Abstract
Macitentan's effect on 6MWD and the association between 6MWD and the long-term outcome of PAH-related death or hospitalisation (PAHDH) were explored in SERAPHIN (NCT00660179) where 742 PAH patients were randomised to placebo, macitentan 3 or 10mg q.d. Repeated measures analysis was performed on 6MWD changes from baseline (BL) at Months 3, 6, 12. In patients with available data for 6MWD at Month 6, hazard ratios measured associations between interquartile ranges of BL 6MWD, 6MWD changes, or Month 6 values (±adjustment for significant covariates) and the risk of PAHDH from Month 6. 6MWD benefit was sustained with macitentan vs placebo over 12 months (3mg: +21.5m [95%CI 10.0–33.0]; P=0.0003 and 10mg: +25.4m [95%CI 13.8–37.0]; P<0.0001). Lower BL 6MWD and Month 6 values were associated with PAHDH risk. Absolute value at Month 6 lost its association when adjusted for BL 6MWD and sex. Neither adjusted nor non-adjusted changes in 6MWD from BL to Month 6 were associated with PAHDH risk.
- © 2013 ERS