A study has evaluated the effect of Macitentan ( Opsumit ) on hospitalization of patients with symptomatic pulmonary arterial hypertension ( PAH ).
PAH is a progressive, life-threatening disease often requiring hospitalization.
In the multicenter, double-blind, randomized, event-driven, phase III SERAPHIN ( Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome ) trial, patients with symptomatic pulmonary arterial hypertension were randomized ( 1:1:1 ) to receive placebo or 3 mg or 10 mg of Macitentan.
Effects of Macitentan on the risk, rate, and number of hospital days for all-cause and PAH-related hospitalizations were compared with those for placebo.
Risk and causes of hospitalizations unrelated to pulmonary arterial hypertension were investigated.
Of 742 randomized patients, 250 received placebo, 250 received 3 mg of Macitentan, and 242 received 10 mg of Macitentan; the overall median duration of treatment was 115 weeks.
Risk of all-cause hospitalization was reduced by 18.9% ( p = 0.1208 ) and 32.3% ( p = 0.0051 ) in the Macitentan 3-mg and 10-mg arm, respectively.
Rates of all-cause hospitalizations and numbers of hospital days were reduced by 20.5% ( p = 0.0378 ) and 30.6% ( p = 0.0278 ), respectively, with 3 mg of Macitentan and by 33.1% ( p = 0.0005 ) and 31.0% ( p = 0.0336 ), respectively, with 10 mg of Macitentan.
Risk of PAH-related hospitalizations were reduced by 42.7% ( p = 0.0015 ) and 51.6% ( p less than 0.0001 ) in the Macitentan 3-mg and 10-mg arms, respectively.
Rate of PAH-related hospitalizations and numbers of hospital days were reduced by 44.5% ( p = 0.0004 ) and 53.3% ( p = 0.0001 ), respectively, with 3 mg of Macitentan, and reduced by 49.8% ( p less than 0.0001 ) and 52.3% ( p = 0.0003 ), respectively, with 10 mg of Macitentan.
Risk of non-PAH-related hospitalization was similar between treatment arms.
In conclusion, Macitentan 10 mg significantly reduced the risk and rate of all-cause hospitalization, which was driven by reductions in the risk and rate of PAH-related hospitalization. ( Xagena )
Channick RN et al, JACC Heart Fail 2014; Epub ahead of print