Why the study?
Does long-term treatment with macitentan reduce the risk of mortality and morbidity in patients with pulmonary arterial hypertension?
Does long-term treatment with macitentan reduce the risk of mortality and morbidity in patients with pulmonary arterial hypertension?
In the largest and longest PAH trial to date, macitentan significantly reduced the composite risk of morbidity and mortality, primarily driven by a reduction in PAH worsening.
May support macitentan in PAH to cut morbidity risk; leaves open need for real-world confirmation beyond this review.
Major limitations of pulmonary arterial hypertension (PAH) drug trials include the small number of enrolled patients, short term follow up (12-16 weeks), and lack of morbidity and mortality primary endpoints. The recently published SERAPHIN (Study with an Endothelin Receptor Antagonist in Pulmonary arterial Hypertension to Improve cliNical outcome) trial represents an important landmark in the history of clinical trials in PAH being the largest and longest clinical study conducted thus far in PAH patients with morbidity and mortality events as primary endpoint. SERAPHIN trial investigated whether long-term treatment with the new endothelin receptor antagonist macitentan would reduce the risk of mortality and morbidity in PAH patients.
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Karim Said (2014) studied this question.
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