JACC: Heart Failure ( IF 10.3 ) Pub Date : 2020-07-08 , DOI: 10.1016/j.jchf.2020.04.008 Scott D Solomon 1 , Pardeep S Jhund 2 , Brian L Claggett 1 , Pooja Dewan 2 , Lars Køber 3 , Mikhail N Kosiborod 4 , Felipe A Martinez 5 , Piotr Ponikowski 6 , Marc S Sabatine 7 , Silvio E Inzucchi 8 , Akshay S Desai 1 , Olof Bengtsson 9 , Daniel Lindholm 8 , Mikaela Sjostrand 1 , Anna Maria Langkilde 9 , John J V McMurray 2
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Objectives
This study assessed the efficacy and safety of dapagliflozin in patients who were or were not taking sacubitril/valsartan at baseline in the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial.
Background
Both the angiotensin receptor neprilysin-inhibitor sacubitril/valsartan and the sodium glucose co-transporter 2 inhibitor dapagliflozin reduced cardiovascular death and heart failure (HF) hospitalization in patients with HF with reduced ejection fraction (HFrEF). Whether either of these classes of drugs influences the effectiveness or safety of the other remains unknown.
Methods
DAPA-HF was a 4,744 patient trial that compared dapagliflozin with placebo in patients with HFrEF. Patients were analyzed according to whether they were taking sacubitril/valsartan at randomization. The efficacy of dapagliflozin on the primary composite outcome (CV death or episode of worsening heart failure), its components, and all-cause death was examined according to sacubitril/valsartan and the interaction tested. Predefined safety outcomes were examined by sacubitril/valsartan group.
Results
A total of 508 patients (10.7%) enrolled in DAPA-HF were treated with sacubitril/valsartan at baseline. Patients prescribed sacubitril/valsartan were more likely to be from North America or Europe, to have lower ejection fractions and systolic and diastolic blood pressures, but were similar with respect to age, New York Heart Association functional class, history of diabetes, and use of other evidence-based HF therapies. The benefit of dapagliflozin compared with placebo was similar in patients taking sacubitril/valsartan (hazard ratio: 0.75; 95% confidence interval 0.50 to 1.13) compared with those not taking sacubitril/valsartan (hazard ratio: 0.74; 95% confidence interval 0.65 to 0.86) for the primary endpoint of cardiovascular death or worsening HF; similar findings were observed for secondary endpoints. All measures of safety, including episodes related to hypovolemia, were similar among patients randomized to dapagliflozin or placebo, whether they received background sacubitril/valsartan.
Conclusions
Dapagliflozin was similarly efficacious and safe in patients who were and who were not taking sacubitril/valsartan in the DAPA-HF trial, which suggested that the use of both agents together could further lower morbidity and mortality in patients with HFrEF. (Dapagliflozin And Prevention of Adverse outcomes in Heart Failure [DAPA-HF]; NCT03036124)
中文翻译：
达格列净对接受沙库巴曲/缬沙坦治疗的 HFrEF 患者的影响：DAPA-HF 试验。
目标
本研究评估了达格列净对 DAPA-HF 中基线时服用或未服用沙库巴曲/缬沙坦的患者的疗效和安全性（评估达格列净对慢性心脏病患者心力衰竭或心血管死亡发生率的影响的研究）失败）审判。
背景
血管紧张素受体脑啡肽酶抑制剂沙库巴曲/缬沙坦和钠葡萄糖协同转运蛋白 2 抑制剂达格列净均降低了射血分数降低 (HFrEF) HF 患者的心血管死亡和心力衰竭 (HF) 住院率。这两类药物中的任何一种是否会影响另一种药物的有效性或安全性仍然未知。
方法
DAPA-HF 是一项涉及 4,744 名患者的试验，该试验在 HFrEF 患者中比较了达格列净与安慰剂。根据随机分组时患者是否服用沙库巴曲/缬沙坦对患者进行分析。根据沙库巴曲/缬沙坦和相互作用测试，检查了达格列净对主要复合结局（心血管死亡或心力衰竭恶化发作）、其成分和全因死亡的疗效。沙库巴曲/缬沙坦组检查了预先确定的安全性结果。
结果
共有 508 名患者 (10.7%) 参加了 DAPA-HF，在基线时接受了沙库巴曲/缬沙坦治疗。服用沙库巴曲/缬沙坦的患者更有可能来自北美或欧洲，射血分数和收缩压和舒张压较低，但在年龄、纽约心脏协会功能分级、糖尿病史和使用其他循证 HF 疗法。与未服用沙库巴曲/缬沙坦的患者相比，服用沙库巴曲/缬沙坦的患者（风险比：0.75；95% 置信区间 0.50 至 1.13）与达格列净相比安慰剂的益处相似（风险比：0.74；95% 置信区间 0.65 至 0.86） ) 心血管死亡或心衰恶化的主要终点；次要终点也观察到了类似的结果。一切安全措施，
结论
在 DAPA-HF 试验中，达格列净对服用和未服用沙库巴曲/缬沙坦的患者同样有效和安全，这表明两种药物一起使用可以进一步降低 HFrEF 患者的发病率和死亡率。（达格列净和心力衰竭不良结局的预防 [DAPA-HF]；NCT03036124）
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