Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial.
Empagliflozin, Health Status, and Quality of Life in Patients With Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial.
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DOI：
10.1161/circulationaha.121.057812
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发表时间：
2022-01-18
期刊：
影响因子：
37.8
通讯作者：
Anker SD
中科院分区：
文献类型：
--
作者：
Butler J;Filippatos G;Jamal Siddiqi T;Brueckmann M;Böhm M;Chopra VK;Pedro Ferreira J;Januzzi JL;Kaul S;Piña IL;Ponikowski P;Shah SJ;Senni M;Vedin O;Verma S;Peil B;Pocock SJ;Zannad F;Packer M;Anker SD
补充数字内容可在文本中找到。保留射血分数的心力衰竭患者与健康相关的生活质量有显著的损害。在EMPEROR-Preserved试验（恩帕列净在保留射血分数的慢性心力衰竭患者中的结局试验）中，我们评估了恩帕列净对保留射血分数的心力衰竭患者与健康相关的生活质量的疗效，以及观察到的恩帕列净的临床获益是否根据基线健康状况而变化。在基线、12周、32周和52周使用堪萨斯城心肌病问卷（KCCQ）测量与健康相关的生活质量。根据基线KCCQ临床总结评分（CSS）分位数对患者进行分组，观察恩格列净对预后的影响。评价恩格列净对KCCQ-CSS、总症状评分和总总结评分的影响。对应答者进行分析，比较恩格列净治疗后KCCQ改善和恶化的几率。恩格列净对降低心血管死亡或心力衰竭住院时间的影响在基线KCCQ-CSS分位数中是一致的（风险比分别为0.83 [95% CI, 0.69-1.00]、0.70 [95% CI, 0.55-0.88]和0.82 [95% CI, 0.62-1.08]，对于评分<62.5、62.5 - 83.3和≥83.3，P趋势=0.77）。在心力衰竭住院患者中也看到了类似的结果。与安慰剂相比，接受恩格列净治疗的患者KCCQ-CSS有显著改善（分别在12、32和52周时+1.03、+1.24和+1.50，P<0.01）；总症状评分和总总结评分也有类似的结果。12周时，患者在KCCQ-CSS中改善≥5分（优势比，1.23 [95% CI, 1.10-1.37]）、≥10分（优势比，1.15 [95% CI, 1.03-1.27]）和≥15分（优势比，1.13 [95% CI, 1.02-1.26]）的几率较高（优势比，0.85 [95% CI, 0.75-0.97]），恶化≥5分的几率较低（优势比，0.85 [95% CI, 0.75-0.97]）。在32周和52周观察到类似的模式，总症状评分和总总结评分的结果是一致的。在保留射血分数的心力衰竭患者中，恩格列净在基线KCCQ评分范围内降低了主要心力衰竭结局的风险。恩帕列净改善了与健康相关的生活质量，这种效果出现得较早，并持续了至少1年。URL: https://www.clinicaltrials.gov;唯一标识符：NCT03057951。
Supplemental Digital Content is available in the text. Patients with heart failure with preserved ejection fraction have significant impairment in health-related quality of life. In the EMPEROR-Preserved trial (Empagliflozin Outcome Trial in Patients With Chronic Heart Failure With Preserved Ejection Fraction), we evaluated the efficacy of empagliflozin on health-related quality of life in patients with heart failure with preserved ejection fraction and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Health-related quality of life was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and 12, 32, and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles, and the effect of empagliflozin on outcomes was examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score, and Overall Summary Score was evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. The effect of empagliflozin on reducing the risk of time to cardiovascular death or heart failure hospitalization was consistent across baseline KCCQ-CSS tertiles (hazard ratio, 0.83 [95% CI, 0.69–1.00], 0.70 [95% CI, 0.55–0.88], and 0.82 [95% CI, 0.62–1.08] for scores <62.5, 62.5–83.3, and ≥83.3, respectively; P trend=0.77). Similar results were seen for total heart failure hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24, and +1.50 at 12, 32, and 52 weeks, respectively; P<0.01); similar results were seen for Total Symptom Score and Overall Summary Score. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (odds ratio, 1.23 [95% CI, 1.10–1.37]), ≥10 points (odds ratio, 1.15 [95% CI, 1.03–1.27]), and ≥15 points (odds ratio, 1.13 [95% CI, 1.02–1.26]) and lower odds of deterioration ≥5 points in KCCQ-CSS (odds ratio, 0.85 [95% CI, 0.75–0.97]). A similar pattern was seen at 32 and 52 weeks, and results were consistent for Total Symptom Score and Overall Summary Score. In patients with heart failure with preserved ejection fraction, empagliflozin reduced the risk for major heart failure outcomes across the range of baseline KCCQ scores. Empagliflozin improved health-related quality of life, an effect that appeared early and was sustained for at least 1 year. URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057951.