Sacubitril/valsartan eligibility and outcomes in the ESC‐EORP‐HFA Heart Failure Long‐Term Registry: bridging between European Medicines Agency/Food and Drug Administration label, the PARADIGM‐HF trial, ESC guidelines, and real world (original) (raw)
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Cardiovascular Drugs and Therapy, 2019
Purpose PARADIGM-HF demonstrated the superiority of sacubitril/valsartan over enalapril in patients with heart failure and reduced ejection fraction (HF-REF). How widely applicable sacubitril/valsartan treatment is in unselected patients with HF-REF is not known. We examined eligibility of patients with HF-REF for treatment with sacubitril/valsartan, according to the criteria used in PARADIGM-HF, in the Swedish Heart Failure Registry (SwedeHF). Methods Patients were considered potentially eligible if they were not hospitalized, had symptoms (NYHA class II-IV) and a reduced LVEF (≤ 40%), and were prescribed an angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose equivalent to enalapril ≥ 10 mg daily. In these patients, we evaluated further eligibility according to the main additional PARADIGM-HF inclusion criteria. Results Of 12,866 outpatients in NYHA functional class II-IV with an LVEF ≤ 40%, 9577 were prescribed at least 10 mg of enalapril (or equivalent) daily. Complete additional data were available for 3099 of these patients (32.4%) and of them 75.5% were potentially eligible for treatment with sacubitril/valsartan. The most common reason for ineligibility was a low natriuretic peptide level (n = 462, 14.9%). Only a small proportion of patients were ineligible due to low eGFR or serum potassium level. Because only 78% of patients were taking ≥ 10 mg enalapril or equivalent daily, only 58.9% of all patients (75.5% of 78%) were eligible for sacubitril/valsartan. Conclusions Between 34 and 76% of symptomatic patients with HF-REF in a 'real world' population are eligible for treatment with sacubitril/valsartan, depending on background ACEI/ARB dose. The most common reason for ineligibility is a low natriuretic peptide level.
ESC Heart Failure
AimsARIADNE aimed to assess the association between effects of sacubitril/valsartan and no sacubitril/valsartan treatment and clinical characteristics, functional capacity, and clinical outcomes (cause‐specific mortality and hospitalizations) in outpatients with heart failure (HF) with reduced ejection fraction (HFrEF).MethodsARIADNE was a prospective European registry of 9069 patients with HFrEF treated by office‐based cardiologists or selected primary care physicians. Of the 8787 eligible for analysis, 4173 patients were on conventional HF treatment (non‐S/V group), whereas 4614 patients were either on sacubitril/valsartan treatment at enrolment or started sacubitril/valsartan within 1 month of enrolment (S/V group). We also generated a restricted analysis set (rS/V) including only those 2108 patients who started sacubitril/valsartan treatment within the month prior to or after enrolment.ResultsAt the baseline, average age of patients enrolled in the study was 68 years, and 23.9% ...
What proportion of patients with chronic heart failure are eligible for sacubitril-valsartan?
European journal of heart failure, 2017
The PARADIGM-HF trial showed that sacubitril-valsartan, an ARB-neprilysin inhibitor, is more effective than enalapril for some patients with heart failure (HF). It is uncertain what proportion of patients with HF would be eligible for sacubitril-valsartan in clinical practice. Between 2001 and 2014, 6131 patients consecutively referred to a community HF clinic with suspected HF were assessed. The criteria required to enter the randomized phase of PARADIGM-HF, including symptoms, NT-proBNP, and current treatment with or without target doses of ACE inhibitors or ARBs, were applied to identify the proportion of patients eligible for sacubitril-valsartan. Recognizing the diversity of clinical opinion and guideline recommendations concerning this issue, entry criteria were applied singly and in combination. Of 1396 patients with reduced left ventricular ejection fraction (≤40%, HFrEF) and contemporary measurement of NT-proBNP, 379 were on target doses of an ACE inhibitor or ARB at their ...
Eligibility for sacubitril-valsartan in patients with acute decompensated heart failure
ESC Heart Failure
Aims Large-scale clinical trials have demonstrated clinical benefits of sacubitril-valsartan in symptomatic heart failure with reduced ejection fraction patients (PARADIGM-HF), with potential benefits in patients hospitalized for acute decompensated heart failure (ADHF) (PIONEER-HF) and fewer benefits in patients with heart failure with preserved ejection fraction (PARA-GON-HF). The aim of this study was to evaluate eligibility for sacubitril-valsartan using criteria described in PIONNER-HF in non-selected patients hospitalized for ADHF. Methods and results Between November 2014 and May 2019, 799 patients were recruited in a prospective registry of acute heart failure at the University Hospitals of Geneva (ClinicalTrials.gov: NCT02444416). The cohort consists of consecutive patients admitted to the Department of Medicine with ADHF. Eligibility for sacubitril-valsartan was determined using criteria described in PIONEER-HF, including left ventricular ejection fraction, clinical parameters, and co-morbidities. Of 799 patients, 123 (15.39%) were eligible for sacubitril-valsartan treatment. Clinical outcomes including all-cause mortality and readmission were similar in eligible and non-eligible groups, hazard ratio 1.02 (95% confidence interval 0.81-1.29, P = 083). Conclusions Using current criteria from randomized controlled trials, only 15% of non-selected patients admitted for ADHF are theoretically eligible for sacubitril-valsartan. Eligibility for sacubitril-valsartan using published criteria is not associated with worse outcome, suggesting that further evaluation of benefits of sacubitril-valsartan in heart failure patients based on parameters other than left ventricular ejection fraction may be of interest.
Frontiers in Pharmacology
Heart failure (HF) represents a widespread health problem characterized by high morbidity and mortality. Sacubitril/Valsartan (sac/val) has improved clinical prognosis in patients affected by HF with reduced ejection fraction (HFrEF). The aim of this study was to evaluate the effectiveness and durability of sac/val treatment on the clinical, hemodynamic and echocardiographic parameters, in real-life consecutive HFrEF outpatients, evaluated up to 2-years of follow-up. We collected 300 repeated observations over time in 60 patients suffering of HFrEF and symptomatic despite optimal drug therapy. Patients with left ventricular ejection fraction (LVEF) <35 and II-III NYHA functional class were considered. All patients underwent to clinical-instrumental and laboratory determinations and Minnesota Living with HF Questionnaire (MLHFQ) every 6 months until 24 months to evaluate possible clinical benefits and adverse events. During a 2-year follow-up period and through a 6-monthly control...
Open Heart, 2020
BackgroundSacubitril/valsartan is an effective treatment for heart failure with reduced ejection fraction (HFrEF) based on clinical trial data. However, little is known about its use or impact in real-world practice. The aim of this study was to describe our routine clinical experience of switching otherwise optimally treated patients with HFrEF to sacubitril/valsartan with respect to patient outcomes such as quality of life (QoL) and echocardiographic variables.Methods and resultsFrom June 2017 to May 2019, 80 consecutive stable patients with HFrEF on established and maximally tolerated guideline-directed HF therapies were initiated on sacubitril/valsartan with bimonthly uptitration. Clinical assessment, biochemistry, echocardiography and QoL were compared pretreatment and post-treatment switching. We were able to successfully switch 89% of patients from renin–angiotensin axis inhibitors to sacubitril/valsartan (71 of 80 patients). After 3 months of switch therapy, we observed clin...
CJC Open, 2020
Background: To determine the effectiveness of sacubitril/valsartan 97/103 mg twice daily (b.i.d.) on tolerability, safety, and quality of life (QoL) in Canadian patients with heart failure with reduced ejection fraction in a real-life setting. Methods: In Prospective, Multicenter, Open Label, Post-Approval Study Aimed at Characterizing the Use of LCZ696 at 97 mg Sacubitril/103 mg Valsartan bid in Patients With HFrEF (PARASAIL), an open-label, prospective, phase IV, multicentre study, outpatients with heart failure with reduced ejection fraction and New York Heart Association functional class II-III were followed up for 12 months. The suggested starting dose of sacubitril/valsartan was 24/26 mg b.i.d. replacing angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, with an uptitration to 97/103 mg b.i.d. or as per clinical
JACC: Heart Failure, 2019
Objective: Our objective is to describe the short-term, health status benefits of ARNI initiation in patients with heart failure and reduced ejection fraction (HFrEF). Background: While sacubitril/valsartan, a neprilysin inhibitor (ARNI), improved patients' health status (compared with enalapril) at 8 months in PARADIGM-HF, the early impact of ARNI on patients' symptoms, function and quality of life is unknown. Methods: Health status was assessed with the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) in 3,918 outpatients with HFrEF (LVEF ≤ 40%) across 140 US centers in the CHAMP-HF registry. ARNI was initiated in 508 patients, who were matched 1:2 to 1,016 patients not started on ARNI (no-ARNI) using a non-parsimonious time-dependent propensity