What were the results of the SERAPHIN trial on the treatment of idiopathic pulmonary arterial hypertension (IPAH)?

Updated: Jul 08, 2020
  • Author: Ronald J Oudiz, MD, FACP, FACC, FCCP; Chief Editor: Zab Mosenifar, MD, FACP, FCCP  more...
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Answer

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. Administration of macitentan at 10 mg/day led to a 45% reduction in a clinical primary endpoint that included death, initiation of intravenous or subcutaneous prostanoids, or worsening of PAH. Benefit was driven primarily by reductions in PAH worsening. A dosage of 3 mg/day also improved clinical outcome but to a lesser degree. [38, 39, 41, 40]

Combination therapy of ambrisentan (an ERA) with tadalafil (a PDE-5 inhibitor) was approved as first-line treatment by the FDA in October 2015. The combination decreased disease progression and hospitalization, and more effectively improved exercise ability. Approval of the first-line ambrisentan/tadalafil combination for PAH is based on results of the ambrisentan and tadalafil in patients with pulmonary arterial hypertension (AMBITION) trial involving 605 patients with World Health Organization functional class II or III PAH. Patients were randomly assigned to receive once-daily ambrisentan plus tadalafil or to either drug alone. Doses were titrated from 5-10 mg/day for ambrisentan and from 20-40 mg/day for tadalafil. Treatment with the combination was associated with ~50% reduction in risk for clinical failure compared with either drug alone (P = 0.0002). [42]


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