What is the efficacy of macitentan for the treatment of pulmonary arterial hypertension (PAH)?

Updated: Apr 25, 2018
  • Author: Kristin E Schwab, MD; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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Answer

Macitentan is a dual endothelin receptor antagonist that prevents binding of ET1 to both EtA and EtB receptors. It is indicated to delay disease progression of PAH (WHO group I) and was approved by the FDA in October 2013. In the SERAPHIN trial (Study with an Endothelin Receptor Antagonist in Pulmonary Arterial Hypertension to Improve Clinical Outcome), macitentan was shown to lower the risk of clinical events in patients with PAH. According to the study, macitentan given at 10 mg/day led to a 45% reduction (P<.001) in a clinical primary endpoint that included death, initiation of intravenous or subcutaneous prostanoids, or worsening of PAH. The benefit was driven primarily by reductions in PAH worsening. A dosage of 3 mg/day was also shown to improve clinical outcome (P =.01) but to a lesser degree. [56, 57, 58] Anemia was observed in 4% of trial participants; LFT abnormalities were not noted.


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