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Published on: April 8, 2013
Sacubitril/Valsartan in Patients Hospitalized With Decompensated Heart Failure
David A Morrow1, Eric J Velazquez2, Akshay S Desai3
1TIMI Study Group, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Sacubitril/valsartan significantly reduced NT-proBNP and cardiovascular events in patients hospitalized for worsening heart failure (WHF). The benefits were observed across a wide spectrum of left ventricular ejection fraction (EF) up to 60%.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Efficacy and safety of sacubitril/valsartan in hospitalized heart failure (HF) patients across the left ventricular ejection fraction (EF) spectrum were previously undescribed.
- Heart failure management requires understanding treatment effects across diverse EF ranges.
Purpose of the Study:
- To pool data from PIONEER-HF and PARAGLIDE-HF randomized trials to evaluate sacubitril/valsartan's treatment effect across the EF spectrum in patients hospitalized for worsening heart failure (WHF).
- To assess the impact of sacubitril/valsartan on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and clinical outcomes.
Main Methods:
- Pooled analysis of two double-blind, randomized trials (PIONEER-HF and PARAGLIDE-HF) comparing sacubitril/valsartan with control therapy (enalapril or valsartan).
- Patients were enrolled during hospitalization for HF or within 30 days of a WHF event.
- Primary endpoint was time-averaged proportional change in NT-proBNP; clinical endpoints were analyzed through follow-up.
Main Results:
- The pooled analysis included 1,347 patients, with a median EF of 30%.
- Sacubitril/valsartan demonstrated a 24% greater reduction in NT-proBNP compared to control therapy (P < 0.0001).
- Cardiovascular death or HF hospitalization was reduced by 30% (HR: 0.70; P = 0.0077), consistent across EF ≤60%. Symptomatic hypotension risk increased (RR: 1.35).
Conclusions:
- In patients stabilized after WHF, sacubitril/valsartan significantly reduced NT-proBNP and improved clinical outcomes compared to control therapy.
- These benefits were particularly evident across the spectrum of EF ≤60%.
- Sacubitril/valsartan is an effective treatment option for hospitalized HF patients across a broad EF range.
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