Abstract 17912: Health-related Quality of Life Outcomes in PARADIGM-HF
Bibliographic record
Abstract
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".