Long-term treatment of pulmonary arterial hypertension with macitentan in Japanese patients. (2nd June 2020)

• Record Type: Journal Article
• Authors: Tahara, Nobuhiro; Dobashi, Hiroaki; Fukuda, Keiichi; Funauchi, Masanori; Hatano, Masaru; Ikeda, Satoshi; Joho, Shuji; Kihara, Yasuki; Kondo, Takahisa; Matsushita, Masakazu; Minamino, Tohru; Nakanishi, Norifumi; Okano, Yoshiaki; Ozaki, Yukio; Saji, Tsutomu; Sakai, Satoshi; Tanabe, Nobuhiro; Watanabe, Hiroshi; Yamada, Hidehiro; Yoshioka, Koichiro; Hatta, Motonori; Sasayama, Shigetake
• Is Part Of: Current medical research and opinion. Volume 36:Number 6(2020)
• Page Start: 921
• Page End: 928
• Publication Date: 2020-06-02
• Subjects: Pulmonary arterial hypertension -- endothelin receptor antagonist -- macitentan -- long-term treatment -- efficacy and safety; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2020.1756234
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: 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.