Drug updated on 12/11/2024
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.
Latest News
Summary
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Macitentan demonstrated a significant improvement in 6-Minute Walk Distance (6MWD) with a mean difference (MD) of 34.00 (95% confidence interval (CI): 3.50; 64.50) compared to placebo, while the switch from Bosentan/Ambrisentan to Macitentan yielded an improvement of 20.71 m (95% CI: 10.35-31.07).
- In patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension (CTD-PAH), macitentan showed favorable effects on clinical and hemodynamic outcomes without impacting survival, while in Chronic Thromboembolic Pulmonary Hypertension (CTEPH), it benefited pulmonary vascular resistance and clinical worsening.
- The use of macitentan in both pediatric and adult PAH patients following a switch from Bosentan/Ambrisentan was associated with improvements in tricuspid annular plane systolic excursion, indicating its effectiveness across different age groups and underlying conditions.
- Macitentan was associated with adverse events including headache, anemia, and bronchitis. The reported risk of adverse effects was comparable to other DPP4 inhibitors, with no significant increase in severe adverse events (relative risk (RR) 1.75; 95% CI 0.90-3.40).
- Macitentan exhibited a lower incidence of clinical worsening compared to other treatments; specifically, treatment with macitentan resulted in fewer hospitalizations and less clinical deterioration than seen with treprostinil, riociguat, and placebo.
- In patients with CTD-PAH, macitentan showed favorable effects on clinical and hemodynamic outcomes, although survival benefits were not observed. In patients with CTEPH, macitentan demonstrated benefits in reducing pulmonary vascular resistance and clinical worsening. Additionally, a switch from Bosentan/Ambrisentan to Macitentan resulted in improved tricuspid annular plane systolic excursion in both pediatric and adult populations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Opsumit (macitentan) Prescribing Information. | 2019 | Actelion Pharmaceuticals US, Inc., South San Francisco, CA |
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 |