Body Weight Has Limited Influence on the Safety, Tolerability, Pharmacokinetics, or Pharmacodynamics of Rivaroxaban (BAY 59-7939) in Healthy Subjects

Anticoagulants are often dose adjusted, or their use restricted, in patients with extremes of body weight. Rivaroxaban (BAY 59‐7939) is a novel, oral, direct factor Xa inhibitor in clinical development. This was a randomized, single‐blind, placebo‐controlled, parallel‐group study in healthy male and...

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Veröffentlicht in:Journal of clinical pharmacology Jg. 47; H. 2; S. 218 - 226
Hauptverfasser: Kubitza, Dagmar, Becka, Michael, Zuehlsdorf, Michael, Mueck, Wolfgang
Format: Journal Article
Sprache:Englisch
Veröffentlicht: Oxford, UK Blackwell Publishing Ltd 01.02.2007
SAGE Publications
Sage Publications, Inc
Schlagworte:
Adult
Anticoagulants (Medicine)
Anticoagulants - adverse effects
Anticoagulants - pharmacokinetics
Anticoagulants - pharmacology
Antithrombin III - adverse effects
Antithrombin III - pharmacokinetics
Antithrombin III - pharmacology
BAY 59-7939
Body Weight
Drug therapy
Factor Xa inhibitors
Female
gender
Humans
Male
Middle Aged
Morpholines - adverse effects
Morpholines - pharmacokinetics
Morpholines - pharmacology
Partial Thromboplastin Time
Physiological aspects
Prothrombin Time
Rivaroxaban
Thiophenes - adverse effects
Thiophenes - pharmacokinetics
Thiophenes - pharmacology
Thromboembolism
United States
ISSN:0091-2700, 1552-4604
Online-Zugang:Volltext
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Zusammenfassung:Anticoagulants are often dose adjusted, or their use restricted, in patients with extremes of body weight. Rivaroxaban (BAY 59‐7939) is a novel, oral, direct factor Xa inhibitor in clinical development. This was a randomized, single‐blind, placebo‐controlled, parallel‐group study in healthy male and female subjects to assess the effect of extreme body weight (≤50 kg and >120 kg), and gender, on the safety, tolerability, pharmacokinetics, and pharmacodynamics of rivaroxaban 10 mg, compared with subjects of normal weight (70–80 kg). Rivaroxaban was well tolerated. Cmax of rivaroxaban was unaffected in subjects >120 kg but was increased by 24% in subjects weighing ≤5 0 kg, resulting in a small (15%) increase in prolongation of prothrombin time, which was not considered clinically relevant. The area under the curve was unaffected by body weight or gender. No other clinically relevant differences were observed, suggesting that rivaroxaban is unlikely to require dose adjustment for body weight or gender.
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ArticleID:JCPH1237
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SourceType-Scholarly Journals-1
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content type line 23
ObjectType-Undefined-3
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270006296058