Health Status With Dapagliflozin in HF With Mildly Reduced or Preserved EF

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?

Methods:

This is a prespecified analysis of the DELIVER (Dapagliflozin Evaluation to Improve 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%.

Clinical Topics: Geriatric Cardiology, Heart Failure and Cardiomyopathies, Prevention, Acute Heart Failure, Heart Failure and Cardiac Biomarkers

Keywords: Cardiomyopathies, Comorbidity, Geriatrics, Health Status, Heart Failure, Natriuretic Peptide, Brain, Risk, Secondary Prevention, Sodium-Glucose Transporter 2 Inhibitors, Stroke Volume


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