Sacubitril/Valsartan-Related Hypotension in Patients With Heart Failure and Preserved or Mildly Reduced Ejection Fraction

医学 沙库比林、缬沙坦 缬沙坦 射血分数 心脏病学 沙库比林 心力衰竭 内科学 血压
作者
Alberto Foà,Muthiah Vaduganathan,Brian Claggett,Maria Pabón,Henri Lu,Marc A. Pfeffer,Milton Packer,Orly Vardeny,Jean L. Rouleau,Martin Lefkowitz,Robert J. Mentz,Pardeep S. Jhund,Akshay S. Desai,John J.V. McMurray,Scott D. Solomon
出处
期刊:Journal of the American College of Cardiology [Elsevier BV]
卷期号:83 (18): 1731-1739 被引量:12
标识
DOI:10.1016/j.jacc.2024.02.035
摘要

Hypotension is a potential adverse effect of sacubitril/valsartan, but there are limited data regarding the predictors and implications of treatment-related hypotension in HFmrEF and HFpEF. We investigated predictors of treatment-associated hypotension, clinical outcomes after hypotension, and the relationship between LVEF and incidence of hypotension in the PARAGON-HF trial. PARAGON-HF randomized patients with chronic HF (≥45%) to sacubitril/valsartan or valsartan. Following randomization, hypotension was defined as investigator-reported hypotension with a SBP <100 mmHg. Predictors of hypotension were assessed using multivariable Cox models. Associations between hypotension and clinical outcomes were evaluated in time-updated Cox models. The relationship between treatment, LVEF, and incident rates of hypotension and clinical outcomes was estimated using Poisson regression models. Of 4,796 patients in PARAGON-HF, 637 (13%) experienced hypotension, more frequently in the sacubitril/valsartan arm (p<0.001). Following documented hypotension, patients had higher risk of CV death and total HF hospitalizations (adjusted RR 1.63; CI 1.27-2.09; p<0.001) and all-cause death (adjusted HR 1.62; CI 1.28-2.05; p<0.001). LVEF modified the association between sacubitril/valsartan and risk of hypotension (Pinteraction=0.019) such that patients with LVEF≥60% experienced substantially higher treatment-related risks of hypotension. In PARAGON-HF, a higher LVEF was associated with an increased risk of hypotension in patients treated with sacubitril/valsartan compared with valsartan. Since these subjects are also less likely to derive clinical benefit from sacubitril/valsartan, our data reinforce that the benefit/risk ratio favors the use of sacubitril/valsartan in patients with LVEF below normal, but not at higher LVEF.
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