Heart failure & cardiomyopathies

Influence of Background Medical Therapy on Efficacy and Safety of Dapagliflozin in Patients with Heart Failure with Improved Ejection Fraction in the DELIVER Trial

Eur J Heart FailPublished Secondary analysis of the DELIVER randomised trial

Authors' conclusion

In patients with HFimpEF, the safety and efficacy of dapagliflozin were largely similar by background use and dosing of HF medical therapies. The benefit of dapagliflozin in reducing HF events tended to be greater in those patients on 0-1 medications at baseline. Among patients already on three HF medical therapies, the addition of dapagliflozin was safe without requiring de-escalation of other therapies.

Study context

Population
Patients with symptomatic heart failure (HF) with improved EF (HFimpEF; prior LVEF ≤40% improved to >40% by enrolment) in DELIVERHFimpEF of 6263 randomized
Participants
1,151 patients
Comparison
Dapagliflozin vs placebo, by number of background HF medical therapies
Primary endpoint
Worsening HF or CV death
Follow-up
Median 2.3 years

Primary result

As reported in the abstract

Primary outcome by number of background HF therapies · median 2.3 years

Primary outcome by number of background HF therapies · median 2.3 years

Proportion of patients 0-1 therapies 21% · 2 therapies 44% · 3 therapies 35%

Dapagliflozin effect on primary outcome may be greater on 0-1 therapies
P for interaction = 0.09
Interaction for HF hospitalization (significant)
P for interaction = 0.023
No effect modification for CV death
P for interaction = 0.65
Consistent effect across modified Heart Failure Collaboratory Medical Therapy Score
P for interaction = 0.39

Further findings

Dapagliflozin not associated with changes in use or doses of background HF therapies

Safety

Adverse events in patients on 3 HF medications

Addition of dapagliflozin did not lead to higher adverse events

Original publication

Influence of Background Medical Therapy on Efficacy and Safety of Dapagliflozin in Patients with Heart Failure with Improved Ejection Fraction in the DELIVER Trial. Eur J Heart Fail. Published 29 August 2023. doi:10.1002/ejhf.3001

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