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Mutual pharmacokinetic interactions between steady-state bosentan and sildenafil
European journal of clinical pharmacology, 2008-01, Vol.64 (1), p.43-50
Burgess, Gary
Hoogkamer, Hans
Collings, Lorraine
Dingemanse, Jasper
2008
Details
Autor(en) / Beteiligte
Burgess, Gary
Hoogkamer, Hans
Collings, Lorraine
Dingemanse, Jasper
Titel
Mutual pharmacokinetic interactions between steady-state bosentan and sildenafil
Ist Teil von
European journal of clinical pharmacology, 2008-01, Vol.64 (1), p.43-50
Ort / Verlag
Berlin/Heidelberg: Springer-Verlag
Erscheinungsjahr
2008
Link zum Volltext
Quelle
MEDLINE
Beschreibungen/Notizen
Objective The aim of this study was to systematically investigate the mutual pharmacokinetic interactions in healthy volunteers between sildenafil, a phosphodiesterase-5 inhibitor, and bosentan, a dual endothelin receptor antagonist, both approved for treating pulmonary arterial hypertension (PAH). Methods A randomised, double-blind, placebo-controlled, parallel-group study with three treatment arms (sildenafil plus placebo, bosentan plus placebo and sildenafil plus bosentan) was conducted in 55 healthy male volunteers (51 completers). Study duration was 18 days per treatment group. Sildenafil was administered three times daily on Days 1–6 and 11–16 (20 mg initially, increased to 80 mg after 3 days), and bosentan (125 mg) was administered twice daily on Days 7–17. Results On Day 16, bosentan decreased the maximum plasma concentration of sildenafil © max ) by 55.4% [90% confidence interval (CI) 40.3–66.6%] and the area under the plasma concentration versus time curve over a dosing interval by 62.6% (90% CI 56.8–67.7%). Sildenafil increased bosentan C max by 42.0% (90% CI 15.4–74.8%) and by 49.8% (90% CI 28.7–74.5%). Bosentan and sildenafil in combination were well tolerated, with no serious adverse events reported. All adverse events were of mild or moderate intensity. Conclusions In healthy volunteers, there is a mutual pharmacokinetic interaction between bosentan and sildenafil that may influence the dosage of each drug in a combination treatment. The clinical implications of combination therapy with bosentan and sildenafil are as yet unknown, and further trials in patients with PAH are needed.
Sprache
Englisch
Identifikatoren
ISSN: 0031-6970
eISSN: 1432-1041
DOI: 10.1007/s00228-007-0408-z
Titel-ID: cdi_proquest_journals_2694727494
Format
–
Schlagworte
Adolescent
,
Adult
,
Adverse events
,
Antagonist drugs
,
Antihypertensive Agents - adverse effects
,
Antihypertensive Agents - pharmacokinetics
,
Antihypertensive Agents - pharmacology
,
Area Under Curve
,
Biological and medical sciences
,
Biomedical and Life Sciences
,
Biomedicine
,
Clinical outcomes
,
Clinical trials
,
Double-Blind Method
,
Drug Interactions
,
Drug Therapy, Combination
,
Endothelin
,
Humans
,
Hypertension
,
Hypertension, Pulmonary - drug therapy
,
Inhibitor drugs
,
Male
,
Medical sciences
,
Pharmacokinetics
,
Pharmacokinetics and Disposition
,
Pharmacology
,
Pharmacology. Drug treatments
,
Pharmacology/Toxicology
,
Phosphodiesterase
,
Phosphodiesterase Inhibitors - adverse effects
,
Phosphodiesterase Inhibitors - pharmacokinetics
,
Phosphodiesterase Inhibitors - pharmacology
,
Piperazines - adverse effects
,
Piperazines - pharmacokinetics
,
Piperazines - pharmacology
,
Placebos
,
Pulmonary Artery
,
Purines - adverse effects
,
Purines - pharmacokinetics
,
Purines - pharmacology
,
Side effects
,
Sildenafil
,
Sildenafil Citrate
,
Sulfonamides - adverse effects
,
Sulfonamides - pharmacokinetics
,
Sulfonamides - pharmacology
,
Sulfones - adverse effects
,
Sulfones - pharmacokinetics
,
Sulfones - pharmacology
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