Dapagliflozin in Patients Hospitalized for Heart Failure: Primary Results of the DAPA ACT HF-TIMI 68 Randomized Clinical Trial and Meta-Analysis of SGLT2 Inhibitors in Patients Hospitalized for Heart Failure
In the DAPA ACT HF-TIMI 68 trial, starting dapagliflozin during a heart-failure hospitalization did not significantly reduce cardiovascular death or worsening heart failure at 2 months, but a meta-analysis of all such trials suggests in-hospital SGLT2-inhibitor initiation does reduce early cardiovascular death/worsening HF and all-cause death.
Background
SGLT2 inhibitors reduce cardiovascular death and worsening heart failure in outpatients with chronic HF, but evidence for starting them in patients hospitalized for acute HF was limited. This trial tested in-hospital initiation of dapagliflozin.
Study design
Randomized, double-blind, placebo-controlled trial (NCT04363697) in 2401 patients hospitalized for HF (enrolled regardless of ejection fraction, diabetes, or HF chronicity), assigned to dapagliflozin 10 mg daily or placebo. The primary efficacy outcome was time to cardiovascular death or worsening HF through 2 months; a prespecified meta-analysis pooled trials of in-hospital SGLT2-inhibitor initiation.
Key findings
The primary outcome occurred in 10.9% with dapagliflozin versus 12.7% with placebo (HR 0.86, 95% CI 0.68–1.08; P=0.20) — not statistically significant. All-cause death was 3.0% versus 4.5% (HR 0.66, 95% CI 0.43–1.00). Symptomatic hypotension (3.6% vs 2.2%) and worsening kidney function (5.9% vs 4.7%) were slightly more frequent with dapagliflozin. In the meta-analysis, SGLT2 inhibitors reduced early cardiovascular death/worsening HF (HR 0.71, 95% CI 0.54–0.93; P=0.012) and all-cause death (HR 0.57, 95% CI 0.41–0.80; P=0.001).
Clinical implications
Although this individual trial did not reach significance (likely underpowered for the low early event rate), the totality of randomized evidence supports initiating an SGLT2 inhibitor before discharge in patients hospitalized for heart failure, given its early benefit and acceptable safety.
Category
Research
Source
Circulation
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