Health-Related Quality of Life Outcomes in PARADIGM-HF
Health-Related Quality of Life Outcomes in PARADIGM-HF
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DOI：
10.1161/circheartfailure.116.003430
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发表时间：
2017-08-01
影响因子：
9.7
通讯作者：
Swedberg, Karl
中科院分区：
文献类型：
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作者：
Lewis, Eldrin F.;Claggett, Brian L.;Swedberg, Karl
背景 射血分数降低的心力衰竭患者的健康相关生活质量 (HRQL) 受损，对针对死亡率和心力衰竭住院治疗的治疗反应各异。在 PARADIGM-HF 试验（ARNI [血管紧张素受体脑啡肽酶抑制剂] 与 ACEI [血管紧张素转换酶抑制剂] 的前瞻性比较以确定对心力衰竭总体死亡率和发病率的影响）中，与依那普利相比，沙库巴曲/缬沙坦降低了发病率和死亡率。另一个主要治疗目标是改善 HRQL。鉴于沙库巴曲/缬沙坦可改善死亡率，本分析仅对幸存者的 HRQL 治疗影响进行全面评估。 方法和结果 患者（磨合期后）使用堪萨斯城心肌病问卷 (KCCQ) 在随机、第 4 个月、第 8 个月和每年就诊时完成了疾病特异性 HRQL。 KCCQ 评分的变化是使用协方差模型的重复测量分析来计算的，该模型根据治疗和基线值进行调整（预先指定 8 个月时的主要疗效）。在参加 PARADIGM-HF 的 8399 名患者中，7623 名患者（91%）在随机分组时完成了 KCCQ 评分，其中 6881 名患者（基线的 90%）在 8 个月时获得了完整数据。 8 个月时，沙库巴曲/缬沙坦组注意到 KCCQ 临床总结评分（+0.64 对比 -0.29；P=0.008）和 KCCQ 总体总结评分（+1.13 对比 -0.14；P
Background Patients with heart failure and reduced ejection fraction have impaired health-related quality of life (HRQL) with variable responses to therapies that target mortality and heart failure hospitalizations. In PARADIGM-HF trial (Prospective Comparison of ARNI [Angiotensin Receptor-Neprilysin Inhibitor] With ACEI [Angiotensin-Converting-Enzyme Inhibitor] to Determine Impact on Global Mortality and Morbidity in Heart Failure), sacubitril/valsartan reduced morbidity and mortality compared with enalapril. Another major treatment goal is to improve HRQL. Given improvements in mortality with sacubitril/valsartan, this analysis provides comprehensive assessment of impact of therapy on HRQL in survivors only.Methods and Results Patients (after run-in phase) completed disease-specific HRQL using Kansas City Cardiomyopathy Questionnaire (KCCQ) at randomization, 4 month, 8 month, and annual visits. Changes in KCCQ scores were calculated using repeated measures analysis of covariance model that adjusted for treatment and baseline values (principal efficacy prespecified at 8 months). Among the 8399 patients enrolled in PARADIGM-HF, 7623 (91%) completed KCCQ scores at randomization with complete data at 8 months for 6881 patients (90% of baseline). At 8 months, sacubitril/valsartan group noted improvements in both KCCQ clinical summary score (+0.64 versus -0.29; P=0.008) and KCCQ overall summary score (+1.13 versus -0.14; P