Table 1.
Long‐term clinical outcomes from CHAMPION trial Randomized Access Period35
| Treatment group (n = 270) | Control group (n = 280) | ||
|---|---|---|---|
| Heart failure hospitalizations, n (events/patient‐year) | 182 (0.46) | 279 (0.68) | Diff 97 (0.23), NNT 4, HR 0.67 (33% RRR) (95% CI 0.55–0.80), P < 0.0001a |
| Non heart failure hospitalizations, n (events/patient‐year) | 372 (0.93) | 393 (0.96) | Diff 21 (0.03), HR 0.97 (3% RRR) (95% CI 0.84–1.12), P = 0.6790a |
| Death, n (%) | 50 (18.5%) | 64 (22.9%) | Non‐significant, HR 0.80 (95% CI 0.55–1.15), P = 0.23b |
| EQ‐5D‐3 L utilities (US preference weights) | |||
| Baseline | 0.711 | ||
| 6 months | 0.719 | 0.681 | P = 0.056c |
| 12 months | 0.739 | 0.660 | P = 0.003c |
NNT, number needed to treat; RRR, relative risk reduction.
a
Hazard ratio (HR), 95% confidence interval (CI), and P‐value from the Andersen–Gill model.
b
HR and 95% CI from the Cox proportional hazards model, P‐value from log‐rank test.
c
P‐value from two‐sided Wilcoxon test.