Key result
Dapagliflozin cuts worsening HF or CV death by ~22% regardless of sleep apnea status.
Why the study?
Little is known about the association of sleep apnea with clinical outcomes across heart failure phenotypes, or how it modifies the effect of heart failure therapy.
Does dapagliflozin reduce the composite of worsening HF or cardiovascular death in heart failure patients with and without sleep apnea?
Meta-Analysis (n=11,000)
Yes
Does dapagliflozin reduce the composite of worsening HF or cardiovascular death in heart failure patients with and without sleep apnea?
Effect estimate: HR 0.78 (95% CI 0.59-1.03)
p-value: Pinteraction=0.93
Dapagliflozin consistently reduces the risk of worsening heart failure or cardiovascular death in patients across the spectrum of ejection fractions, regardless of comorbid sleep apnea.
Dapagliflozin benefit holds irrespective of sleep apnea; extends prior trial evidence to this comorbidity.
BackgroundSleep apnea is more common in patients with heart failure (HF) than in the general population, but little is known about its association with clinical outcomes in different HF phenotypes or how it might modify the effect of HF therapy.ObjectivesTo examine the prevalence of sleep apnea, its association with outcomes, and the effects of dapagliflozin in HF patients with and without sleep apnea in a pooled analysis of two trials comparing dapagliflozin to placebo in HFrEF (DAPA-HF) and HFmrEF/HFpEF (DELIVER).MethodsA history of sleep apnea was investigator-reported. The primary outcome was a composite of worsening HF or cardiovascular death.ResultsThe prevalence of sleep apnea was 5.7% and 7.8% in patients with HFrEF and HFmrEF/HFpEF, respectively. The primary outcome occurred at a rate of 16.0 in participants with sleep apnea compared to 10.6 per 100 person-years in those without (adjusted HR 1.29 [95%CI, 1.10-1.52]). Compared with placebo, dapagliflozin reduced the risk of the primary endpoint to the same extent in patients with (HR 0.78 [95% CI, 0.59-1.03]) and without sleep apnea (HR 0.79 [0.72-0.87]) [Pinteraction=0.93]. The beneficial effects of dapagliflozin on other clinical outcomes and symptom burden, physical function, and quality of life were consistent in participants with and without sleep apnea.ConclusionsIn DAPA-HF and DELIVER, the true prevalence of sleep apnea was likely underestimated.An investigator-reported history of sleep apnea was associated with higher rates of worsening HF events. The benefits of dapagliflozin on clinical outcomes were consistent in patients with and without sleep apnea.Condensed abstractIn a pooled analysis of the DAPA-HF and DELIVER trials of more than 11,000 patients with heart failure (HF) across the range of ejection fractions, an investigator-reported history of sleep apnea was associated with higher rates of worsening HF events, but not mortality. The beneficial effects of dapagliflozin on clinical outcomes were consistent in patients with and without sleep apnea. These findings provide further evidence for dapagliflozin as a new treatment option for patients with heart failure across the range of ejection fractions.
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Butt et al. (2023) conducted a meta-analysis in Heart failure (n=11,000). Dapagliflozin vs. Placebo was evaluated on Composite of worsening HF or cardiovascular death (HR 0.78, 95% CI 0.59-1.03, p=Pinteraction=0.93). Dapagliflozin reduced the risk of worsening heart failure or cardiovascular death consistently in patients with (HR 0.78; 95% CI 0.59-1.03) and without sleep apnea (Pinteraction=0.93).
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