Safety and Efficacy of Outpatient Nesiritide in Patients With Advanced Heart FailureCLINICAL PERSPECTIVE
Safety and Efficacy of Outpatient Nesiritide in Patients With Advanced Heart FailureCLINICAL PERSPECTIVE
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门诊奈西立肽治疗晚期心力衰竭患者的安全性和有效性临床视角
DOI：
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发表时间：
2008
期刊：
影响因子：
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通讯作者：
R. Evans
中科院分区：
文献类型：
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作者：
C. Yancy;H. Krum;B. Massie;M. Silver;L. Stevenson;M. Cheng;S. S. Kim;R. Evans
背景-美国心脏病学会/美国心脏协会C/D期心力衰竭患者的发病率和死亡率较高，但标准医疗和器械治疗以外的可用干预措施有限。奈西立肽可缓解呼吸困难和减少肺充血，但其风险特征尚不确定。初步数据表明，奈西立肽作为连续门诊输注给药的潜在益处。
方法和结果-第二次后续奈西立肽系列输注（FUSION II）试验是一项随机、双盲、安慰剂对照试验，针对美国心脏病学会/美国心脏协会C期患者进行门诊奈西立肽系列输注。/D心力衰竭。近期有2次心力衰竭住院、射血分数<40%、纽约心脏协会IV级症状或纽约心脏协会III级症状且肌酐清除率<60 mL/min的患者随机接受奈西立肽（2 μg/kg推注加0.01 μg/kg/min输注，持续4 - 6小时）或匹配的安慰剂，每周1次或2次，持续12周。研究期间，所有患者均接受循证医学/器械治疗，并通过仔细的疾病管理达到最佳目标。主要终点是12周时至全因死亡或心血管或肾脏住院的时间。共有911例患者接受随机化和治疗。安慰剂组和奈西立肽组的主要终点发生率分别为36.8%和36.7%（风险比，1.03; 95%可信区间，0.82 - 1.3;对数秩检验P =0.79）。两组在任何次要终点方面均无统计学显著差异，包括心血管或肾脏住院次数、存活天数和出院天数、堪萨斯城心肌病问卷评分变化或心血管死亡。两组的不良事件相似;奈西立肽与更多的低血压相关，但与预定义的肾功能恶化较少相关。
结论：对于晚期美国心脏病学会/美国心脏协会C/D期心力衰竭患者，连续门诊奈西立肽输注与强化门诊管理相比，并不能提供明显的临床获益。
2008年1月17日接收; 2008年2月5日接受。
Background— Patients with American College of Cardiology/American Heart Association stage C/D heart failure experience substantial morbidity and mortality, but available interventions beyond standard medical and device therapies are limited. Nesiritide relieves dyspnea and reduces pulmonary congestion, but its risk profile is uncertain. Pilot data suggested a potential benefit of nesiritide given as serial outpatient infusions.
Methods and Results— The Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial was a randomized, double-blind, placebo-controlled trial of outpatient serial nesiritide infusions for patients with American College of Cardiology/American Heart Association stage C/D heart failure. Patients with 2 recent heart failure hospitalizations, ejection fraction <40%, and New York Heart Association class IV symptoms, or New York Heart Association class III symptoms with creatinine clearance <60 mL/min, were randomized to nesiritide (2-μg/kg bolus plus 0.01-μg/kg-per-minute infusion for 4 to 6 hours) or matching placebo, once or twice weekly for 12 weeks. All patients were treated to optimal goals with evidence-based medical/device therapy facilitated by careful disease management during the study. The primary end point was time to all-cause death or cardiovascular or renal hospitalization at 12 weeks. A total of 911 patients were randomized and treated. The primary end point occurred in 36.8% and 36.7% of the placebo and nesiritide groups, respectively (hazard ratio, 1.03; 95% confidence interval, 0.82 to 1.3; log-rank test P =0.79). There were no statistically significant differences between groups in any of the secondary end points, including the number of cardiovascular or renal hospitalizations, the number of days alive and out of the hospital, change in Kansas City Cardiomyopathy Questionnaire score, or cardiovascular death. Adverse events were similar between groups; nesiritide was associated with more hypotension but less predefined worsening renal function.
Conclusions— Serial outpatient nesiritide infusions do not provide a demonstrable clinical benefit over intensive outpatient management of patients with advanced American College of Cardiology/American Heart Association stage C/D heart failure.
Received January 17, 2008; accepted February 5, 2008.