Sacubitril/valsartan and Quality of Life Assessed Using the EuroQol 5-Dimension 3-Level Questionnaire Level Sum Score (EQ-5D-3L-LSS) in Patients with HFrEF and HFmrEF/HFpEF.

IF 6.1 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

European Heart Journal - Cardiovascular Pharmacotherapy Pub Date : 2025-08-21 DOI:10.1093/ehjcvp/pvaf064

Mingming Yang, Alasdair D Henderson, Inder S Anand, Akshay S Desai, Carolyn S P Lam, Aldo P Maggioni, Felipe A Martinez, Jean L Rouleau, Karl Swedberg, Muthiah Vaduganathan, Dirk J van Veldhuisen, Faiez Zannad, Michael R Zile, Milton Packer, Adel Rizkala, Eldrin F Lewis, Pardeep S Jhund, Scott D Solomon, John J V McMurray

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引用次数: 0

Abstract

Objectives: To investigate the EQ-5D-3L Level Sum Score (LSS) in patients with heart failure (HF) and reduced (HFrEF) and mildly reduced or preserved ejection fraction (HFmrEF/HFpEF) and the effect of sacubitril/valsartan on this score using patient-level data from the PARADIGM-HF and PARAGON-HF trials.

Methods: The LSS was calculated by summating the 3 levels (1-3) for each of the 5 domains (minimum sum score=5; maximum sum score=15). Patient characteristics and outcomes were compared across LSS tertiles (T1-T3) at baseline. Cox models were used to evaluate the primary endpoint (first HF hospitalization or cardiovascular death) according to tertiles of LSS. Changes in LSS severity at 8 months were analysed using ordinal logistic regression models to estimate the effect of sacubitril/valsartan versus enalapril or valsartan.

Results: Of 13,195 patients, 12,974 had a baseline LSS. Compared to lower LSS, patients with higher (worse) scores were older, more often women and White, and had more comorbidities and more severe HF. At 8 months, patients assigned to sacubitril/valsartan experienced more improvement and less worsening of LSS versus the comparator: OR:1.16 (95%CI: 1.08-1.24). Sacubitril/valsartan also reduced the risk of the primary outcome across LSS tertiles: T1: HR: 0.87 (95%CI: 0.75-1.00); T2: 0.80 (95%CI: 0.71-0.90); T3: 0.87 (95%CI: 0.77-0.97); Pinteraction=0.59. Higher LSS was independently associated with a greater risk of the primary endpoint, and the achieved LSS at 8 months may be more strongly associated with subsequent outcomes.

Conclusions: Sacubitril/valsartan significantly reduced the risk of HF events and improved health status across the LSS spectrum in HFrEF and HFmrEF/HFpEF.

Clinical trial registration: https://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).

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使用EuroQol 5维3级问卷水平和评分（EQ-5D-3L-LSS）评估subbitril /缬沙坦与HFrEF和HFmrEF/HFpEF患者的生活质量

目的：利用PARADIGM-HF和PARAGON-HF试验的患者水平数据，研究心力衰竭（HF）和降低（HFrEF）、轻度降低或保留射血分数（HFmrEF/HFpEF）患者的EQ-5D-3L水平总评分（LSS），以及苏比里尔/缬沙坦对该评分的影响。方法：将5个域的3个等级（1-3）相加计算LSS（最小和分=5，最大和分=15）。在基线时比较LSS各组（T1-T3）的患者特征和结果。根据LSS的分位数，采用Cox模型评估主要终点（首次HF住院或心血管死亡）。使用有序逻辑回归模型分析8个月时LSS严重程度的变化，以评估sacubitril/缬沙坦与依那普利或缬沙坦的效果。结果：13,195例患者中，12,974例基线LSS。与LSS较低的患者相比，评分较高（较差）的患者年龄较大，多为女性和白人，并且有更多的合并症和更严重的HF。在8个月时，与比较组相比，分配给sacubitril/缬沙坦的患者LSS改善更多，恶化更少：OR:1.16 （95%CI: 1.08-1.24）。Sacubitril/缬沙坦也降低了LSS各组主要结局的风险：T1: HR: 0.87 (95%CI: 0.75-1.00)；T2: 0.80 (95%ci: 0.71-0.90)；T3: 0.87 (95%ci: 0.77-0.97)；Pinteraction = 0.59。较高的LSS与较高的主要终点风险独立相关，并且在8个月时达到的LSS可能与随后的结果有更强的相关性。结论：Sacubitril/缬沙坦可显著降低HF事件的风险，并改善HFrEF和HFmrEF/HFpEF患者LSS谱的健康状况。临床试验注册：https://www.clinicaltrials.gov。唯一标识符：NCT01920711 (PARAGON-HF), NCT01035255 （PARADIGM-HF）。

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来源期刊

European Heart Journal - Cardiovascular Pharmacotherapy Medicine-Cardiology and Cardiovascular Medicine

CiteScore

10.10

自引率

14.10%

发文量

期刊介绍： The European Heart Journal - Cardiovascular Pharmacotherapy (EHJ-CVP) is an international, peer-reviewed journal published in English, specifically dedicated to clinical cardiovascular pharmacology. EHJ-CVP publishes original articles focusing on clinical research involving both new and established drugs and methods, along with meta-analyses and topical reviews. The journal's primary aim is to enhance the pharmacological treatment of patients with cardiovascular disease by interpreting and integrating new scientific developments in this field. While the emphasis is on clinical topics, EHJ-CVP also considers basic research articles from fields such as physiology and molecular biology that contribute to the understanding of cardiovascular drug therapy. These may include articles related to new drug development and evaluation, the physiological and pharmacological basis of drug action, metabolism, drug interactions, and side effects.