride in Children with Tachyarrhythmia of Various Etiologies

The safety and efficacy of landiolol have not been fully elucidated in pediatric patients. This study aimed to clarify the safety and efficacy of landiolol in a pediatric cohort. We retrospectively assessed the clinical features of 21 pediatric patients who were administered landiolol at our hospital. We also investigated the rates of sinus rhythm conversion and heart rate response. The median patient age was 7 months (interquartile range 1–13 months). The etiology of tachyarrhythmia was junctional ectopic tachycardia in 10 patients (47.6%), atrial tachycardia in 10 patients (47.6%), and ventricular tachycardia in 1 patient (4.8%). Of the 21 children, 18 (85.7%) had congenital heart defects, including 14 (77.8%) in whom a landiolol infusion was performed perioperatively. The landiolol infusion was effective in 18 pediatric patients (85.7%), as measured by the conversion to sinus rhythm or a reduced heart rate. Atrial tachycardia in the perioperative period was terminated in all patients. Of 7 patients with tachyarrhythmias unrelated to the perioperative period, landiolol was effective in 5. No adverse effects were reported in any patient. Landiolol infusion is effective and safe in pediatric patients with tachyarrhythmia of various etiologies, especially those with atrial tachyarrhythmia during the perioperative period.

Preventive effect of low-dose landiolol on postoperative atrial fibrillation study (PELTA study)

Objective To investigate the efficacy of prophylactic administration of low-dose landiolol on postoperative atrial fibrillation (POAF) in patients after cardiovascular surgery. Methods Consecutive 150 patients over 70 years of age who underwent cardiovascular surgery for valvular, ischemic heart, and aortic diseases were enrolled in this single-center prospective randomized control study from 2010 to 2014. They were assigned to three treatment groups: 1γ group (landiolol at 1 μg/kg/min), 2γ group (landiolol at 2 μg/kg/min), or control group (no landiolol). In the two landiolol groups, landiolol hydrochloride was intravenously administered for a period of 4 days postoperatively. Electrocardiography was continuously monitored during the study period, and cardiologists eventually assessed whether POAF occurred or not. Results POAF occurred in 24.4% of patients in the control group, 18.2% in 1γ group, and 11.1% in 2γ group (p = 0.256). Multivariate logistic regression analysis showed that the incidence of POAF tended to decrease depending on the dose of landiolol (trend-p = 0.120; 1γ group: OR = 0.786, 95% CI 0.257–2.404; 2γ group: OR = 0.379, 95% CI 0.112–1.287). Subgroup analysis showed a significant dose-dependent reduction in POAF among categories of female sex, non-use of angiotensin II receptor blockers (ARBs) before surgery, and valve surgery (each trend-p = 0.02, 0.03, and 0.004). Conclusions These findings indicate that prophylactic administration of low-dose landiolol may not be effective for preventing the occurrence of POAF in overall patients after cardiovascular surgery, but the administration could be beneficial to female patients, patients not using ARBs preoperatively, and those after valvular surgery.

Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients

Background Recurrence of cancer after curative surgery is a major problem after most cancer treatments. Increased sympathetic activity during the perioperative period could promote cancer cell invasion to blood vessels and angiogenesis, resulting in cancer metastasis. Recent studies showed that use of beta blockers can be associated with the prolonged survival of patients with cancer. The objective of this study is to evaluate the preventive effects of landiolol hydrochloride, which is an ultra-short-acting beta-1-selective blocker that has been developed in Japan, on reducing recurrence of cancer after curative surgery for patients with lung cancer. Methods The present study is a phase III, multicenter, randomized trial with two parallel groups of patients with lung cancer, comparing surgery alone and surgery with landiolol administration for three days during the perioperative period. A total of 400 patients will be enrolled from 12 Japanese institutions. The primary endpoint is two-year relapse-free survival and overall survival after curative surgery for lung cancer. The secondary endpoints are additional treatment after recurrence of cancer, safety events, and the incidence of postoperative complications. Discussion The principal question addressed in this trial is whether landiolol can reduce recurrence of cancer after curative surgery for lung cancer. Trial registration Japan Registry of Clinical Trials, jRCT2011180004. Registered 17 January 2019.

P6159The efficacy of heart rate reduction with bisoprolol transdermal patch prior to coronary computed tomography angiography

Background Oral or intravenous beta-blockers have commonly been used to control the heart rate (HR) prior to coronary computed tomography angiography (CCTA). However, the administration after arrival at the hospital was time-consuming, and could not achieve the target heart rate in several cases. Moreover, the efficacy of transdermal beta blockers in HR control for patients who underwent CCTA have not been fully reported. Purpose The purpose of this study was to clarify the usefulness of the bisoprolol patch prior to the arrival at the hospital in HR control for patients who underwent CCTA. Methods A total of 282 consecutive patients (160 male, age 64±12 years) who underwent CCTA were included in this study. The bisoprolol transdermal patch (8mg) was administered before arrival at the hospital in 191 patients (beta group), and no additional medication was administered in 91 patients (control group). Intravenous landiolol hydrochloride was administered when HR remained over 65 bpm on arrival at the hospital. The HR on arrival, during and after CCTA was evaluated. Results The baseline HR was significantly higher in the beta group (80±15 vs. 72±15, P<0.0001). However, the achievement rate of HR ≤65 bpm on arrival was significantly higher in the beta group (56.5% vs. 44.0%, P=0.047). Thus, additional treatment with intravenous landiolol hydrochloride was administered to 43.5% of the patients in the beta group and 56.0% of those in the control group. There were no significant differences in the HR during and after CCTA between the 2 groups. Multivariate analysis revealed that the use of bisoprolol transdermal patch (OR, 3.54; 95% CI 1.67–7.51, P=0.001) and the baseline HR (OR, 0.91; 95% CI 0.89–0.94, P<0.0001) were significant predictors of the achievement rate of HR ≤65 bpm on arrival. There were no serious adverse effects throughout CCTA in all patients. Conclusions The administration of bisoprolol transdermal patch before arrival at the hospital was useful for HR control and reduced the rate of additional intravenous treatment in patients who underwent CCTA.