Department of Pharmacy Practice, Lipscomb University College of Pharmacy, Nashville, Tennessee, USA; Department of Pharmacy, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Veterans Affairs Tennessee Valley Healthcare System, Geriatric Research, Education and Clinical Center, Nashville, Tennessee, USA.
J Am Coll Cardiol. 2024 Apr 9;83(14):1295-1306. doi: 10.1016/j.jacc.2024.02.009.
The primary goals during acute heart failure (AHF) hospitalization are decongestion and guideline-directed medical therapy (GDMT) optimization. Unlike diuretics or other GDMT, early dapagliflozin initiation could achieve both AHF goals.
The authors aimed to assess the diuretic efficacy and safety of early dapagliflozin initiation in AHF.
In a multicenter, open-label study, 240 patients were randomized within 24 hours of hospital presentation for hypervolemic AHF to dapagliflozin 10 mg once daily or structured usual care with protocolized diuretic titration until day 5 or hospital discharge. The primary outcome, diuretic efficiency expressed as cumulative weight change per cumulative loop diuretic dose, was compared across treatment assignment using a proportional odds model adjusted for baseline weight. Secondary and safety outcomes were adjudicated by a blinded committee.
For diuretic efficiency, there was no difference between dapagliflozin and usual care (OR: 0.65; 95% CI: 0.41-1.02; P = 0.06). Dapagliflozin was associated with reduced loop diuretic doses (560 mg [Q1-Q3: 260-1,150 mg] vs 800 mg [Q1-Q3: 380-1,715 mg]; P = 0.006) and fewer intravenous diuretic up-titrations (P ≤ 0.05) to achieve equivalent weight loss as usual care. Early dapagliflozin initiation did not increase diabetic, renal, or cardiovascular safety events. Dapagliflozin was associated with improved median 24-hour natriuresis (P = 0.03) and urine output (P = 0.005), expediting hospital discharge over the study period.
Early dapagliflozin during AHF hospitalization is safe and fulfills a component of GDMT optimization. Dapagliflozin was not associated with a statistically significant reduction in weight-based diuretic efficiency but was associated with evidence for enhanced diuresis among patients with AHF. (Efficacy and Safety of Dapagliflozin in Acute Heart Failure [DICTATE-AHF]; NCT04298229).
急性心力衰竭（AHF）住院期间的主要目标是消除充血和优化指南指导的药物治疗（GDMT）。与利尿剂或其他 GDMT 不同，早期达格列净的应用可同时实现这两个目标。
作者旨在评估早期达格列净在 AHF 中的利尿效果和安全性。
在一项多中心、开放标签研究中，240 例入院时存在高血容量性 AHF 的患者在入院后 24 小时内随机接受达格列净 10mg 每日一次或常规护理加方案化利尿剂滴定，直至第 5 天或出院。主要结局是通过比例优势模型（根据基线体重调整）比较两种治疗方法的累积利尿效率，累积利尿效率表示为单位累积袢利尿剂剂量的体重减轻量。次要结局和安全性结局由盲法委员会判定。
在利尿效率方面，达格列净与常规护理之间无差异（OR：0.65；95%CI：0.41-1.02；P=0.06）。与常规护理相比，达格列净可减少袢利尿剂剂量（560mg[Q1-Q3：260-1150mg]vs 800mg[Q1-Q3：380-1715mg]；P=0.006），且达到与常规护理相同的体重减轻效果时需要较少的静脉利尿剂升级（P≤0.05）。早期达格列净的应用并未增加糖尿病、肾脏或心血管安全性事件。达格列净可改善 24 小时平均钠排泄（P=0.03）和尿量（P=0.005），从而加速患者在研究期间出院。
AHF 住院期间早期应用达格列净安全且符合 GDMT 优化的一部分。达格列净与基于体重的利尿效率的统计学显著降低无关，但与 AHF 患者的利尿增强有关。（Efficacy and Safety of Dapagliflozin in Acute Heart Failure [DICTATE-AHF]；NCT04298229）。
