Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction Results From the DAPA-HF Trial
Effects of Dapagliflozin on Symptoms, Function, and Quality of Life in Patients With Heart Failure and Reduced Ejection Fraction Results From the DAPA-HF Trial
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DOI：
10.1161/circulationaha.119.044138
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发表时间：
2020-01-14
期刊：
影响因子：
37.8
通讯作者：
McMurray, John J. V.
中科院分区：
文献类型：
--
作者：
Kosiborod, Mikhail N.;Jhund, Pardeep S.;McMurray, John J. V.
背景资料：心力衰竭和射血分数降低患者的管理目标包括减少死亡和住院，改善健康状况（症状、身体功能和生活质量）。在DAPA-HF试验（达格列净和预防心力衰竭不良结局）中，钠-葡萄糖协同转运蛋白-2抑制剂达格列净减少了心力衰竭和射血分数降低患者的死亡和住院率，并改善了症状。在这项分析中，我们使用堪萨斯城心肌病问卷（KCCQ）检查了达格列净对广泛健康状况结局的影响。方法：在随机化、4个月和8个月时评估KCCQ。患者按基线KCCQ总症状评分（TSS）分组;考克斯比例风险模型检查了达格列净对这些亚组临床事件的影响。我们还评估了达格列净对KCCQ-TSS、临床综合评分和总体综合评分的影响。进行应答者分析，以比较达格列净与安慰剂治疗患者在8个月时KCCQ发生具有临床意义变化的比例。结果：共有4443例患者在基线时有可用的KCCQ（中位KCCQ-TSS，77.1 [四分位距，58.3-91.7]）。在KCCQ-TSS范围内，达格列净与安慰剂相比在降低心血管死亡或心力衰竭恶化方面的作用一致（最低至最高三分位数：风险比，0.70 [95% CI，0.57-0.86];风险比，0.77 [95% CI，0.61-0.98];风险比，0.62 [95% CI，0.46-0.83];异质性P =0.52）。接受达格列净治疗的患者在8个月时平均KCCQ-TSS、临床总评分和总体总评分的改善更大（比安慰剂高2.8、2.5和2.3分; P
Background: Goals of management in patients with heart failure and reduced ejection fraction include reducing death and hospitalizations, and improving health status (symptoms, physical function, and quality of life). In the DAPA-HF trial (Dapagliflozin and Prevention of Adverse-Outcomes in Heart Failure), sodium-glucose cotransporter-2 inhibitor, dapagliflozin, reduced death and hospitalizations, and improved symptoms in patients with heart failure and reduced ejection fraction. In this analysis, we examine the effects of dapagliflozin on a broad range of health status outcomes, using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Methods: KCCQ was evaluated at randomization, 4 and 8 months. Patients were divided by baseline KCCQ total symptom score (TSS); Cox proportional hazards models examined the effects of dapagliflozin on clinical events across these subgroups. We also evaluated the effects of dapagliflozin on KCCQ-TSS, clinical summary score, and overall summary score. Responder analyses were performed to compare proportions of dapagliflozin versus placebo-treated patients with clinically meaningful changes in KCCQ at 8 months. Results: A total of 4443 patients had available KCCQ at baseline (median KCCQ-TSS, 77.1 [interquartile range, 58.3-91.7]). The effects of dapagliflozin vs placebo on reducing cardiovascular death or worsening heart failure were consistent across the range of KCCQ-TSS (lowest to highest tertile: hazard ratio, 0.70 [95% CI, 0.57-0.86]; hazard ratio, 0.77 [95% CI, 0.61-0.98]; hazard ratio, 0.62 [95% CI, 0.46-0.83]; P for heterogeneity=0.52). Patients treated with dapagliflozin had greater improvement in mean KCCQ-TSS, clinical summary score, and overall summary score at 8 months (2.8, 2.5 and 2.3 points higher versus placebo; P