title: A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension.
abstract: BACKGROUND
  There is evidence that phosphodiesterase type-5 is effective for the treatment of pulmonary arterial hypertension (PAH).
  
  
  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 C(max), AUC(0-8), C(ss,av), and C(trough) 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.
authors.affiliation: Department of Cardiology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan. tsatoh@ks.kyorin-u.ac.jp
authors.forename: Toru
authors.initials: T
authors.lastname: Satoh
authors.forename: Tohru
authors.initials: T
authors.lastname: Satoh
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Saji
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Watanabe
authors.forename: Satoshi
authors.initials: S
authors.lastname: Ogawa
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Takehara
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Tanabe
authors.forename: Norikazu
authors.initials: N
authors.lastname: Yamada
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yao
authors.forename: Katsumasa
authors.initials: K
authors.lastname: Miyaji
authors.forename: Norifumi
authors.initials: N
authors.lastname: Nakanishi
authors.forename: Yumiko
authors.initials: Y
authors.lastname: Suzuki
authors.forename: Tadami
authors.initials: T
authors.lastname: Fujiwara
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kuriyama
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001794:Blood Pressure / Q000502:physiology; D005260:Female; D006801:Humans; D006976:Hypertension, Pulmonary / Q000188:drug therapy* / Q000208:ethnology* / Q000503:physiopathology; D007564:Japan; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010879:Piperazines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011687:Purines / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016896:Treatment Outcome; D014655:Vascular Resistance / Q000502:physiology; D014665:Vasodilator Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016138:Walking / Q000502:physiology; D055815:Young Adult
chemical_list: D010879:Piperazines; D011687:Purines; D013450:Sulfones; D014665:Vasodilator Agents; D020097:Natriuretic Peptide, Brain; D000068677:Sildenafil Citrate