Document Detail


A phase III, multicenter, collaborative, open-label clinical trial of sildenafil in Japanese patients with pulmonary arterial hypertension.
MedLine Citation:
PMID:  21304214     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 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:
Toru Satoh; 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
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study     Date:  2011-02-04
Journal Detail:
Title:  Circulation journal : official journal of the Japanese Circulation Society     Volume:  75     ISSN:  1347-4820     ISO Abbreviation:  Circ. J.     Publication Date:  2011  
Date Detail:
Created Date:  2011-03-01     Completed Date:  2011-07-07     Revised Date:  2012-01-09    
Medline Journal Info:
Nlm Unique ID:  101137683     Medline TA:  Circ J     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  677-82     Citation Subset:  IM    
Affiliation:
Department of Cardiology, Kyorin University School of Medicine, 6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan. tsatoh@ks.kyorin-u.ac.jp
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Aged, 80 and over
Blood Pressure / physiology
Female
Humans
Hypertension, Pulmonary / drug therapy*,  ethnology*,  physiopathology
Japan
Male
Middle Aged
Natriuretic Peptide, Brain / blood
Piperazines / adverse effects,  pharmacokinetics,  therapeutic use*
Purines / adverse effects,  pharmacokinetics,  therapeutic use
Sulfones / adverse effects,  pharmacokinetics,  therapeutic use*
Treatment Outcome
Vascular Resistance / physiology
Vasodilator Agents / adverse effects,  pharmacokinetics,  therapeutic use*
Walking / physiology
Young Adult
Chemical
Reg. No./Substance:
0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 114471-18-0/Natriuretic Peptide, Brain; 139755-83-2/sildenafil
Comments/Corrections
Erratum In:
Circ J. 2011 Jul;75(7):1779
Note: Satoh, Tohru [corrected to Satoh, Toru]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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