Abstract 17912: Health-related Quality of Life Outcomes in PARADIGM-HF
Introduction: Heart failure with reduced ejection fraction (HF) patients have impaired health-related quality of life (HRQL) with variable responses to therapies that target mortality and HF hospitalizations. In PARADIGM-HF, LCZ696 reduced morbidity and mortality compared with enalapril. Prior analysis demonstrated a significant difference in 8-month Kansas City Cardiomyopathy-Clinical Summary score (KCCQ-CSS) when imputing 0 for death (-2.99 vs. -4.63, p=0.0014). Given improvements in mortality with LCZ696, this analysis provides impact of therapy on all domains of HRQL in survivors only.
Hypothesis: LCZ696 will improve HRQL
Methods: Patients (after run-in phase) completed disease-specific KCCQ at randomization, 4 month, 8 month, and annual visits. Changes in KCCQ scores were calculated using repeated measures ANCOVA model adjusting for treatment, region, & baseline values (primary efficacy pre-specified at 8 months), and association of KCCQ with mortality was assessed.
Results: Among 8442 patients enrolled in PARADIGM-HF, 7623 (90%) completed KCCQ scores at randomization with complete data at 8 months on 7281 (86%). Baseline KCCQ scores were similar in LCZ696 and enalapril groups (73.5±20 vs. 72.3±19). Death increased with every 10 point decrement of baseline KCCQ-CSS [HR 1.11 (1.09, 1.14)]. At 8 months, LCZ696 group noted improvements in both KCCQ-CSS (+0.61 vs. -0.28, p=0.010) and KCCQ-Overall summary score (+1.10 vs. -0.15, p<0.001) in comparison to enalapril group with consistent trends in most KCCQ domains (Table). Adjusted change scores demonstrated consistent improvements in LCZ696 compared with enalapril through 36 months.
Conclusions: Disease-specific HRQL is associated with survival. Changes in HRQL were better in patients treated with LCZ696 compared with enalapril with consistency in most domains. These findings suggest that LCZ696 leads to better HRQL in addition to morbidity & mortality in HF-reduced ejection fraction patients.
Author Disclosures: E. Lewis: Research Grant; Significant; Novartis, Amgen, Sanofi. M.R. Zile: Research Grant; Significant; Novartis. K. Swedberg: Research Grant; Significant; Novartis. J.L. Rouleau: Research Grant; Significant; Novartis. B. Claggett: None. M.P. Lefkowitz: Employment; Significant; Novartis. V.C. Shi: Employment; Significant; Novartis. S.D. Solomon: Research Grant; Significant; Novartis. M. Packer: Research Grant; Significant; Novartis. J.J. McMurray: Research Grant; Significant; Novartis.
- © 2015 by American Heart Association, Inc.