Macitentan

(Opsumit®)

Macitentan

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Drug updated on 4/24/2024

Dosage FormTablet (oral; 10mg)
Drug ClassEndothelin receptor antagonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.

Summary
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  • Macitentan (Opsumit) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I), reducing the risks of disease progression and hospitalization. It has shown significant benefits in terms of 6-Minute Walk Distance (6MWD) improvement, especially when switched from other endothelin receptor antagonists like bosentan and ambrisentan.
  • The review was based on eight systematic reviews/meta-analyses documents, providing a comprehensive overview focusing on macitentan's comparison with other drugs regarding safety and effectiveness.
  • In specific populations such as those with connective tissue disease-associated PAH (CTD-PAH), treatments including macitentan have provided favorable clinical outcomes, but survival rates were not significantly different from control groups. Its utility also extends to pediatric and adult populations, improving functional capacity when switching from other ERAs.
  • Long-term use safety analysis indicates that macitentan is generally safe for patients with PH despite higher risks for anemia, headache, and bronchitis. The occurrence rate of adverse events was not significantly different compared to placebo users, indicating a manageable safety profile over extended periods.
  • Compared to other therapeutic classes such as ERAs (bosentan, ambrisentan) and phosphodiesterase type 5 inhibitors (PDE5i), macitentan offers competitive or superior benefits in exercise capacity improvements along with hemodynamic enhancements.
  • For Pulmonary Hypertension associated with left heart disease (PH-LHD), caution is advised while using PAH-specific medications, including macitentan, reflecting the need for cautious application in distinct patient subgroups. However, beneficial outcomes are observed when switching therapies or used alongside tadalafil and treprostinil, emphasizing its role in combination therapy protocols.

Product Monograph / Prescribing Information

Document TitleYearSource
Opsumit (macitentan) Prescribing Information.2023Actelion Pharmaceuticals US, Inc., Titusville, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines