BACKGROUND: Atrial fibrillation and atrial flutter occur commonly in patients with heart failure. Ultrashort-acting β-blockers, including landiolol, can rapidly control heart rate. As part of postmarketing surveillance for landiolol in Japan, a real-world drug-use survey (AF-CHF landiolol survey) was established for the treatment of atrial fibrillation and atrial flutter in patients with heart failure. We report the safety and effectiveness of landiolol from this survey, focusing on adverse events/adverse drug reactions. METHODS: Consecutive patients with cardiac dysfunction who received landiolol (continuous intravenous infusion, starting at 1μg/kg/min) for atrial fibrillation or atrial flutter in routine clinical practice in Japan were enrolled between June 2014 and May 2016. Safety variables included adverse events and adverse drug reactions (number of patients and events, incidence rate, types, seriousness). Effectiveness variables included the proportion of patients with a ≥20% decrease in heart rate. RESULTS: Data were available for 1121 patients (safety analysis set); 888 patients were evaluable for effectiveness parameters. Mean (± standard deviation) patient age was 72.5±13.5 years, 57.2% were male. Most patients (84.2%) received landiolol for atrial fibrillation. Overall, 174 adverse events occurred in 140 patients (12.5%), including 105 serious adverse events. The most common type of adverse events was cardiac (60 events). Seventy-five events in 63 patients were categorized as adverse drug reactions (5.6% of patients). Mean heart rate decreased substantially after treatment with landiolol, by ≥20% in 77.5% of patients. CONCLUSIONS: In a real-world setting in Japan, landiolol for the treatment of atrial fibrillation or atrial flutter with heart failure was acceptable without new safety concerns, and most patients achieved effective heart rate control during their arrhythmias.
BACKGROUND:Atrial fibrillation and atrial flutter occur commonly in patients with heart failure. Ultrashort-acting β-blockers, including landiolol, can rapidly control heart rate. As part of postmarketing surveillance for landiolol in Japan, a real-world drug-use survey (AF-CHFlandiolol survey) was established for the treatment of atrial fibrillation and atrial flutter in patients with heart failure. We report the safety and effectiveness of landiolol from this survey, focusing on adverse events/adverse drug reactions. METHODS: Consecutive patients with cardiac dysfunction who received landiolol (continuous intravenous infusion, starting at 1μg/kg/min) for atrial fibrillation or atrial flutter in routine clinical practice in Japan were enrolled between June 2014 and May 2016. Safety variables included adverse events and adverse drug reactions (number of patients and events, incidence rate, types, seriousness). Effectiveness variables included the proportion of patients with a ≥20% decrease in heart rate. RESULTS: Data were available for 1121 patients (safety analysis set); 888 patients were evaluable for effectiveness parameters. Mean (± standard deviation) patient age was 72.5±13.5 years, 57.2% were male. Most patients (84.2%) received landiolol for atrial fibrillation. Overall, 174 adverse events occurred in 140 patients (12.5%), including 105 serious adverse events. The most common type of adverse events was cardiac (60 events). Seventy-five events in 63 patients were categorized as adverse drug reactions (5.6% of patients). Mean heart rate decreased substantially after treatment with landiolol, by ≥20% in 77.5% of patients. CONCLUSIONS: In a real-world setting in Japan, landiolol for the treatment of atrial fibrillation or atrial flutter with heart failure was acceptable without new safety concerns, and most patients achieved effective heart rate control during their arrhythmias.