Key result
Landiolol increased the proportion of patients achieving a heart rate of 60-94 beats/min at 24 hours compared to conventional therapy alone (54.7% vs 33.3%, OR 2.80) across most subgroups of patients with sepsis-related tachyarrhythmia.
Why the study?
Patient characteristics may impact outcomes of landiolol therapy in sepsis-related tachyarrhythmias, but their effect on its efficacy and safety required evaluation.
Does landiolol improve heart rate control in patients with sepsis-related tachyarrhythmia?
RCT (n=151)
Open-label
1:1
Yes
Does landiolol improve heart rate control in patients with sepsis-related tachyarrhythmia?
Odds Ratio: 2.8 (95% CI 1.37–5.69)
Absolute Event Rate: 54.7% vs 33.3%
Absolute Risk Reduction: 21.3%
Landiolol effectively and safely reduces heart rate in patients with sepsis-related tachyarrhythmia across various baseline characteristics, without increasing adverse events.
Supports landiolol for rate control in sepsis tachyarrhythmia; extends randomized evidence across subgroups.
BACKGROUND: The J-Land 3S trial demonstrated that landiolol is effective and tolerated for treating sepsis-related tachyarrhythmias. Patient characteristics (e.g. baseline heart rate [HR], type of tachyarrhythmia, and concomitant disorders) may impact the outcomes of landiolol therapy. We performed subanalyses of J-Land 3S to evaluate the impact of patient characteristics on the efficacy and safety of landiolol for treating sepsis-related tachyarrhythmia. METHODS: = 151) hospitalised with sepsis at 54 participating hospitals in Japan with HR ≥100 beats/min for ≥10 min accompanied by diagnosis of tachyarrhythmia were randomised 1:1 to conventional sepsis therapy alone (control group) or conventional sepsis therapy plus landiolol (landiolol group). The efficacy and safety of landiolol were assessed in prespecified analyses of patients divided into subgroups by baseline characteristics and in post hoc, multivariate analyses with adjustment for age and HR at baseline. FINDINGS: The percentage of patients with HR of 60-94 beats/min at 24 h after randomisation (primary endpoint) was greater in the landiolol group in most subgroups in univariate unadjusted analyses and in multivariate logistic regression. The incidence of new-onset arrhythmia by 168 h and mortality by 28 days were also lower in the landiolol group in most subgroups in univariate and multivariate Cox proportional hazards models. No subgroups showed a markedly higher incidence of adverse events in univariate or multivariate logistic regression analyses. INTERPRETATION: These results of the J-Land 3S study suggest that the efficacy and safety of landiolol are generally unaffected by key patient characteristics. FUNDING: Ono Pharmaceutical Co., Ltd.
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Matsuda et al. (2020) conducted an RCT in Sepsis-related tachyarrhythmia (n=151). Landiolol vs. Conventional sepsis therapy alone was evaluated on Heart rate of 60-94 beats/min at 24 hours after randomization (OR 2.80, 95% CI 1.37-5.69). Landiolol increased the proportion of patients achieving a heart rate of 60-94 beats/min at 24 hours compared to conventional therapy alone (54.7% vs 33.3%, OR 2.80) across most subgroups of patients with sepsis-related tachyarrhythmia.
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