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

Abstract

Background The 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 results Adults 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%. Conclusions Patients 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: http://ClinicalTrials.gov Identifier NCT03036124

β-Blocker Doses and Heart Rate in Patients with Heart Failure: Results from the National Norwegian Heart Failure Registry

“…The proportions of the patients in the NYHA functional status groups at stable follow-up compare very well with patients in the recent DAPA-HF study [26].…”

“…Thus, the conservative recommendation in the US guidelines, suboptimal dosing of β-blockers that are consider cornerstone in the treatment in HF, and an effect primarily on HF hospitalisations and not on CV mortality might be contributing factors to the low use of ivabradine. A low use of this drug has also been observed in newer randomised HF trials like the DAPA-HF [25,26], where 5% received ivabradine and in the CHAMP-HF registry where 1% received ivabradine, suggesting that this therapy is generally low in use [26].…”

Dapagliflozin in heart failure: new frontiers

“…6 In the current issue of the Journal, McMurray et al present the baseline characteristics of 4744 patients with HFrEF enrolled in the international, multicentre, parallel group, randomized, double-blind Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) study. 8,9 The authors demonstrate that the population enrolled in DAPA-HF is generally similar compared to other recent trials with ambulant HFrEF, including the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM-HF) trial and the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE). Patients are of similar age compared to the populations of these earlier two trials and the proportion of patients treated with angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitor (94%), beta-blocker (96%), and mineralocorticoid receptor antagonist (71%) is high.…”

“…In the current issue of the Journal, McMurray et al . present the baseline characteristics of 4744 patients with HFrEF enrolled in the international, multicentre, parallel group, randomized, double‐blind Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) study . The authors demonstrate that the population enrolled in DAPA‐HF is generally similar compared to other recent trials with ambulant HFrEF, including the Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM‐HF) trial and the Aliskiren Trial to Minimize Outcomes in Patients with Heart Failure (ATMOSPHERE).…”

November 2019 at a glance. Chronic and acute heart failure: from epidemiology to treatment

“…Sodium–glucose co‐transporter 2 inhibitors improve prognosis of HF patients . McMurray et al . reported the baseline characteristics of patients included in the Dapagliflozin And Prevention of Adverse‐outcomes in Heart Failure (DAPA‐HF) trial.…”