Document Detail


Safety, tolerability and pharmacokinetics of an intravenous bolus of sildenafil in patients with pulmonary arterial hypertension.
MedLine Citation:
PMID:  21219411     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIMS: To assess pharmacokinetics and pharmacodynamics of a 10 mg intravenous sildenafil bolus in pulmonary arterial hypertension (PAH) patients stabilized on 20 mg sildenafil orally three times daily.
METHODS: Pharmacokinetic parameters were calculated using noncompartmental analysis.
RESULTS: After an acute increase, plasma concentrations stabilized within the range reported previously for a 20 mg oral tablet. At 0.5 h, mean ± SD changes from baseline were -8.4 ± 11.7 mmHg (systolic pressure), -2.6 ± 7.3 mmHg (diastolic pressure) and -3.5 ± 10.4 beats min(-1) (heart rate). There was no symptomatic hypotension.
CONCLUSIONS: Although further research is warranted, a 10 mg sildenafil intravenous bolus appears to provide similar exposure, tolerability and safety to the 20 mg tablet.
Authors:
Jean-Luc Vachiery; Sandrine Huez; Hunter Gillies; Gary Layton; Naoto Hayashi; Xiang Gao; Robert Naeije
Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  British journal of clinical pharmacology     Volume:  71     ISSN:  1365-2125     ISO Abbreviation:  Br J Clin Pharmacol     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-01-11     Completed Date:  2011-03-29     Revised Date:  2012-02-01    
Medline Journal Info:
Nlm Unique ID:  7503323     Medline TA:  Br J Clin Pharmacol     Country:  England    
Other Details:
Languages:  eng     Pagination:  289-92     Citation Subset:  IM    
Copyright Information:
© 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.
Affiliation:
Pulmonary Hypertension and Heart Failure Clinic, Hôpital Erasme, Brussels, Belgium. jvachier@ulb.ac.be
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00800592
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adolescent
Adult
Aged
Antihypertensive Agents / administration & dosage*,  adverse effects,  blood
Drug Administration Schedule
Female
Humans
Hypertension, Pulmonary / blood,  drug therapy*
Infusions, Intravenous
Male
Middle Aged
Phosphodiesterase 5 Inhibitors / administration & dosage,  adverse effects,  blood
Piperazines / administration & dosage*,  adverse effects,  blood
Purines / administration & dosage,  adverse effects,  blood
Sulfones / administration & dosage*,  adverse effects,  blood
Vasodilator Agents / administration & dosage*,  adverse effects,  blood
Young Adult
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Phosphodiesterase 5 Inhibitors; 0/Piperazines; 0/Purines; 0/Sulfones; 0/Vasodilator Agents; 139755-83-2/sildenafil

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