Macitentan, a new dual endothelin receptor antagonist, is safe and well-tolerated for use in treating adult patients with pulmonary arterial hypertension (PAH), according to a real-world evidence study published in Drugs—Real World Outcomes. 

Macitentan is a novel dual endothelin receptor antagonist approved by the US Food and Drug Administration in 2013 for treating adult patients with PAH. It was also approved for use in Korea in 2014, both as a standalone drug and in combination with other therapies. Studies previously conducted on the safety and efficacy of this drug consisted of relatively small patient populations. 

The authors of the current study investigated the safety and clinical outcomes of macitentan in patients with PAH and identified any potential adverse events of concern. The prospective study was conducted from November 2014 to November 2020 in 50 healthcare centers in Korea. Adult patients 18 years of age and older with PAH were eligible for this study. 

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Recruited participants (n=474) were reviewed during the first prescription of macitentan (visit 1) and periodically every few weeks until week 24. All participants received macitentan oral tablets at a dose of 10 mg daily. The primary clinical outcome was World Health Organization functional class. 

Read more about PAH etiology

“Macitentan was well tolerated and significantly effective without any new safety concerns during the 24-week follow-up period after macitentan initiation,” the authors concluded.

The authors felt it was important to assess the safety and effectiveness of this drug in routine clinical practice given that participants recruited in previous studies may not have been representative of patients in a real-world setting. They also suggested that future studies should investigate the long-term safety profile and effectiveness of macitentan. 

PAH is characterized by an abnormal rise in pulmonary arterial pressure and vascular resistance. Common signs and symptoms include dyspnea, fatigue, chest pain, and palpitations. 


Jung SY, Chang SA, Song JM, et al. Real-world safety and clinical outcomes of macitentan in Asian patients with pulmonary arterial hypertension: a prospective multicenter study. Drugs Real World Outcomes. 2022;10.1007/s40801-022-00330-6. doi:10.1007/s40801-022-00330-6