Sacubitril / Valsartan (Entresto) Entresto | European Medicines Agency (EMA)Skip to main contentSearchMain navigation * Medicines * Find medicine * Therapeutic areas: latest updates * Download medicine data * What we publish on medicines and when * Medicines under evaluation * National registers * Human regulatory * Overview * Research and development * Marketing authorisation * Post and left ventricular systolic dysfunction (a problem affecting the left side of the heart). Heart failure is the inability of the heart to pump enough blood around the body. Entresto contains the active substances sacubitril and valsartan. Expand sectionCollapse sectionHow is Entresto used?Entresto can only be obtained with a prescription. The medicine is available as tablets and granules to be taken
Sacubitril/valsartan (heart failure, children and adolescents) ' Addendum to Commission A23-56 1 Translation of addendum Sacubitril/Valsartan (Herzinsuffizienz, Kinder und Jugendliche) – Addendum zum Projekt A23-56 (Dossierbewertung). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Sacubitril/valsartan (heart failure, children and adolescents) Addendum to Project A23-56 (dossier assessment)1 ADDENDUM Project: A23-103 Version: 1.0 Status: 9 November 2023 Addendum A23-103 Version 1.0 Sacubitril/valsartan – Addendum to Project A23-56 9 November 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality
Sacubitril/valsartan (heart failure, children and adolescents) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 6 of the dossier assessment Sacubitril/Valsartan (Herzinsuffizienz, Kinder und Jugendliche) – Nutzenbewertung gemäß § 35a SGB V. Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Sacubitril/valsartan (heart failure, children and adolescents) Benefit assessment according to §35a SGB V1 EXTRACT Project: A23-56 Version: 1.1 Status: 31 October 2023 Extract of dossier assessment A23-56 Version 1.1 Sacubitril/valsartan ( heart failure, children and adolescents) 31 October 2023 Institute for Quality and Efficiency
Sacubitril/valsartan versus valsartan initiation in patients naïve to renin-angiotensin system inhibitors: Insights from PARAGLIDE-HF. Whether prior treatment with angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs) modifies efficacy and safety of sacubitril/valsartan (Sac/Val) in patients with heart failure (HF) and ejection fraction (EF) >40% is unclear , thus Sac/Val according to ACEi/ARB status at baseline was assessed. This was a pre-specified analysis of Prospective comparison of ARNI with ARB Given following stabiLization In DEcompensated HFpEF (PARAGLIDE-HF), a double-blind, randomized controlled trial of Sac/Val versus valsartan, categorizing patients according to baseline ACEi/ARB status. The primary endpoint was time-averaged proportional
In-Hospital or Out-of-Hospital Initiation of Sacubitril/Valsartan Versus Valsartan in Patients With Mildly Reduced or Preserved Ejection Fraction After A Worsening Heart Failure Event: The PARAGLIDE-HF Trial. Efficacy and tolerability of sacubitril/valsartan (Sac/Val) is not well characterized in heart failure (HF) with ejection fraction >40% initiated in-hospital. Thus, this prespecified PARAGLIDE-HF (Prospective Comparison of ARNI With ARB Given Following Stabilization In Decompensated HFpEF) analysis assessed the effects of Sac/Val versus valsartan (Val) by location of initiation in HF with ejection fraction >40% and recent worsening HF. This analysis of the double-blind, randomized controlled trial assessed patients by in-hospital and out-of-hospital (≤30 days of worsening HF
Patient Focus: Should You Take Sacubitril/Valsartan if You Have Heart Failure With an Ejection Fraction >40% and Low Blood Pressure? An Explanation of the Association of Sacubitril/Valsartan vs Valsartan With Blood Pressure Changes and Symptomatic Hypote
Dosing patterns and dose effects of sacubitril/valsartan: A claims-based retrospective cohort study. The goals of this retrospective cohort analysis were to determine real-world dose and titration patterns of sacubitril/valsartan (SAC/VAL), a heart failure medication, and examine whether dose patterns are associated with healthcare utilization and costs. Adult health plan members (18-100 years
Combination Use of Ivabradine with Sacubitril/Valsartan: A Review of Clinical Effectiveness and Guidelines Combination Use of Ivabradine with Sacubitril/Valsartan: A Review of Clinical Effectiveness and Guidelines | CADTH Skip to main content * About * Collaboration/Outreach * Patient/Community * Careers * Contact * My CADTH * FR * Reports * Reports * Reimbursement Review with Sacubitril/Valsartan: A Review of Clinical Effectiveness and Guidelines Copied to clipboard Combination Use of Ivabradine with Sacubitril/Valsartan: A Review of Clinical Effectiveness and Guidelines ( Last Updated : February 24, 2020) Project Line: Health Technology Review Project Sub Line: Summary with Critical Appraisal Project Number: RC1247-000 DetailsQuestion 1. 2. What is the clinical effectiveness
Sacubitril/Valsartan in Patients Hospitalized With Decompensated Heart Failure The efficacy and safety of sacubitril/valsartan in patients hospitalized with heart failure (HF) across the spectrum of left ventricular ejection fraction (EF) has not been described. Data from randomized trials of sacubitril/valsartan in HF patients with EF ≤40% (PIONEER-HF [Comparison of Sacubitril/Valsartan Versus trials of sacubitril/valsartan vs control therapy (enalapril or valsartan, respectively). All participants in the PIONEER-HF trial and 69.5% in the PARAGLIDE-HF trial were enrolled during hospitalization for HF after stabilization. The remainder in the PARAGLIDE-HF trial were enrolled ≤30 days after a WHF event. The primary endpoint of both trials was time-averaged proportional change in N-terminal pro
ENTRESTO - Sacubitril/valsartan (as sacubitril valsartan sodium hydrate complex) Search Page - Drug and Health Product Register * Skip to main content * Skip to "About this site"Language selection * FrançaisGovernment of CanadaSearch and menus * Search and menusSearchSearch websiteSearchTopics menu * Jobs * Immigration * Travel * Business * Benefits * Health * Taxes * More servicesYou are here
Rationale, Design and Baseline Characteristics of the PARAGLIDE-HF Trial: Sacubitril/Valsartan vs Valsartan in HFmrEF and HFpEF With a Worsening Heart Failure Event. The PARAGON-HF trial studied the effect of sacubitril/valsartan (Sac/Val) compared with valsartan (Val) on clinical outcomes in patients with chronic heart failure with preserved ejection fraction (HFpEF) or mildly reduced EF
Effect of fixed-dose combination Amlodipine/Valsartan in comparison to two Drug combination Nebivolol/Valsartan on 24-Hour Ambulatory Blood Pressure. Nebivolol has a dual mechanism of action, exerting a moderate b- blockade effect and reducing peripheral arterial resistance.,as a result, the antihypertensive effect of nebivolol may be higher than that of a potent vasodilator CCB such as amlodipine. The study evaluated the effect of two nebivolol/valsartan on 24-Hour ambulatory blood pressure versus amlodipine/valsartan in grade II or III hypertension patients or having uncontrolled BP despite treatment. Ambulatory blood pressure monitoring is a powerful method to monitor the changes in blood pressure over the 24-hour. A total of 74 from 90 patients continued the study. Fourty patients
Sacubitril/valsartan versus valsartan in regressing myocardial fibrosis in hypertension: a prospective, randomized, open-label, blinded endpoint clinical trial protocol. Diffuse interstitial myocardial fibrosis is a key common pathological manifestation in hypertensive heart disease (HHD) progressing to heart failure (HF). Angiotensin receptor-neprilysin inhibitors (ARNi), now a front-line ) is a prospective, randomized, open-label, blinded endpoint (PROBE) clinical trial. Adults with hypertension and left ventricular hypertrophy (LVH) according to Asian sex- and age-specific thresholds on cardiovascular magnetic resonance (CMR) imaging are randomized to treatment with either sacubitril/valsartan (an ARNi) or valsartan (an ARB) in 1:1 ratio for a duration of 52 weeks, at the end of which a repeat
Effects of switching from sacubitril/valsartan to valsartan alone on plasma levels of natriuretic peptides and myocardial remodeling in heart failure with reduced ejection fraction. We examined the effect of switching from angiotensin receptor-neprilysin inhibitor (ARNI) to angiotensin-receptor blocker (ARB) on plasma levels of natriuretic peptides and myocardial remodeling . This is a prospective study that included 11 patients with heart failure (HF) treated with ARNI. The patients were divided into two groups: 5 patients who continued treatment with sacubitril/valsartan 194/206 mg/day (ARNI-continue group) and 6 patients who were switched to valsartan 160 mg/day (ARB-switch group). The primary endpoint was percent change (%Change) in plasma A-, B-, and N-terminal pro-B-type natriuretic
Effect of Sacubitril/Valsartan vs Valsartan on Left Atrial Volume in Patients With Pre-Heart Failure With Preserved Ejection Fraction: The PARABLE Randomized Clinical Trial. Pre-heart failure with preserved ejection fraction (pre-HFpEF) is common and has no specific therapy aside from cardiovascular risk factor management. To investigate the hypothesis that sacubitril/valsartan vs valsartan peptide (BNP) greater than 20 pg/mL or N-terminal pro-b type natriuretic peptide greater than 100 pg/mL, left atrial volume index greater than 28 mL/m2, and preserved ejection fraction greater than 50% were included. Patients were randomized to angiotensin receptor neprilysin inhibitor sacubitril/valsartan titrated to 200 mg twice daily or matching angiotensin receptor blocker valsartan titrated to 160
Effect of sacubitril/valsartan or valsartan on ventricular remodeling and myocardial fibrosis in perimenopausal women with hypertension. To evaluate the impact of sacubitril/valsartan on blood pressure (BP), ventricular structure, and myocardial fibrosis compared with valsartan in perimenopausal hypertensive women. This prospective, randomized, actively controlled, open-label study included 292 women with perimenopausal hypertension. They were randomly divided into two groups: sacubitril/valsartan 200 mg once daily and valsartan 160 mg once daily for 24 weeks. The relevant indicators of ambulatory BP, echocardiography, and myocardial fibrosis regulation were assessed at baseline and at 24 weeks. The 24-h mean SBP after 24 weeks of treatment was 120.08 ± 10.47 mmHg in the sacubitril/valsartan
Sacubitril/Valsartan Cannot Improve Cardiac Function Compared with Valsartan in Patients Suffering Nonvalvular Atrial Fibrillation without Systolic Heart Failure. This study investigates the effect of sacubitril/valsartan (Sac/Val) in patients diagnosed with nonvalvular atrial fibrillation (AF) without systolic heart failure (SHF).Nonvalvular AF patients without SHF admitted to the People's Hospital of Bortala Mongol Autonomous Prefecture from December 2020 to December 2021 were enrolled and randomly divided into Sac/Val treatment group (group T) and valsartan treatment group (group C, control). For subgroup analysis, patients were divided into subgroups with and without diastolic heart failure (DHF). After 1-month adaptive phase and subsequent 3-month treatment period, patients were
Efficacy and Safety of Sacubitril/Valsartan Versus Amlodipine in Japanese Patients With Essential Hypertension: A Randomized, Multicenter, Open-Label, Noninferiority Study (PARASOL Study). Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, has demonstrated a superior blood pressure-lowering effect compared with renin-angiotensin system inhibitors in several clinical trials . However, there has been no available evidence on the comparison between sacubitril/valsartan and calcium channel blockers (CCBs), a well-established class of antihypertensive drugs. In this open-label, multicenter study, we aimed to demonstrate the efficacy and safety of sacubitril/valsartan versus amlodipine, one of the most widely used CCBs, after 8 weeks of treatment. A total of 359 Japanese patients
Sacubitril/Valsartan partially alleviates myocardial infarction injury by activating the FGF21 signaling pathway via PPARs. The recent discovery of clinically significant data, alongside novel physiological and pathological occurrences surrounding sacubitril/valsartan (Sac/Val) beyond its approved indications, necessitates an urgent reevaluation of its underlying mechanism of action
Valsartan and Cardiac Remodeling in Early-Stage Hypertrophic Cardiomyopathy: The VANISH Randomized Clinical Trial Cardiac Magnetic Resonance Substudy. Valsartan has been shown to attenuate phenotypic progression among individuals with early-stage sarcomeric hypertrophic cardiomyopathy (HCM). Myocardial tissue characterization by cardiac magnetic resonance (CMR) imaging may enhance mechanistic insights, but whether valsartan influences these parameters remains uncertain. To evaluate the treatment effects of valsartan on myocardial structure, function, and tissue parameters in early-stage sarcomeric HCM. This prespecified CMR substudy of the VANISH (Valsartan for Attenuating Disease Evolution in Early Sarcomeric Hypertrophic Cardiomyopathy) randomized clinical trial evaluated treatment effects