- 著者
- 
             
             Tohru Satoh
             
             Tsutomu Saji
             
             Hiroshi Watanabe
             
             Satoshi Ogawa
             
             Kazuhiko Takehara
             
             Nobuhiro Tanabe
             
             Norikazu Yamada
             
             Atsushi Yao
             
             Katsumasa Miyaji
             
             Norifumi Nakanishi
             
             Yumiko Suzuki
             
             Tadami Fujiwara
             
             Takayuki Kuriyama
             
          
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- vol.75, no.3, pp.677-682, 2011 (Released:2011-02-25)
- 参考文献数
- 28
- 被引用文献数
- 
             
             13
             
             
             11
             
             
          
        
        Background: There is evidence that phosphodiesterase type-5 is effective for the treatment of pulmonary arterial hypertension (PAH). Methods and Results: A phase III, multicenter, open-label clinical trial of sildenafil 20mg t.i.d. was conducted in 21 Japanese patients with PAH to examine its efficacy, safety, and pharmacokinetics. The present trial consisted of a screening period and 12-week treatment. Patients who were enrolled in the present trial increased their 6-min walking distance of administration increased at week 12 by 84.2m from baseline. Hemodynamic parameters (eg, mean pulmonary artery pressure and pulmonary vascular resistance), Borg dyspnea scores, and plasma brain natriuretic peptide concentrations also improved compared to baseline. Most patients improved or sustained WHO functional class. Seven subjects, who were examined for the pharmacokinetics of sildefanil, showed relatively large interindividual variations in the Cmax, AUC0-8, Css,av, and Ctrough of the drug. Any serious adverse events, severe adverse events, and deaths were not observed. Most of events of undeniable causality were mild or moderate in severity. Sildefanil was well tolerated by the subjects. Conclusions: Sildenafil 20mg t.i.d. was effective and safe for Japanese patients with PAH. (Circ J 2011; 75: 677-682)