PT - JOURNAL ARTICLE AU - Pavel Jansa AU - Richard Channick AU - Marion Delcroix AU - Nazzareno Galiè AU - Hossein-Ardeschir Ghofrani AU - Elke Hunche AU - Sanjay Mehta AU - Camilla Mittelholzer AU - Tomás Pulido AU - B.K.S. Sastry AU - Olivier Sitbon AU - Rogério Souza AU - Adam Torbicki AU - Gérald Simonneau AU - Lewis Rubin TI - Impact of macitentan on the health-related quality of life (HRQoL) in pulmonary arterial hypertension (PAH): Results from a long-term randomised controlled trial DP - 2013 Sep 01 TA - European Respiratory Journal PG - P4075 VI - 42 IP - Suppl 57 4099 - http://erj.ersjournals.com/content/42/Suppl_57/P4075.short 4100 - http://erj.ersjournals.com/content/42/Suppl_57/P4075.full SO - Eur Respir J2013 Sep 01; 42 AB - The impact of macitentan, a novel endothelin receptor antagonist, on HRQoL was assessed in patients enrolled in the SERAPHIN study (randomised 1:1:1 to placebo, macitentan 3 or 10mg q.d.). Literate PAH patients (≥14 years), in WHO functional class II–IV, answered the Short Form 36-item (SF-36v2) at baseline, 6 and 12 months, and end-of-treatment (EOT). Placebo-corrected treatment effects for change from baseline to Month 6 and 12 are reported for the physical (PCS) and mental component summary (MCS) scores of the SF-36, with missing data imputed. Kaplan–Meier analyses of the time to a ≥5-point decrease (considered clinically relevant) from baseline in the PCS and MCS scores up to EOT were performed. Treatment groups were compared using log rank tests. Both doses of macitentan showed significant treatment effects vs placebo on the PCS and MCS at 6 and 12 months.View this table:Placebo-corrected treatment effect (mean [95% CI]) on PCS and MCS*Both doses reduced the risk of HRQoL deterioration, as measured by the time to ≥5-point decrease in the PCS (3mg: HR 0.70, 95%CI 0.54–0.92, P=0.008; 10mg: HR 0.65, 95%CI 0.50–0.85, P=0.001) and the MCS scores (3mg: HR 0.81, 95%CI 0.63–1.03, P=0.085; 10mg: HR 0.79, 95%CI 0.61–1.01, P=0.053) across the total study duration. In conclusion, macitentan improved HRQoL scores vs placebo and reduced the risk of decline in HRQoL over the duration of SERAPHIN.