Macitentan: a guide to its use in the treatment of pulmonary arterial hypertension in adults of WHO functional class II or III in the EU

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Macitentan (Opsumit®), a novel dual endothelin receptor antagonist, is indicated (as monotherapy or in combination) for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II or III. In a key clinical trial, oral macitentan 10 mg once daily reduced the risk of a composite morbidity–mortality endpoint, reduced the risk of death due to PAH or hospitalization for PAH, and improved other PAH-related outcomes and health-related quality of life. The efficacy of macitentan 10 mg on the composite morbidity–mortality endpoint was consistent across subgroups of age, ethnic origin, geographical region, by monotherapy or in combination with another PAH therapy and by WHO FC (I/II and III/IV). Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease. Macitentan is generally well tolerated.

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