A Phase III, Multicenter, Collaborative, Open-Label Clinical Trial of Sildenafil in Japanese Patients With Pulmonary Arterial Hypertension
スポンサーリンク
概要
- 論文の詳細を見る
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)
著者
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TAKEHARA Kazuhiko
Department of Dermatology, Kanazawa University Hospital
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YAMADA Norikazu
Department of Cardiology, Mie University Graduate School of Medicine
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NAKANISHI Norifumi
Division of Cardiology, National Cardiovascular Center
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Watanabe Hiroshi
Department of Cardiology, Niigata City General Hospital
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SATOH Tohru
Department of Cardiology,Ashikaga Red Cross Hospital
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Ogawa Satoshi
Department Of Cardiology Keio University
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Kuriyama Takayuki
Department of Chest Medicine, School of Medicine, Chiba University
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Tanabe Nobuhiro
Department Of Respirology Chiba Graduate School Of Medicine
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Miyaji Katsumasa
Department Of Cardiology National Hospital Organization Okayama Medical Center
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Yao Atsushi
Department of Cardiovascular Medicine, University of Tokyo Graduate School of Medicine
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Saji Tsutomu
First Department of Pediatrics, Toho University Omori Medical Center
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Suzuki Yumiko
Tokyo Laboratories, Pfizer Global R&D, Pfizer Japan Inc
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Fujiwara Tadami
Tokyo Laboratories, Pfizer Global R&D, Pfizer Japan Inc
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