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Emerging concepts in heart failure management and treatment: focus on vericiguat.
Drugs Context
January 2023
Catholic University Argentina/Fleni Institute, Buenos Aires, Argentina.
The nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) pathway is dysregulated in patients with heart failure (HF) resulting in myocardial and vascular dysfunction that contributes to its progression. Vericiguat is a novel direct sGC stimulator that targets in at least two ways the NO-sGC-cGMP pathway with the subsequent restoration of cGMP activity. The VICTORIA trial assessed the effects of vericiguat ( placebo) in 5050 patients with chronic HF (NYHA class II-IV), left ventricular ejection fraction (LVEF) <45%, elevated natriuretic peptide levels and a recent HF decompensation (hospitalized or outpatient intravenous diuretics).
View Article and Find Full Text PDFVericiguat in Heart Failure: Characteristics, Scientific Evidence and Potential Clinical Applications.
Biomedicines
October 2022
Cardiovascular Diseases Unit, Cardio-Thoracic and Vascular Department, "Le Scotte" Hospital Siena, University of Siena, 53100 Siena, Italy.
Despite recent advances in heart failure (HF) management, the risk of death and hospitalizations remains high in the long term. HF is characterized by endothelial dysfunction, inflammation and increased oxidative stress, due to a reduction in the activity of the nitric oxide (NO)-soluble guanylate cyclase (sGC)-cyclic guanosine monophosphate (cGMP) signaling pathway. All these factors contribute to direct damage at the myocardial, vascular and renal level.
View Article and Find Full Text PDFPopulation Pharmacokinetics of Vericiguat in Patients With Heart Failure With Reduced Ejection Fraction: An Integrated Analysis.
Clin Pharmacol Ther
November 2022
Merck & Co., Inc., Rahway, New Jersey, USA.
Vericiguat, a novel stimulator of soluble guanylate cyclase (sGC), is indicated for the treatment of patients following a hospitalization for heart failure or need for outpatient intravenous diuretics, with symptomatic chronic heart failure and ejection fraction less than 45%. Pharmacokinetic (PK) data from the phase II trial SOCRATES-REDUCED (Soluble Guanylate Cyclase Stimulator in Heart Failure Study) and the phase III trial VICTORIA (Vericiguat Global Study in Patients With Heart Failure With Reduced Ejection Fraction) were used to characterize vericiguat PK. A total of 8,092 concentration records from 2,321 participants (362 from SOCRATES-REDUCED and 1,959 from VICTORIA) were utilized for the development of the population PK model.
View Article and Find Full Text PDFPopulation Pharmacokinetics and Pharmacodynamics of Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.
Clin Pharmacokinet
November 2021
Pharmacometrics, Bayer AG, Aprather Weg 18a, 42113, Wuppertal, Germany.
Background: Vericiguat, a stimulator of soluble guanylate cyclase, has been developed as a first-in-class therapy for worsening chronic heart failure in adults with left ventricular ejection fraction < 45%.
Objective: The objective of this article was to characterize the pharmacokinetics and pharmacokinetic variability of vericiguat combined with guideline-directed medical therapy (standard of care), and identify exposure-response relationships for safety (hemodynamics) and pharmacodynamic markers of efficacy (N-terminal pro-B-type natriuretic peptide concentration [NT-proBNP]) in patients with heart failure and left ventricular ejection fraction < 45% in the SOCRATES-REDUCED study (NCT01951625).
Methods: Vericiguat and NT-proBNP plasma concentrations in 454 and 432 patients in SOCRATES-REDUCED, respectively, were analyzed using nonlinear mixed-effects modeling.
Left atrial strain as sensitive marker of left ventricular diastolic dysfunction in heart failure.
ESC Heart Fail
August 2020
Department of Internal Medicine and Cardiology, Charité University Medicine (Campus Virchow Klinikum), Augustenburger Platz 1, Berlin, 13353, Germany.
Aims: The purpose of this retrospective analysis was to examine the association of left atrial (LA) strain (i.e. LA reservoir function) with left ventricular diastolic dysfunction (DD) in patients with heart failure with reduced and preserved left ventricular ejection fraction (LVEF).
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