Summary

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• Opsumit (macitentan) is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to reduce the risks of disease progression and hospitalization for PAH.
• This summary is based on the review of eight systematic review(s)/meta-analysis(es). ^[1-8]
• A meta-analysis of 12 RCTs with 1,837 patients revealed significant improvements in functional class, 6MWD, clinical worsening, PVR, RAP, and CI with pharmacological interventions, including macitentan. However, there were no significant differences in short-term survival rates or NT-proBNP levels between intervention and control groups.
• In six RCTs involving 1,003 participants, macitentan significantly improved 6MWD (WMD 12.06 m), PVR (WMD -186.51 dyn·s/cm^-5), mPAP (WMD -3.20 mmHg), NT-proBNP (WMD -232.47 ng/L), and CI (WMD 0.39 L/min/m^2).
• Switching from Other ERAs to Macitentan in PAH patients: Nine studies with 408 PAH patients indicated that switching to macitentan from bosentan or ambrisentan increased 6MWD by 20.71 m and improved WHO functional class, with no significant change in NT-proBNP levels.
• In six RCTs involving 1,003 participants with pulmonary hypertension, macitentan was associated with higher risks of anemia (RR 3.86), headache (RR 1.52), and bronchitis (RR 2.24), with no significant differences in the occurrence of serious adverse events, all-cause death, or adverse events leading to discontinuation between macitentan and placebo groups.
• Among patients with Eisenmenger Syndrome treated with PAH-specific drug therapy, including macitentan, 4.3% experienced serious adverse events, and 3.9% experienced death. The adverse events were generally mild to moderate.
• Studies focused on specific populations, including patients with connective tissue diseases (systemic sclerosis, SLE) and Eisenmenger Syndrome, showed benefits from macitentan, especially in improving exercise capacity and hemodynamics. Improvements were also noted in both adult and pediatric PAH patients switching from other ERAs. However, macitentan is not recommended for patients with PH-LHD due to heart failure. No specific subgroup details were provided for the general PH population.