Methods:
This is a prespecified analysis of the DELIVER (Dapagliflozin Evaluation to Improve
Health Status With Dapagliflozin in HF With
Mildly Reduced or Preserved EF
Jan 31, 2023
Authors: Kosiborod MN, Bhatt AS, Claggett BL, et al.
Citation: Effect of Dapagliflozin on Health Status in
Patients With Preserved or Mildly Reduced
Ejection Fraction. J Am Coll Cardiol 2023;81:460-
473. 
Summary By: Supriya Shore, MD
Quick Takes
The effect of dapagliflozin in reducing CV death or worsening HF was more
pronounced in patients with higher baseline symptom burden with an EF
>40%.
Dapagliflozin use was associated with an improvement in health status in
HF patients with EF >40% as early as 1 month.
Improvement in health status with dapagliflozin was consistent across all
subgroups with EF >40%.
Study Questions:
What is the effect of dapagliflozin on health status in patients with heart failure
(HF) with mildly reduced or preserved ejection fraction (EF), and do they vary
based on extent of baseline symptom impairment?
the Lives of Patients With Preserved Ejection Fraction Heart Failure) trial, which
compared efficacy of dapagliflozin to placebo in patients with HF and mildly
reduced or preserved EF. Adults >40 years old, with an EF >40%, New York Heart
Association class II-IV symptoms, and elevated B-type natriuretic peptide were
enrolled. The primary outcome was a composite of cardiovascular (CV) death or
worsening HF. The secondary endpoint was change in Kansas City Cardiomyopathy
Questionnaire-Total Symptom Score (KCCQ-TSS) from baseline to month 8.
Results:
Overall, 5,795 patients had data available on KCCQ score. Patients with lower
baseline KCCQ-TSS were more likely to be White, women, and enrolled in Europe
or Americas with a higher proportion of comorbidities. Patients with lower
baseline KCCQ-TSS had higher rates of CV death or worsening HF. Dapagliflozin
was more effective in reducing CV death or worsening HF compared with placebo
in patients with higher baseline symptom burden. This effect was noted for
worsening HF but not for CV death individually. Improvements in health status
with dapagliflozin compared with placebo were noted as early as 1 month and
amplified over time. Number needed to treat to prevent a 5-point clinically
relevant deterioration in health status with dapagliflozin was 20 at 8 months.
Treatment effects were consistent across all EF subgroups.
Conclusions:
In a prespecified analysis of a placebo-controlled randomized trial, dapagliflozin
was more likely to reduce the composite of CV death and worsening HF in
patients with EF >40% with greater symptom burden at baseline, irrespective of
EF.
Perspective:
Patients with HF with mildly reduced and preserved EF form the large majority of
HF patients in the community. These patients often have a high burden of HF
symptoms with recurrent HF hospitalizations. SGLT2 inhibitors have been proven
to reduce risk for recurrent HF hospitalizations in this group, but prior data
suggest attenuation in effect in those with EF >60%. In this study, the effects of
dapagliflozin in improving health status and reducing risk for HF hospitalizations
were more in patients with higher baseline impairment. These effects were noted
as early as 1 month after treatment started and amplified over time, and were
consistent across all EF subgroups among individuals with EF >40%.
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