RT Journal Article
SR Electronic
T1 Effect of macitentan on haemodynamics in SERAPHIN, a randomised controlled trial in pulmonary arterial hypertension (PAH)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P4060
VO 42
IS Suppl 57
A1 Olivier Sitbon
A1 Richard Channick
A1 Marion Delcroix
A1 Nazzareno Galiè
A1 Hossein-Ardeschir Ghofrani
A1 Pavel Jansa
A1 Franck-Olivier Le Brun
A1 Sanjay Mehta
A1 Loïc Perchenet
A1 Tomás Pulido
A1 B.K.S. Sastry
A1 Rogério Souza
A1 Adam Torbicki
A1 Lewis Rubin
A1 Gérald Simonneau
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P4060.abstract
AB Macitentan's effect on haemodynamics in PAH patients was assessed at selected centres in the SERAPHIN study (NCT00660179). 742 patients were randomised to placebo, macitentan 3 or 10mg q.d. Background phosphodiesterase-5 inhibitors and oral/inhaled prostanoids were allowed. 187 patients had right heart catheterisation at randomisation and Month 6. Placebo (n=68), macitentan 3mg (n=62) and 10mg (n=57) groups were well balanced for baseline haemodynamics with median pulmonary vascular resistance (PVR), 800, 785, 789 dyn·sec/cm5 and cardiac index (CI) 2.49, 2.23, 2.47 L/min/m2. On average, all cardiopulmonary haemodynamics improved at Month 6 with macitentan and worsened with placebo. Subgroup analyses by background PAH therapy (naïve or treated) and baseline WHO FC I/II or III/IV showed that beneficial treatment effects with macitentan remained almost entirely significant for PVR and CI.View this table:Treatment effect on PVR (%)* and CI (L/min/m2)Macitentan improved cardiopulmonary haemodynamics in PAH patients with consistent improvements in PVR and CI irrespective of background PAH therapy and baseline WHO FC.