Circulation · 2025
Dapagliflozin in Patients Hospitalized for Heart Failure: Primary Results of the DAPA ACT HF-TIMI 68 Randomized Clinical Trial and Meta-Analysis of Sodium-Glucose Cotransporter-2 Inhibitors in Patients Hospitalized for Heart Failure.
СтатьяМетаанализРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Berg David D, Patel Siddharth M, Haller Paul M, Cange Abby L, Palazzolo Michael G, Bellavia Andrea, Kuder Julia F, Desai Akshay S, Inzucchi Silvio E, McMurray John J V, O'Meara Eileen, Verma Subodh, Bělohlávek Jan, Drożdż Jarosław, Merkely Béla, Ogunniyi Modele O, Drasnar Tomáš, Izzo Joseph L, Sarman Balazs, McGinty John E, Ramanathan Krishnan, Mulkay Angel J, Przybylski Andrzej, Ruff Christian T, O'Donoghue Michelle L, Murphy Sabina A, Sabatine Marc S, Wiviott Stephen D, DAPA ACT HF-TIMI 68 Trial Committees and Investigators
Аннотация
BACKGROUND: SGLT2 (sodium-glucose cotransporter-2) inhibitors reduce the risk of cardiovascular death or worsening heart failure (HF) in outpatients with HF. Data on initiation in patients hospitalized for HF are limited.
METHODS: We conducted a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of in-hospital initiation of dapagliflozin (10 mg daily) in patients hospitalized for HF. The primary efficacy outcome was a composite of time to cardiovascular death or worsening HF through 2 months. Key safety outcomes included symptomatic hypotension and worsening kidney function. A prespecified meta-analysis of randomized trials evaluating initiation of SGLT2 inhibitors in patients hospitalized for HF was performed.
RESULTS: Of 2401 patients (median age, 69 [Q1-Q3, 58-77] years, 815 [33.9%] women, 448 [18.7%] Black race, 1717 [71.5%] left ventricular ejection fraction ≤40%, 1074 [44.7%] newly diagnosed HF) randomized between September 2020 and March 2025, 1218 were assigned to dapagliflozin and 1183 to placebo. The primary outcome occurred in 133 patients (10.9%) in the dapagliflozin group and 150 (12.7%) in the placebo group (hazard ratio [HR], 0.86 [95% CI, 0.68-1.08]; P=0.20). A worsening HF event occurred in 115 (9.4%) and 122 (10.3%) patients in the dapagliflozin and placebo groups, respectively (HR, 0.91 [95% CI, 0.71-1.18]). Cardiovascular death occurred in 30 (2.5%) and 37 (3.1%) patients (HR, 0.78 [95% CI, 0.48-1.27]), and death from any cause occurred in 36 (3.0%) and 53 (4.5%) patients in the dapagliflozin and placebo groups, respectively (HR, 0.66 [95% CI, 0.43-1.00]). The rates of symptomatic hypotension were 3.6% and 2.2%, and the rates of worsening kidney function were 5.9% and 4.7% with dapagliflozin and placebo, respectively. In a meta-analysis of patients hospitalized for HF, SGLT2 inhibitors reduced the early risk of cardiovascular death or worsening HF (HR, 0.71 [95% CI, 0.54-0.93] P=0.012) and of all-cause death (HR, 0.57 [95% CI, 0.41-0.80]; P=0.001).
CONCLUSIONS: In this trial, in-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF through 2 months in hospitalized HF patients. However, the totality of randomized clinical trial data suggests that in-hospital initiation of SGLT2 inhibitors may reduce the early risk of cardiovascular death or worsening HF and of all-cause mortality.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04363697.
METHODS: We conducted a randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of in-hospital initiation of dapagliflozin (10 mg daily) in patients hospitalized for HF. The primary efficacy outcome was a composite of time to cardiovascular death or worsening HF through 2 months. Key safety outcomes included symptomatic hypotension and worsening kidney function. A prespecified meta-analysis of randomized trials evaluating initiation of SGLT2 inhibitors in patients hospitalized for HF was performed.
RESULTS: Of 2401 patients (median age, 69 [Q1-Q3, 58-77] years, 815 [33.9%] women, 448 [18.7%] Black race, 1717 [71.5%] left ventricular ejection fraction ≤40%, 1074 [44.7%] newly diagnosed HF) randomized between September 2020 and March 2025, 1218 were assigned to dapagliflozin and 1183 to placebo. The primary outcome occurred in 133 patients (10.9%) in the dapagliflozin group and 150 (12.7%) in the placebo group (hazard ratio [HR], 0.86 [95% CI, 0.68-1.08]; P=0.20). A worsening HF event occurred in 115 (9.4%) and 122 (10.3%) patients in the dapagliflozin and placebo groups, respectively (HR, 0.91 [95% CI, 0.71-1.18]). Cardiovascular death occurred in 30 (2.5%) and 37 (3.1%) patients (HR, 0.78 [95% CI, 0.48-1.27]), and death from any cause occurred in 36 (3.0%) and 53 (4.5%) patients in the dapagliflozin and placebo groups, respectively (HR, 0.66 [95% CI, 0.43-1.00]). The rates of symptomatic hypotension were 3.6% and 2.2%, and the rates of worsening kidney function were 5.9% and 4.7% with dapagliflozin and placebo, respectively. In a meta-analysis of patients hospitalized for HF, SGLT2 inhibitors reduced the early risk of cardiovascular death or worsening HF (HR, 0.71 [95% CI, 0.54-0.93] P=0.012) and of all-cause death (HR, 0.57 [95% CI, 0.41-0.80]; P=0.001).
CONCLUSIONS: In this trial, in-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening HF through 2 months in hospitalized HF patients. However, the totality of randomized clinical trial data suggests that in-hospital initiation of SGLT2 inhibitors may reduce the early risk of cardiovascular death or worsening HF and of all-cause mortality.
REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04363697.