Yamashita Takeshi, Nakasu Yukiko, Mizutani Hiroto, Sumitani Kenji
The Cardiovascular Institute Tokyo Japan.
Pharmacovigilance Division, Ono Pharmaceutical Co. Ltd. Osaka Japan.
Circ Rep. 2020 Dec 22;3(1):34-43. doi: 10.1253/circrep.CR-20-0119.
The aim of the prospective post-marketing AF-CHF Landiolol Survey was to evaluate the safety and effectiveness of landiolol for the treatment of atrial fibrillation or atrial flutter in patients with cardiac dysfunction in clinical practice in Japan. This analysis reports mid-term prognoses with a focus on switching from landiolol to oral β-blockers. The AF-CHF Landiolol Survey took place between June 2014 and May 2016 and involved 1,121 patients with cardiac dysfunction and atrial fibrillation/atrial flutter. Data collected about switching from landiolol to oral β-blockers were analyzed in relation to all-cause mortality within 180 days after landiolol initiation. Among 1,002 patients with available follow-up data, the 6-month all-cause mortality rate was 14. 6% (n=146 patients), of whom 39.7% had died from heart failure (HF). Kaplan-Meier survival curves showed significantly longer survival in patients who had switched to oral β-blockers vs. those who had not, with hazard ratios of 0.39 (95% confidence interval [CI] 0.28-0.55) for all-cause mortality and 0.40 (95% CI: 0.23-0.70) for death from HF. Only male sex and advanced age were independently associated with all-cause mortality and death from HF. This large-scale routine practice survey of landiolol in HF patients with atrial fibrillation/flutter showed high mid-term all-cause mortality. Switching from landiolol to oral β-blockers was apparently, although not independently, associated with lower all-cause mortality and death from HF.
前瞻性上市后房颤合并心力衰竭(AF-CHF)兰地洛尔调查的目的是评估在日本临床实践中,兰地洛尔治疗心功能不全患者房颤或房扑的安全性和有效性。本分析报告中期预后情况,重点关注从兰地洛尔转换为口服β受体阻滞剂的情况。AF-CHF兰地洛尔调查于2014年6月至2016年5月进行,纳入了1121例心功能不全合并房颤/房扑的患者。收集的关于从兰地洛尔转换为口服β受体阻滞剂的数据,针对兰地洛尔开始使用后180天内的全因死亡率进行了分析。在1002例有可用随访数据的患者中,6个月全因死亡率为14.6%(n = 146例患者),其中39.7%死于心力衰竭(HF)。Kaplan-Meier生存曲线显示,转换为口服β受体阻滞剂的患者比未转换者的生存时间显著更长,全因死亡率的风险比为0.39(95%置信区间[CI] 0.28 - 0.55),死于HF的风险比为0.40(95% CI:0.23 - 0.70)。仅男性和高龄与全因死亡率及死于HF独立相关。这项针对房颤/房扑HF患者的兰地洛尔大规模常规实践调查显示中期全因死亡率较高。从兰地洛尔转换为口服β受体阻滞剂虽然并非独立相关,但显然与较低的全因死亡率及死于HF相关。