Siddiqi Tariq Jamal, Anker Stefan D, Filippatos Gerasimos, Ferreira João Pedro, Pocock Stuart J, Böhm Michael, Brueckmann Martina, Chopra Vijay K, Iwata Tomoko, Januzzi James, Piña Ileana L, Ponikowski Piotr, Senni Michele, Vedin Ola, Verma Subodh, Zhang Yuhui, Zannad Faiez, Packer Milton, Butler Javed
Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.
Department of Cardiology and Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany.
Eur J Heart Fail. 2023 Sep;25(9):1623-1631. doi: 10.1002/ejhf.2831. Epub 2023 Apr 4.
There are limited data on health status and changes in it over time across major subgroups of patients with heart failure and preserved ejection fraction (HFpEF), including ejection fraction spectrum, age, sex, region, body mass index (BMI), and comorbidities including diabetes, chronic kidney disease (CKD), anaemia, and atrial fibrillation/flutter.
In the EMPEROR-Preserved trial, the Kansas City Cardiomyopathy Questionnaire (KCCQ) was assessed at baseline, 12, 32 and 52 weeks. Determinants of baseline KCCQ score and change over time, and the impact of empagliflozin on KCCQ scores were studied in specified subgroups. A Cox model was used to assess the association between 5- and 10-point increase and 5-point decrease in KCCQ score from baseline to week 12 and later outcomes. Among 2979 participants in the placebo arm, mean KCCQ clinical summary score (CSS) was 70.7 (20.8). Older age, female sex, BMI, anaemia, and a history of diabetes, and CKD were associated with worse scores. KCCQ-CSS score improved during follow-up; patients with atrial fibrillation/flutter at enrollment (p trend = 0.014) and CKD (p trend < 0.001) had less improvement. A 5-point increase in KCCQ-CSS at week 12 was associated with lower risk of cardiovascular death or heart failure hospitalization (5%), cardiovascular death (8%), and first heart failure hospitalization (4%) subsequently. A similar trend was seen with KCCQ total symptom score (TSS) and overall summary score (OSS). Empagliflozin improved KCCQ-CSS, -TSS and -OSS scores similarly across subgroups studied except for greater improvement in patients with the highest BMI (p trend = 0.153, 0.08 and 0.078, respectively).
Health status in patients with HFpEF is impaired, especially in elderly, women, and those with obesity and comorbidities. Empagliflozin improved health status among all key subgroups studied with a greater effect in obese patients.
关于射血分数保留的心力衰竭（HFpEF）患者的主要亚组，包括射血分数范围、年龄、性别、地区、体重指数（BMI）以及合并症（包括糖尿病、慢性肾脏病[CKD]、贫血和心房颤动/扑动）的健康状况及其随时间的变化，相关数据有限。
在EMPEROR-Preserved试验中，于基线、12周、32周和52周时评估堪萨斯城心肌病问卷（KCCQ）。在特定亚组中研究了基线KCCQ评分及其随时间变化的决定因素，以及恩格列净对KCCQ评分的影响。使用Cox模型评估从基线到第12周KCCQ评分增加5分和10分以及降低5分与后续结局之间的关联。在安慰剂组的2979名参与者中，KCCQ临床总结评分（CSS）的平均值为70.7（20.8）。年龄较大、女性、BMI、贫血以及糖尿病和CKD病史与较差的评分相关。随访期间KCCQ-CSS评分有所改善；入组时患有心房颤动/扑动（p趋势=0.014）和CKD（p趋势<0.001）的患者改善较少。第12周时KCCQ-CSS增加5分与随后心血管死亡或心力衰竭住院风险降低（5%）以及心血管死亡风险降低（8%）和首次心力衰竭住院风险降低（4%）相关。KCCQ总症状评分（TSS）和总体总结评分（OSS）也呈现类似趋势。除BMI最高的患者改善更大外（p趋势分别为0.153、0.08和0.078），恩格列净在各研究亚组中对KCCQ-CSS、-TSS和-OSS评分的改善相似。
HFpEF患者的健康状况受损，尤其是老年人、女性以及患有肥胖症和合并症的患者。恩格列净改善了所有研究的关键亚组的健康状况，对肥胖患者的效果更佳。
