What would it mean for your HFrEF patients to feel better?
PARADIGM-HF evaluated patients' overall quality of life (QoL) using the KCCQ-23, which includes these domains1,2:
Physical limitation
Symptom frequency
Symptom burden
Symptom stability
Self-efficacy
Social limitation
QoL
Each domain is scored on a scale of 0-100; higher scores indicate better health status.
The KCCQ-23 Clinical Summary score (CS) represents the average of the symptom (frequency and burden) and physical limitation domains.1,2
Analysis included all patients with at least 1 KCCQ data up to month 8. For patients who died, the worst score (0) was imputed for the CS at all subsequent scheduled visits.
Patients on ENTRESTO® experienced 35% less decline in health-related QoL vs an ACEi2
Change in the KCCQ-23 CS from baseline to 8 months was a prespecified secondary outcome in PARADIGM-HF.1,3
Mean change in KCCQ-23 CS at 8-month, double-blind period: ENTRESTO -2.99 (n=4187), enalapril -4.63 (n=4212). Clinically meaningful difference established as 5 points.3
PARADIGM-HF: KCCQ-23 analysis limitations2
Baseline KCCQ-23 CS in the overall PARADIGM-HF population was assessed at randomization. This may have resulted in higher baseline scores due to treatment during the run-in phase. Limited data exist assessing clinical meaningfulness of change scores in patients with relatively good baseline perceptions of HRQoL
Statistical analysis suggests that the difference between ENTRESTO and enalapril treatment arms may have been driven in part by the treatment effect on HF hospitalizations
KCCQ-23 tool limitations1,2
2-week recall period
Missing scores in physical limitation domain due to conditions other than HF
*In PARAGON-HF, defined as LVEF ≥45% with structural heart disease (LAE or LVH); median LVEF was 57%. LVEF is a variable measure and the normal range can vary.4