CHEST Guidelines-Macitentan-Improves-Health-Related-Quality of

Macitentan-Improves-Health-Related-Quality of

Pdf Summary

The SERAPHIN trial evaluated the impact of macitentan, an endothelin receptor antagonist, on the health-related quality of life (HRQoL) in patients with pulmonary arterial hypertension (PAH). PAH is a progressive condition that significantly impairs patients’ physical, social, emotional, and psychological well-being, with its severity comparable to other chronic diseases like COPD and renal failure.<br /><br />In the study, 742 patients were randomized to receive either placebo, macitentan 3 mg, or macitentan 10 mg daily. Changes in HRQoL were assessed using the 36-Item Short Form Survey (SF-36), which measures physical and mental health. At the six-month mark, the 10 mg dose of macitentan significantly improved seven of the eight SF-36 domains and both the physical and mental component summary scores compared to placebo. Additionally, patients on macitentan 10 mg had a significantly reduced risk of a three-point or greater deterioration in these scores over the long term. It was also found that a better baseline HRQoL was associated with a lower risk of morbidity and mortality events.<br /><br />This study is significant because it provides evidence that macitentan not only improves clinical outcomes but also enhances HRQoL in PAH patients. The findings support the inclusion of HRQoL as an important outcome measure in clinical trials for PAH therapies. They also highlight the potential long-term benefits of macitentan in maintaining HRQoL, offering an advantage over other PAH treatments that may have more burdensome administration or greater side effects.<br /><br />The study's design, which included diverse international sites and long-term follow-up, strengthens the validity of the findings, although limitations such as missing data at later time points and the use of a generic HRQoL measure were noted. Nonetheless, the trial's results advocate for the continued use of macitentan in PAH patients to improve their overall quality of life and potentially enhance long-term health outcomes.

Keywords

SERAPHIN trial

macitentan

endothelin receptor antagonist

pulmonary arterial hypertension

HRQoL

SF-36 survey

clinical outcomes

long-term benefits

morbidity and mortality

international study