Drug updated on 4/24/2024
| Dosage Form | Tablet (oral; 10mg) |
| Drug Class | Endothelin 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
- 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 Title | Year | Source |
|---|---|---|
| Opsumit (macitentan) Prescribing Information. | 2023 | Actelion Pharmaceuticals US, Inc., Titusville, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Canadian Cardiovascular Society/Canadian Thoracic Society position statement on pulmonary hypertension. | 2020 | Canadian Journal of Cardiology |
| Therapy for pulmonary arterial hypertension in adults: update of the CHEST guideline and expert panel report. | 2019 | Chest |
| Paediatric pulmonary arterial hypertension: updates on definition, classification, diagnostics and management. | 2019 | The European Respiratory Journal |