Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial

Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomati...

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Autores principales:	Carolyn S. P. Lam, Hillary Mulder, Yuri Lopatin, Jose B. Vazquez‐Tanus, David Siu, Justin Ezekowitz, Burkert Pieske, Christopher M. O’Connor, Lothar Roessig, Mahesh J. Patel, Kevin J. Anstrom, Adrian F. Hernandez, Paul W. Armstrong
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	blood pressure heart failure heart failure with reduced ejection fraction safety events vericiguat Diseases of the circulatory (Cardiovascular) system RC666-701
Acceso en línea:	https://doaj.org/article/746573cb9e5446779c083cce06f77a82
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spelling	oai:doaj.org-article:746573cb9e5446779c083cce06f77a822021-11-16T10:22:43ZBlood Pressure and Safety Events With Vericiguat in the VICTORIA Trial10.1161/JAHA.121.0210942047-9980https://doaj.org/article/746573cb9e5446779c083cce06f77a822021-11-01T00:00:00Zhttps://www.ahajournals.org/doi/10.1161/JAHA.121.021094https://doaj.org/toc/2047-9980Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomatic hypotension, such as older patients, those with lower baseline systolic blood pressure (SBP), or those concurrently taking angiotensin receptor neprilysin inhibitors. We described the SBP trajectories over time and compared the occurrence of symptomatic hypotension or syncope by treatment arm in potentially vulnerable subgroups in VICTORIA. We also evaluated the relation between the efficacy of vericiguat and baseline SBP. Methods and Results Among patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75 years old (n=1395), those with baseline SBP 100–110 mm Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730). SBP trajectory was plotted as mean change from baseline over time. The treatment effect on time to symptomatic hypotension or syncope was evaluated overall and by subgroup, and the primary efficacy composite outcome (heart failure hospitalization or cardiovascular death) across baseline SBP was examined using Cox proportional hazards models. SBP trajectories showed a small initial decline in SBP with vericiguat in those >75 years old (versus younger patients), as well as those receiving angiotensin receptor neprilysin inhibitors (versus none), with SBP returning to baseline thereafter. Patients with SBP <110 mm Hg at baseline showed a trend to increasing SBP over time, which was similar in both treatment arms. Safety event rates were generally low and similar between treatment arms within each subgroup. In Cox proportional hazards analysis, there were similar numbers of safety events with vericiguat versus placebo (adjusted hazard ratio [HR], 1.18; 95% CI, 0.99–1.39; P=0.059). No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks) (adjusted HR, 1.14; 95% CI, 0.93–1.38; P=0.20). The benefit of vericiguat compared with placebo on the primary composite efficacy outcome was similar across the spectrum of baseline SBP (P for interaction=0.32). Conclusions These data demonstrate the safety of vericiguat in a broad population of patients with worsening heart failure with reduced ejection fraction, even among those predisposed to hypotension. Vericiguat’s efficacy persisted regardless of baseline SBP. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02861534.Carolyn S. P. LamHillary MulderYuri LopatinJose B. Vazquez‐TanusDavid SiuJustin EzekowitzBurkert PieskeChristopher M. O’ConnorLothar RoessigMahesh J. PatelKevin J. AnstromAdrian F. HernandezPaul W. ArmstrongWileyarticleblood pressureheart failureheart failure with reduced ejection fractionsafety eventsvericiguatDiseases of the circulatory (Cardiovascular) systemRC666-701ENJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease, Vol 10, Iss 22 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	blood pressure heart failure heart failure with reduced ejection fraction safety events vericiguat Diseases of the circulatory (Cardiovascular) system RC666-701
spellingShingle	blood pressure heart failure heart failure with reduced ejection fraction safety events vericiguat Diseases of the circulatory (Cardiovascular) system RC666-701 Carolyn S. P. Lam Hillary Mulder Yuri Lopatin Jose B. Vazquez‐Tanus David Siu Justin Ezekowitz Burkert Pieske Christopher M. O’Connor Lothar Roessig Mahesh J. Patel Kevin J. Anstrom Adrian F. Hernandez Paul W. Armstrong Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
description	Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomatic hypotension, such as older patients, those with lower baseline systolic blood pressure (SBP), or those concurrently taking angiotensin receptor neprilysin inhibitors. We described the SBP trajectories over time and compared the occurrence of symptomatic hypotension or syncope by treatment arm in potentially vulnerable subgroups in VICTORIA. We also evaluated the relation between the efficacy of vericiguat and baseline SBP. Methods and Results Among patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75 years old (n=1395), those with baseline SBP 100–110 mm Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730). SBP trajectory was plotted as mean change from baseline over time. The treatment effect on time to symptomatic hypotension or syncope was evaluated overall and by subgroup, and the primary efficacy composite outcome (heart failure hospitalization or cardiovascular death) across baseline SBP was examined using Cox proportional hazards models. SBP trajectories showed a small initial decline in SBP with vericiguat in those >75 years old (versus younger patients), as well as those receiving angiotensin receptor neprilysin inhibitors (versus none), with SBP returning to baseline thereafter. Patients with SBP <110 mm Hg at baseline showed a trend to increasing SBP over time, which was similar in both treatment arms. Safety event rates were generally low and similar between treatment arms within each subgroup. In Cox proportional hazards analysis, there were similar numbers of safety events with vericiguat versus placebo (adjusted hazard ratio [HR], 1.18; 95% CI, 0.99–1.39; P=0.059). No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks) (adjusted HR, 1.14; 95% CI, 0.93–1.38; P=0.20). The benefit of vericiguat compared with placebo on the primary composite efficacy outcome was similar across the spectrum of baseline SBP (P for interaction=0.32). Conclusions These data demonstrate the safety of vericiguat in a broad population of patients with worsening heart failure with reduced ejection fraction, even among those predisposed to hypotension. Vericiguat’s efficacy persisted regardless of baseline SBP. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02861534.
format	article
author	Carolyn S. P. Lam Hillary Mulder Yuri Lopatin Jose B. Vazquez‐Tanus David Siu Justin Ezekowitz Burkert Pieske Christopher M. O’Connor Lothar Roessig Mahesh J. Patel Kevin J. Anstrom Adrian F. Hernandez Paul W. Armstrong
author_facet	Carolyn S. P. Lam Hillary Mulder Yuri Lopatin Jose B. Vazquez‐Tanus David Siu Justin Ezekowitz Burkert Pieske Christopher M. O’Connor Lothar Roessig Mahesh J. Patel Kevin J. Anstrom Adrian F. Hernandez Paul W. Armstrong
author_sort	Carolyn S. P. Lam
title	Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
title_short	Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
title_full	Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
title_fullStr	Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
title_full_unstemmed	Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial
title_sort	blood pressure and safety events with vericiguat in the victoria trial
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/746573cb9e5446779c083cce06f77a82
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Blood Pressure and Safety Events With Vericiguat in the VICTORIA Trial

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