European journal of heart failure · 2025
Sacubitril/valsartan versus valsartan initiation in patients naïve to renin-angiotensin system inhibitors: Insights from PARAGLIDE-HF.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Nouhravesh Nina, Gunn Alexander H, Cyr Derek, Hernandez Adrian F, Morrow David A, Velazquez Eric J, Ward Jonathan H, Sarwat Samiha, Sharma Kavita, Williamson Kristin M, Starling Randall C, Lepage Serge, Zieroth Shelley, Solomon Scott D, Mentz Robert J
Аннотация
AIMS: Whether prior treatment with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) modifies efficacy and safety of sacubitril/valsartan (Sac/Val) in patients with heart failure (HF) and ejection fraction (EF) >40% is unclear, thus Sac/Val according to ACEi/ARB status at baseline was assessed.
METHODS AND RESULTS: This was a pre-specified analysis of Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE-HF), a double-blind, randomized controlled trial of Sac/Val versus valsartan, categorizing patients according to baseline ACEi/ARB status. The primary endpoint was time-averaged proportional change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline through weeks 4 and 8. Secondary analyses included a win-ratio analysis of the hierarchical outcome of (i) cardiovascular death; (ii) HF hospitalizations; (iii) urgent HF visits; and (iv) time-averaged proportional change in NT-proBNP from baseline to weeks 4 and 8, in addition to safety outcomes. Among 466 patients, 107 (23%) were ACEi/ARB naïve at the time of randomization. NT-proBNP favoured Sac/Val irrespective of ACEi/ARB status (naïve: 0.76, 95% confidence interval [CI] 0.51-1.13; users: 0.88, 95% CI 0.74-1.05; pinteraction = 0.52). The win ratio of the hierarchical outcome was 1.13 (95% CI 0.86-1.49) for ACEi/ARB users and 1.38 (95% CI 0.81-2.37) for ACEi/ARB naïve (pinteraction = 0.51). Safety endpoints showed non-significant interactions by ACEi/ARB status, with odds ratio of 1.79 (95% CI 0.68-4.72) and 0.71 (95% CI 0.29-1.78) for symptomatic hypotension and worsening renal function, respectively for ACEi/ARB naïve.
CONCLUSION: In HF with EF >40% stabilized after worsening HF, safety and efficacy were similar irrespective of ACEi/ARB status at baseline, supporting early initiation irrespective of prior ACEi/ARB use.
METHODS AND RESULTS: This was a pre-specified analysis of Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE-HF), a double-blind, randomized controlled trial of Sac/Val versus valsartan, categorizing patients according to baseline ACEi/ARB status. The primary endpoint was time-averaged proportional change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) from baseline through weeks 4 and 8. Secondary analyses included a win-ratio analysis of the hierarchical outcome of (i) cardiovascular death; (ii) HF hospitalizations; (iii) urgent HF visits; and (iv) time-averaged proportional change in NT-proBNP from baseline to weeks 4 and 8, in addition to safety outcomes. Among 466 patients, 107 (23%) were ACEi/ARB naïve at the time of randomization. NT-proBNP favoured Sac/Val irrespective of ACEi/ARB status (naïve: 0.76, 95% confidence interval [CI] 0.51-1.13; users: 0.88, 95% CI 0.74-1.05; pinteraction = 0.52). The win ratio of the hierarchical outcome was 1.13 (95% CI 0.86-1.49) for ACEi/ARB users and 1.38 (95% CI 0.81-2.37) for ACEi/ARB naïve (pinteraction = 0.51). Safety endpoints showed non-significant interactions by ACEi/ARB status, with odds ratio of 1.79 (95% CI 0.68-4.72) and 0.71 (95% CI 0.29-1.78) for symptomatic hypotension and worsening renal function, respectively for ACEi/ARB naïve.
CONCLUSION: In HF with EF >40% stabilized after worsening HF, safety and efficacy were similar irrespective of ACEi/ARB status at baseline, supporting early initiation irrespective of prior ACEi/ARB use.
Предметные рубрики MeSH
HumansValsartanAminobutyratesBiphenyl CompoundsFemaleMaleHeart FailureDrug CombinationsDouble-Blind MethodAgedTetrazolesAngiotensin Receptor AntagonistsStroke VolumeNatriuretic Peptide, BrainRenin-Angiotensin SystemPeptide FragmentsMiddle AgedTreatment OutcomeProspective StudiesAngiotensin-Converting Enzyme Inhibitors