Efficacy of Dapagliflozin in Black Versus White Patients With Heart Failure and Reduced Ejection Fraction,JACC: Heart Failure

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Efficacy of Dapagliflozin in Black Versus White Patients With Heart Failure and Reduced Ejection Fraction
JACC: Heart Failure ( IF 10.3 ) Pub Date : 2021-11-10 , DOI: 10.1016/j.jchf.2021.08.006
Kieran F Docherty ₁ , Modele O Ogunniyi ₂ , Inder S Anand ₃ , Akshay S Desai ₄ , Mirta Diez ₅ , Jonathan G Howlett ₆ , Jose C Nicolau ₇ , Eileen O'Meara ₈ , Subodh Verma ₉ , Silvio E Inzucchi ₁₀ , Lars Køber ₁₁ , Mikhail N Kosiborod ₁₂ , Daniel Lindholm ₁₃ , Felipe A Martinez ₁₄ , Olof Bengtsson ₁₃ , Piotr Ponikowski ₁₅ , Marc S Sabatine ₁₆ , Mikaela Sjöstrand ₁₃ , Scott D Solomon ₄ , Anna Maria Langkilde ₁₃ , Pardeep S Jhund ₁ , John J V McMurray ₁

Affiliation

British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.
Division of Cardiology, Emory University School of Medicine, Atlanta, Georgia, USA.
Department of Medicine, University of Minnesota Medical School and VA Medical Center, Minneapolis, Minnesota, USA.
Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Division of Cardiology, Institute Cardiovascular de Buenos Aires, Buenos Aires, Argentina.
University of Calgary, Cardiac Sciences and Medicine, Calgary, Alberta, Canada.
Instituto do Coracao, Hospital das Clínicas Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil.
Deparment of Cardiology, Institute of Cardiology Montreal, Montreal, Montreal, Canada.
Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut, USA.
Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.
Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA.
AstraZeneca, Gothenburg, Sweden.
National University of Cordoba, Cordoba, Argentina.
Wroclaw Medical University, Wroclaw, Poland.
TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.

Objectives

This study sought to investigate the efficacy and safety of dapagliflozin in Black and White patients with heart failure (HF) with reduced ejection fraction (HFrEF) enrolled in 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).

Background

Black patients may respond differently to certain treatments for HFrEF than White patients.

Methods

Patients with New York Heart Association functional class II to IV with an ejection fraction of ≤40% and elevated N-terminal pro–B-type natriuretic peptide were eligible for DAPA-HF. Because >99% of Black patients were randomized in the Americas, this post hoc analysis considered Black and White patients enrolled only in North and South America. The primary outcome was the composite of a worsening HF event (HF hospitalization or urgent HF visit requiring intravenous therapy) or cardiovascular death.

Results

Of the 4,744 patients randomized in DAPA-HF, 1,494 (31.5%) were enrolled in the Americas. Of these, 1,181 (79.0%) were White, and 225 (15.1%) were Black. Black patients had a higher rate of worsening HF events, but not mortality, compared with White patients. Compared with placebo, dapagliflozin reduced the risk of the primary endpoint similarly in Black patients (HR: 0.62; 95% CI: 0.37-1.03) and White patients (HR: 0.68; 95% CI: 0.52-0.90; P-interaction = 0.70). Consistent benefits were observed for other prespecified outcomes, including the composite of total (first and repeat) HF hospitalizations and cardiovascular death (P-interaction = 0.43) and Kansas City Cardiomyopathy Questionnaire total symptom score. Study drug discontinuation and serious adverse events were not more frequent in the dapagliflozin group than in the placebo group in either Black or White patients.

Conclusions

Dapagliflozin reduced the risk of worsening HF and cardiovascular death, and it improved symptoms, similarly in Black and White patients without an increase in adverse events. (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure [DAPA-HF]; NCT03036124)

中文翻译：

达格列净在心力衰竭和射血分数降低的黑人与白人患者中的疗效

目标

本研究旨在调查 DAPA-HF（评估达格列净对心力衰竭恶化或慢性心力衰竭患者的心血管死亡）。

背景

黑人患者对 HFrEF 某些治疗的反应可能与白人患者不同。

方法

纽约心脏协会功能分级 II 至 IV 且射血分数≤40% 且 N 末端 B 型利钠肽升高的患者符合 DAPA-HF 的条件。因为 > 99% 的黑人患者在美洲被随机分配，所以这项事后分析考虑了仅在北美和南美招募的黑人和白人患者。主要结局是心衰事件恶化（心衰住院或需要静脉治疗的心衰紧急就诊）或心血管死亡的复合结局。

结果

在 DAPA-HF 随机分组的 4,744 名患者中，有 1,494 名（31.5%）被纳入美洲。其中，1181 人（79.0%）是白人，225 人（15.1%）是黑人。与白人患者相比，黑人患者的 HF 事件恶化率较高，但死亡率不高。与安慰剂相比，达格列净在黑人患者（HR：0.62；95% CI：0.37-1.03）和白人患者（HR：0.68；95% CI：0.52-0.90；P -interaction = 0.70 ）中同样降低了主要终点的风险）。其他预先设定的结局也观察到了一致的益处，包括总（第一次和重复）心衰住院和心血管死亡的复合（P-interaction = 0.43) 和堪萨斯城心肌病问卷总症状评分。在黑人或白人患者中，达格列净组的研究药物停药和严重不良事件的发生率并不高于安慰剂组。