- June 30, 2021
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FDA Approves Verquvo (vericiguat) for Heart Failure with Reduced Ejection Fraction. The FDA approve… Background. April 2021. Shea CM(1), Price GM(2), Liu G(1), Sarno R(1), Buys ES(1), Currie MG(3), Masferrer JL(4). Cyclerion Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of soluble guanylate cyclase (sGC) pharmacology to discover, develop and commercialize breakthrough treatments for serious and orphan diseases. Session Late Breaking Trials II: Focus on chronic heart failure . 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%. Home Circulation Vol. It … The nitric oxide (NO)-soluble guanylate cyclase … The number of annual hospitalizations for heart failure (HF) and the mortality rates among patients hospitalized for HF remains unacceptably high. The search continues for safe and effective agents that improve outcomes when added to standard therapy. Heart failure (HF), which is characterized by the reduced ability of the heart to pump and/or fill with blood, is widely considered a global pandemic. To compensate for the related lack of nitric oxide (NO), a class of soluble guanylate cyclase (sGC) stimulators and act... Hemodynamic Effects of a Soluble Guanylate Cyclase Stimulator, Riociguat, and an Activator, Cinaciguat, During NO-Modulation in Healthy Pigs - Torvind Næsheim, Ole-Jakob How, Truls Myrmel, 2021 Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES) ... Rafael Kuperstein et al. 1 INTRODUCTION. Discovery of the soluble guanylate cyclase stimulator vericiguat (BAY 1021189) for the treatment of chronic heart failure. JAMA 2015;314:2251–62. Soluble guanylate cyclase (sGC) is a key enzyme in the nitric oxide (NO) signalling pathway. The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study (SOCRATES) programme consists of two randomized, parallel-group, placebo-controlled, double-blind, multicentre studies, SOCRATES-REDUCED (in patients with LVEF <45%) and SOCRATES-PRESERVED (in those with LVEF ≥45%), that will explore the pharmacodynamic effects, safety and tolerability, and … In: European Journal of Heart Failure. Merck & Co Inc. said Wednesday that the U.S. Food and Drug Administration has approved Verquvo, a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than … A stimulator of soluble guanylate cyclase indicated for the management of persistent or recurrent chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. This review summarizes the role of soluble guanylate cyclase (sGC)-cyclic guanosine 3', 5'-monophosphate pathways in heart failure and several new drugs that modify guanylate cyclase. 782-791. It … The sGC activators and stimulators as modulators of sGC are promising drugs in the therapy for decompensated heart failure and pulmonary hypertension. Objective: To determine the optimal dose and tolerability of vericiguat, a soluble guanylate cyclase stimulator, in patients with worsening chronic HF and reduced left ventricular ejection fraction (LVEF). Soluble guanylate cyclase (sGC) stimulation reduces inflammation and fibrosis in experimental models of lung, kidney and heart disease. JACC Heart Fail. Concomitant use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see CONTRAINDICATIONS). Design, setting, participants, & measurements In a phase 2 trial, 156 adults … Acute decompensated heart failure (ADHF) represents new or worsening symptoms of heart failure that necessitate hospitalization.1,2 As a leading cause of hospitalization in patients older than 65 years, ADHF is one of the most costly cardiovascular disorders.3,4 Acute decompensated heart failure is associated with severe cardiac diseases, and comorbidities including diabetes and renal disease.5 Activation of soluble guanylate cyclase (sGC) is attracting increasing interest as a therapeutic strategy for cardiovas… 2018;6:96-104. Effect of vericiguat, a soluble guanylate cyclase stimulator, on natriuretic peptide levels in patients with worsening chronic heart failure and reduced ejection fraction: the SOCRATES-REDUCED randomized trial. Heart failure (HF), which is characterized by the reduced ability of the heart to pump and/or fill with blood, is widely considered a global pandemic. 3 trials for chronic heart failure, are now reported. to guideline-based medical therapy in reducing incidence of heart failure hospitalization and mortality with sGC stimulator use. Heart failure is associated with an impaired NO–soluble guanylyl cyclase (sGC)–cGMP pathway and its augmentation is thought to be beneficial for its therapy. Think of Verquvo as a "Niche" Med for Heart Failure. Riociguat is a novel pulmonary vasodilator that acts via stimulation of soluble guanylate cyclase (sGC). Cyclic guanosine monophosphate (cGMP) is another key intracellular second messenger that counteracts the detrimental effects of cAM… IMPORTANCE Worsening chronic heart failure (HF) is a major public health problem. Soluble Guanylate Cyclase Modulators in Heart Failure 129 [7] Mitrovic V, Swidnicki B, Ghofrani A, et al. JAMA. Core Tip:Recently soluble guanylate cyclase (sGC) stimulators (vericiguat and riociguat) have emerged as a novel treatment for heart failure with … Gheorghiade M, Greene SJ, Butler J, et al. Despite significant advances in therapies and ... a soluble guanylate cyclase stimulator, in 5050 : Prior Authorization Criteria : OBJECTIVE To determine the optimal dose and tolerability of vericiguat, a soluble guanylate cyclase stimulator, in patients with worsening chronic HF and reduced left ventricular ejection fraction (LVEF). Pharmacological characterization of IW-1973, a novel soluble guanylate cyclase stimulator with extensive tissue distribution, antihypertensive, anti-inflammatory, and antifibrotic effects in preclinical models of disease. Discovery of the soluble guanylate cyclase stimulator vericiguat (BAY 1021189) for the treatment of chronic heart failure. Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES) ... Rafael Kuperstein et al. Rationale and design for a multicenter, randomized, double-blind, placebo-controlled, phase 2 study evaluating the safety and efficacy of the soluble guanylate cyclase stimulator praliciguat over 12 weeks in patients with heart failure with preserved ejection fraction (CAPACITY HFpEF). 2017 ; Vol. Vericiguat is currently being studied in a Phase III clinical program for the treatment of heart failure with reduced ejection fraction (HFrEF).
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