Table 2.
Primary and secondary end points for events related to PAH in the SERAPHIN study
| Placebo n=250 n (%) | Macitentan 3 mg n=250 n (%) | Macitentan 10 mg n=242 n (%) | Macitentan 3 mg vs placebo HR (97% CI) | Macitentan 10 mg vs placebo HR (97% CI) | |
|---|---|---|---|---|---|
| Primary endpoint | |||||
| Composite of event related to PAH or death from any cause | |||||
| All events | 116 (46.4) | 95 (38) | 76 (31.4) | 0.70 (0.52–0.96)* | 0.55 (0.32–0.76)* |
| Worsening PAH | 93 (37.2) | 72 (28.8) | 59 (24.4) | ||
| Death from any causea | 17 (6.8) | 21 (8.4) | 16 (6.6) | ||
| Prostanoid initiation | 6 (2.4) | 1 (0.4) | 1 (0.4) | ||
| Lung transplantation | 0 | 1 (0.4) | 0 | ||
| Secondary endpoint | |||||
| Composite of death due to PAH or hospitalization due to PAH | |||||
| All events | 84 (33.6) | 65 (26) | 50 (20.7) | 0.67 (0.46–0.97)* | 0.50 (0.34–0.75)* |
| Hospitalization for PAH | 79 (31.6) | 56 (22.4) | 45 (18.6) | ||
| Death due to PAHb | 5 (2.0) | 9 (3.6) | 5 (2.1) | ||
| Death from any cause | 19 (7.6) | 21 (8.4) | 14 (5.8) | 0.97 (0.48–1.98) | 0.64 (0.29–1.42) |
| Death due to PAHc | 14 (5.6) | 14 (5.6) | 7 (2.9) | 0.87 (0.37–2.04) | 0.44 (0.16–1.25) |
| Death from any cause by end of studyd | 44 (17.6) | 47 (18.8) | 35 (14.5) | 1.05 (0.65–1.67) | 0.77 (0.46–1.28) |
Notes:
Denotes P<0.05.
Intention to treat analysis, four patients in the interventional arms had adverse events, discontinued the treatment and died thereafter.
Data do not include patients who were hospitalized before death.
Death adjudicated to be due to PAH and that occurred during the double-blind period or death that occurred within 4 weeks after the end of treatment, after a confirmed worsening of PAH.
Analysis included patients who were eligible to receive other treatment for PAH, including open-label macitentan at a dose of 10 mg. Data from Pulido et al.42
Abbreviations: CI, confidence interval; HR, hazard ratio; PAH, pulmonary arterial hypertension; SERAPHIN, Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome.