Key result
Macitentan 10 mg once daily maintained improvements in 6-minute walk distance, WHO functional class, and NT-pro-BNP levels over a median of 2.4 years in Japanese patients with PAH.
Why the study?
Macitentan was approved for the treatment of PAH in Japan, but its long-term effects in Japanese patients were currently unavailable.
Does long-term treatment with macitentan improve exercise capacity, functional class, and biomarkers in Japanese patients with pulmonary arterial hypertension?
Does long-term treatment with macitentan improve exercise capacity, functional class, and biomarkers in Japanese patients with pulmonary arterial hypertension?
Long-term macitentan therapy is well tolerated and maintains improvements in exercise capacity, functional class, and biomarkers in Japanese patients with pulmonary arterial hypertension.
May support long-term macitentan maintenance in Japanese PAH; leaves open generalizability beyond this observational cohort.
Objective Macitentan, a novel dual endothelin receptor antagonist, was approved for the treatment of pulmonary arterial hypertension (PAH) in Japan. However, long-term effects in Japanese patients of macitentan are currently unavailable. This study sought to assess the long-term efficacy and safety of macitentan in Japanese patients with PAH.Methods In this multicenter, open-label, clinical extension study (JapicCTI-121986), efficacy was evaluated based on the change from baseline at 24, 48, 72, 96 and 120-week in the 6-minute walk distance (6MWD), World Health Organization (WHO) functional class, and serum N-terminal pro-brain natriuretic peptide (NT-pro-BNP) levels. In addition, the time to a hospitalization related to PAH and a morbidity/mortality event was determined. As for safety, the incidence of adverse events and changes in laboratory data and vital signs were assessed.Results Macitentan was administered at a once-daily dose of 10 mg in 30 PAH patients with a median treatment period of 2.4 years (range, 229–1037 days). The improvements in 6MWD, WHO functional class and NT-pro-BNP at week 24 were maintained throughout the long-term follow-up. Hospitalization related to PAH occurred in 2 patients. Levels of liver enzyme and hemoglobin remained unchanged throughout the study period.Conclusions This study suggests that the long-term use of macitentan is well tolerated and effective in Japanese patients with PAH. We concluded that macitentan can be a possible approach to reduce morbidity/mortality in Japanese PAH patients.
No takes yet. Share an insight, caveat, or question.
Tahara et al. (2020) studied pulmonary arterial hypertension (PAH) (n=30). Macitentan was evaluated on Change from baseline at 24, 48, 72, 96 and 120-week in the 6-minute walk distance (6MWD), WHO functional class, and serum NT-pro-BNP levels. Macitentan 10 mg once daily maintained improvements in 6-minute walk distance, WHO functional class, and NT-pro-BNP levels over a median of 2.4 years in Japanese patients with PAH.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: