At week 24, there was no significant between-group difference in median change from baseline in the 6-minute walk distance with an increase of 9.7 m vs 12.2 m (adjusted mean difference, −2.5 m 95% CI, −8.5 to 3.5 P = .42).
After 12 weeks, patients in the sacubitril/valsartan group (adjusted geometric mean ratio to baseline, 0.82 pg/mL) had a significantly greater reduction in NT-proBNP levels than did those in the comparator group (adjusted geometric mean ratio to baseline, 0.98 pg/mL) with an adjusted geometric mean ratio of 0.84 (95% CI, 0.80 to 0.88 P < .001). At baseline, the median NT-proBNP levels were 786 pg/mL in the sacubitril/valsartan group and 760 pg/mL in the comparator group.
Results Among 2572 randomized patients (mean age, 72.6 years 1301 women ), 2240 (87.1%) completed the trial. Secondary end points were change from baseline in quality of life measures and New York Heart Association (NYHA) class at 24 weeks. Main Outcomes and Measures Primary end points were change from baseline in plasma NT-proBNP level at week 12 and in the 6-minute walk distance at week 24. Interventions Patients were randomized 1:1 either to sacubitril/valsartan (n = 1286) or to background medication–based individualized comparator (n = 1286), ie, enalapril, valsartan, or placebo stratified by prior use of a renin angiotensin system inhibitor. Of 4632 patients screened at 396 centers in 32 countries, 2572 patients with heart failure, LVEF of more than 40%, elevated NT-proBNP levels, structural heart disease, and reduced quality of life were enrolled (last follow-up, October 28, 2019).
#Parallax fitness trial
Objective To evaluate the effect of sacubitril/valsartan on N-terminal pro–brain natriuretic peptide (NT-proBNP) levels, 6-minute walk distance, and quality of life vs background medication–based individualized comparators in patients with chronic heart failure and LVEF of more than 40%.ĭesign, Setting, and Participants A 24-week, randomized, double-blind, parallel group clinical trial (August 2017-October 2019). Importance There is limited evidence on the benefits of sacubitril/valsartan vs broader renin angiotensin system inhibitor background therapy on surrogate outcome markers, 6-minute walk distance, and quality of life in patients with heart failure and mildly reduced or preserved left ventricular ejection fraction (LVEF >40%).
The analysis includes data observed up to week 12. The mixed model for the repeated-measures model includes stratum angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), no renin angiotensin system inhibitors, region, treatment (sacubitril/valsartan, background medication–based individualized comparators), visit, treatment × visit interaction, subgroup, subgroup × visit interaction, treatment × subgroup interaction, and treatment × subgroup × visit interaction as fixed-effect factors baseline log-transformed N-terminal pro–brain natriuretic peptide (NT-proBNP), stratum × baseline log-transformed NT-proBNP, and visit × baseline log-transformed NT-proBNP interactions as covariates and models the within-patient covariance using an unstructured covariance matrix (a common matrix for the 2 treatment groups). The interaction P value is for the subgroup variable × the treatment interaction at week 12. An adjusted geometric mean ratio lower than 1 favors sacubitril/valsartan.
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