Dabigatran in Patients With Nonvalvular Atrial Fibrillation

The U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products explains, but hardly reassures: "Based on pharmacokinetic modeling, comparing pharmacokinetic data from RE-LY with data from a small study of subjects with compromised renal function, a dosing regimen of 7...

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Bibliographic Details
Published in	Journal of the American College of Cardiology Vol. 58; no. 5; p. 551
Main Author	Gage, Lawrence
Format	Journal Article
Language	English
Published	United States Elsevier Inc 26.07.2011 Elsevier Limited
Subjects	Anticoagulants - administration & dosage Anticoagulants - adverse effects Anticoagulants - pharmacokinetics Atrial Fibrillation - drug therapy Benzimidazoles - administration & dosage Benzimidazoles - adverse effects Benzimidazoles - pharmacokinetics beta-Alanine - administration & dosage beta-Alanine - adverse effects beta-Alanine - analogs & derivatives beta-Alanine - pharmacokinetics Cardiac arrhythmia Cardiology Cardiovascular Creatinine - blood Creatinine - urine Dabigatran Dose-Response Relationship, Drug Hemorrhage - chemically induced Humans Internal Medicine Medical treatment Patients Practice Guidelines as Topic
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ISSN	0735-1097 1558-3597 1558-3597
DOI	10.1016/j.jacc.2011.04.016

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Summary:	The U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products explains, but hardly reassures: "Based on pharmacokinetic modeling, comparing pharmacokinetic data from RE-LY with data from a small study of subjects with compromised renal function, a dosing regimen of 75 mg bid appears appropriate for patients with estimated CrCL 15 to 30 mL/min" (3).
Bibliography:	SourceType-Scholarly Journals-1 ObjectType-Correspondence-1 content type line 14 ObjectType-Correspondence-2 content type line 23 ObjectType-Commentary-1
ISSN:	0735-1097 1558-3597 1558-3597
DOI:	10.1016/j.jacc.2011.04.016