Sacubitril/Valsartan-Related Hypotension in Patients with Heart Failure and Preserved or Mildly Reduced Ejection Fraction.
Details
Serval ID
serval:BIB_D6FF14CFB149
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Sacubitril/Valsartan-Related Hypotension in Patients with Heart Failure and Preserved or Mildly Reduced Ejection Fraction.
Journal
Journal of the American College of Cardiology
ISSN
1558-3597 (Electronic)
ISSN-L
0735-1097
Publication state
In Press
Peer-reviewed
Oui
Language
english
Notes
Publication types: Journal Article
Publication Status: aheadofprint
Publication Status: aheadofprint
Abstract
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 (P <sub>interaction</sub> =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.
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 (P <sub>interaction</sub> =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.
Keywords
blood pressure, heart failure, hypotension, sacubitril/valsartan
Pubmed
Create date
02/04/2024 9:41
Last modification date
03/04/2024 7:08