Rates of PAH-related hospitalisations and hospital inpatient days up to EOT in SERAPHIN
| Placebo N=249 | Macitentan 3mg N=250 | Macitentan 10mg N=242 | |
|---|---|---|---|
| PAH-related hospitalisations per year | |||
| Adjusted* annual rate per 100 patient-years (95% CL) | 27 (20–36) | 15 (11–21) | 12 (9–17) |
| Treatment effect vs placebo (95% CL) | 0.57 (0.38–0.86) | 0.45 (0.30–0.69) | |
| P-value | 0.0068 | 0.0002 | |
| PAH-related inpatient hospitalisation days per year | |||
| Adjusted* annual rate (95% CL) | 5.5 (3.3–9.0) | 3.7 (2.2–6.1) | 2.7 (1.6–4.4) |
| Treatment effect vs placebo (95% CL) | 0.67 (0.33–1.37) | 0.48 (0.24–0.97) | |
| P-value | 0.2707 | 0.0416 | |
↵* Adjusted in a negative binomial regression model for WHO functional class (I/II vs III/IV) and 6-minute walk distance at baseline (>380 m vs ≤380 m)
CL: confidence limit; PAH: pulmonary arterial hypertension