The Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) trial: baseline characteristics

European Journal of Heart Failure - Tập 21 Số 11 - Trang 1402-1411 - 2019
John J.V. McMurray1, David L. DeMets2, Silvio E. Inzucchi3, Lars Køber4, Mikhail Kosiborod5, Anna Maria Langkilde6, Felipe A. Martínez7, Olof Bengtsson6, Piotr Ponikowski8, Marc S. Sabatine9, Mikaela Sjöstrand6, Scott D. Solomon10
1BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK
2Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI USA
3Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA
4Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
5Saint Luke’s Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA
6BioPharmaceuticals R&D, AstraZeneca Gothenburg Sweden
7National University of Cordoba, Cordoba, Argentina
8Wroclaw Medical University, Wroclaw, Poland
9TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
10Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA

Tóm tắt

BackgroundThe aims of this study were to: (i) report the baseline characteristics of patients enrolled in the Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) trial, (ii) compare DAPA‐HF patients to participants in contemporary heart failure (HF) registries and in other recent HF trials, and (iii) compare individuals with diabetes, pre‐diabetes and a normal glycated haemoglobin (HbA1c) in DAPA‐HF.Methods and resultsAdults with HF in New York Heart Association functional class ≥ II, a left ventricular ejection fraction ≤ 40%, an elevated N‐terminal pro‐B‐type natriuretic peptide concentration and receiving standard treatment were eligible for DAPA‐HF, which is comparing dapagliflozin 10 mg once daily to matching placebo. In patients without a history of diabetes, previously undiagnosed diabetes was defined as a confirmed HbA1c ≥ 6.5%. Among patients without known or undiagnosed diabetes, pre‐diabetes was defined as a HbA1c ≥ 5.7% The remainder of patients, with a HbA1c < 5.7%, were defined as normoglycaemic. Of the 4744 patients (mean age 66 years; 23% women) randomized, 42% had known diabetes and 3% undiagnosed diabetes. Of the remainder, 67% had pre‐diabetes and 33% normal HbA1c. Overall, DAPA‐HF patients were generally similar to those in recent registries and in relevant trials and had high levels of background therapy: 94% angiotensin‐converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor–neprilysin inhibitor, 96% beta‐blocker, and 71% mineralocorticoid receptor antagonist; 26% had a defibrillator. Patients with diabetes had worse HF status, more co‐morbidity, and greater renal impairment but received similar HF therapy. Patients with diabetes received non‐insulin hypoglycaemic therapy alone in 49%, insulin alone in 11%, both in 14%, and none in 26%.ConclusionsPatients randomized in DAPA‐HF were similar to those in other contemporary HF with reduced ejection fraction (HFrEF) registries and trials. These patients were receiving recommended HFrEF therapy and those with diabetes were also treated with conventional glucose‐lowering therapy. Consequently, DAPA‐HF will test the incremental efficacy and safety of dapagliflozin in HFrEF patients with and without diabetes.Clinical Trial Registration: ClinicalTrials.gov Identifier NCT03036124

Từ khóa


Tài liệu tham khảo

10.1056/NEJMoa1504720

10.1056/NEJMoa1611925

10.1056/NEJMoa1812389

10.1001/jamacardio.2017.2275

10.1007/s00125-018-4670-7

10.1016/j.jacc.2018.06.040

10.1161/CIRCULATIONAHA.118.035759

10.1161/CIRCULATIONAHA.117.030012

10.1056/NEJMoa1515920

10.1002/ejhf.1432

10.1002/ejhf.813

10.1093/eurjhf/hft134

10.1161/CIRCOUTCOMES.118.004668

10.1016/j.jacc.2018.04.070

10.1093/eurheartj/ehw331

10.1002/ejhf.1358

10.1016/S2214-109X(18)30306-1

10.1056/NEJMoa1409077

10.1056/NEJMoa1514859

10.1016/S0140-6736(10)61198-1

10.1056/NEJMoa1808848

10.1002/ejhf.933

10.1002/ejhf.896

10.1136/bmj.h4451

10.1001/jama.2016.18533

10.1161/CIRCHEARTFAILURE.115.002560

10.1161/JAHA.116.005156

10.1093/eurjhf/hfq167

10.1161/JAHA.118.009237

10.1016/S2213-8587(17)30087-6

10.1002/ejhf.347

10.2337/dc16-2016

10.1111/dom.13511

10.1056/NEJMoa1203858

10.1093/eurjhf/hfs153

10.1177/1479164116637311

10.1016/j.ahj.2018.05.016

10.1002/ejhf.1170

Thông tin
Thông tin xuất bản

European Journal of Heart Failure

Tập 21 Số 11

1402-1411

Thông tin tác giả