达格列净治疗伴有轻度减少或保留射血分数的心力衰竭：根据药物使用情况分类
Dapagliflozin in Heart Failure With Mildly Reduced or Preserved Ejection Fraction According to Polypharmacy Status.
机构信息
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Division of Cardiology and Division of General Internal Medicine, Department of Medicine, Weill Cornell Medicine, New York, New York, USA.
出版信息
JACC Heart Fail. 2023 Oct;11(10):1380-1393. doi: 10.1016/j.jchf.2023.05.014. Epub 2023 May 21.
BACKGROUND
Patients with heart failure (HF) have a high burden of multimorbidity, often necessitating numerous medications. There may be clinical concern about introducing another medication, especially among individuals with polypharmacy.
OBJECTIVES
This study examined the efficacy and safety of addition of dapagliflozin according to the number of concomitant medications in HF with mildly reduced or preserved ejection fraction.
METHODS
In this post hoc analysis of the DELIVER (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial, 6,263 participants with symptomatic HF with left ventricular ejection fraction >40% were randomized to dapagliflozin or placebo. Baseline medication use (including vitamins and supplements) was collected. Efficacy and safety outcomes were assessed by medication use categories ("nonpolypharmacy": <5 medications; "polypharmacy": 5 to 9 medications; and "hyperpolypharmacy": ≥10 medications) and continuously. The primary outcome was worsening HF or cardiovascular death.
RESULTS
Overall, 3,795 (60.6%) patients met polypharmacy and 1,886 (30.1%) met hyperpolypharmacy criteria. Higher numbers of medications were strongly associated with higher comorbidity burden and increased rates of the primary outcome. Compared with placebo, dapagliflozin similarly reduced the risk of the primary outcome irrespective of polypharmacy status (nonpolypharmacy HR: 0.88 [95% CI: 0.58-1.34]; polypharmacy HR: 0.88 [95% CI: 0.75-1.03]; hyperpolypharmacy HR: 0.73 [95% CI: 0.60-0.88]; P = 0.30). Similarly, benefits with dapagliflozin were consistent across the spectrum of total medication use (P = 0.06). Although adverse events increased with higher number of medications, they were not more frequent with dapagliflozin, regardless of polypharmacy status.
CONCLUSIONS
In the DELIVER trial, dapagliflozin safely reduced worsening HF or cardiovascular death across a broad range of baseline medication use, including among individuals with polypharmacy (Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [DELIVER]; NCT03619213).
背景
心力衰竭（HF）患者存在多种合并症，往往需要服用多种药物。对于合并症较多的患者，引入新的药物可能会引起临床关注。
目的
本研究旨在评估达格列净在射血分数轻度降低或保留的心衰（HF）患者中，根据合并用药数量的不同，添加达格列净的疗效和安全性。
方法
这是 DELIVER 试验（Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure）的事后分析，共纳入 6263 例左心室射血分数>40%、有症状的 HF 患者，随机分为达格列净组或安慰剂组。收集基线用药情况（包括维生素和补充剂）。采用用药类别（“非多药治疗”：<5 种药物；“多药治疗”：5-9 种药物；“超高多药治疗”：≥10 种药物）和连续评估方法评估疗效和安全性结局。主要结局为 HF 恶化或心血管死亡。
结果
总体而言，3795 例（60.6%）患者符合多药治疗标准，1886 例（30.1%）患者符合超高多药治疗标准。用药数量越多，合并症负担越重，主要结局发生率越高。与安慰剂相比，达格列净治疗可显著降低主要结局风险，无论多药治疗状态如何（非多药治疗 HR：0.88 [95%CI：0.58-1.34]；多药治疗 HR：0.88 [95%CI：0.75-1.03]；超高多药治疗 HR：0.73 [95%CI：0.60-0.88]；P=0.30）。同样，达格列净治疗的获益在整个用药范围内一致（P=0.06）。虽然随着用药数量的增加，不良事件的发生率也有所增加，但无论是否使用达格列净，不良事件均无增加。
结论
在 DELIVER 试验中，达格列净在广泛的基线用药情况下，安全地降低了 HF 恶化或心血管死亡风险，包括在多药治疗患者中（Dapagliflozin Evaluation to Improve the Lives of Patients With Preserved Ejection Fraction Heart Failure [DELIVER]；NCT03619213）。
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