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The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial: baseline characteristics
John J V McMurray1, David L DeMets2, Silvio E Inzucchi3
1BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Insights
The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial enrolled patients with heart failure (HF) similar to other trials. Patients with diabetes had worse HF status but received comparable therapy, enabling efficacy testing of dapagliflozin.
Area of Science:
- Cardiology
- Endocrinology
- Clinical Trials
Background:
- The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial investigates dapagliflozin in patients with heart failure (HF).
- Baseline characteristics of DAPA-HF participants were analyzed and compared to contemporary HF registries and trials.
- Subgroup analysis focused on patients with diabetes, pre-diabetes, and normal glycated haemoglobin (HbA1c) levels within the DAPA-HF cohort.
Purpose of the Study:
- To report baseline characteristics of patients in the DAPA-HF trial.
- To compare DAPA-HF participants with patients in other heart failure registries and trials.
- To compare outcomes among patients with diabetes, pre-diabetes, and normal HbA1c within the DAPA-HF study.
Main Methods:
- Adults with heart failure (HF) meeting specific criteria (NYHA class ≥II, LVEF ≤40%, elevated NT-proBNP) were randomized to dapagliflozin or placebo.
- Diabetes was defined by HbA1c ≥6.5%, pre-diabetes by HbA1c 5.7%-6.4%, and normoglycemia by HbA1c <5.7%.
- Patient demographics, comorbidities, renal function, and background HF and glucose-lowering therapies were recorded.
Main Results:
- 4744 patients (mean age 66 years, 23% women) were randomized; 45% had diabetes (42% known, 3% undiagnosed).
- Of the remaining patients, 67% had pre-diabetes and 33% were normoglycemic.
- DAPA-HF patients generally resembled those in other HF registries/trials, with high rates of guideline-directed medical therapy. Patients with diabetes exhibited worse HF status, more comorbidities, and greater renal impairment but received similar HF therapies.
Conclusions:
- Patients in the DAPA-HF trial are representative of contemporary patients with heart failure with reduced ejection fraction (HFrEF).
- Participants with diabetes were treated with conventional glucose-lowering therapies, similar to the overall HFrEF population.
- The DAPA-HF trial is well-positioned to evaluate the efficacy and safety of dapagliflozin in HFrEF patients, both with and without diabetes.
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:
ClinicalTrials.gov Identifier NCT03036124.
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