#PARALLAX MENU ACTIVE INDICATION PRO#
#PARALLAX MENU ACTIVE INDICATION TRIAL#

Overall, except for heart failure events, serious adverse events were reported in similar proportions of patients in both groups. Changes in NYHA class were similar in both groups at week 24. Quality of life improved in both groups and was better with sacubitril/valsartan than the comparator at week 4 but there was no difference between groups at week 24. Secondary endpoints included change from baseline to 24 weeks in quality of life (measured by the Kansas City Cardiomyopathy Questionnaire KCCQ) and New York Heart Association (NYHA) functional class.

The trial did not meet the second primary endpoint: at week 24, six-minute walk distance had improved in both groups compared to baseline (mean change was 9.7 m in the sacubitril/valsartan group and 12.2 m in the individualised medical therapy group), with no significant difference between groups (mean difference -2.5 m 95% confidence interval -8.5 to 3.5 m p=0.79). The trial met the first primary endpoint: after 12 weeks, patients treated with sacubitril/valsartan showed a highly significant 16.4% greater reduction in NT-proBNP than patients treated with optimal individualised medical therapy (p<0.0001). The mean left ventricular ejection fraction at baseline was 56%.

Patients in the trial had a mean age of 73 years and 51% were women.

The co-primary endpoints were chosen to assess heart failure severity and functional capacity: 1) change from baseline to 12 weeks in plasma N-terminal pro B-type natriuretic peptide (NT-proBNP) and 2) change in six-minute walk distance from baseline to 24 weeks.ДЄ total of 2,572 HFpEF patients were randomly allocated to sacubitril/valsartan or their current RAS medication (enalapril, valsartan or placebo if they were not taking a RAS inhibitor).

PARALLAX therefore tested the effects of sacubitril/valsartan versus optimal individualised background therapy, which could be the ACE inhibitor enalapril, the ARB valsartan, or placebo. Many take an ACE inhibitor, and some no RAS inhibitor at all. 2 However, in daily practice, not all HFpEF patients receive an ARB. The PARAGON-HF outcome trial suggested that sacubitril/valsartan may reduce heart failure hospitalisations in HFpEF patients compared to valsartan (an ARB). Treatment recommendations mainly focus on symptom relief with diuretics and treating comorbidities, typically with inhibitors of the renin-angiotensin system (RAS) including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). There is currently no approved therapy to reduce morbidity and mortality in patients with HFpEF. Patients are often highly symptomatic, with shortness of breath, reduced ability to exercise, impaired quality of life, and frequent rehospitalisations. Prevalence is expected to rise with the ageing population and increased rates of risk factors such as hypertension, diabetes, obesity and atrial fibrillation. Heart failure with preserved ejection fraction (HFpEF) affects approximately half of patients with heart failure. ThatвЂ™s the main finding of the PARALLAX trial presented in a Hot Line session today at ESC Congress 2020. Sophia Antipolis, France вЂ“ : Sacubitril/valsartan reduces NT-proBNP, a biomarker predictive of long-term clinical outcomes in heart failure, but does not improve functional capacity compared to individualised background therapy in patients with heart failure with preserved ejection fraction.

#PARALLAX MENU ACTIVE INDICATION TRIAL#

#PARALLAX MENU ACTIVE INDICATION PRO#

Parallax menu active indication