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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| Published in | Journal of the American College of Cardiology Vol. 58; no. 5; p. 551 |
|---|---|
| Main Author | |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
26.07.2011
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0735-1097 1558-3597 1558-3597 |
| DOI | 10.1016/j.jacc.2011.04.016 |
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| Abstract | 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). |
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| AbstractList | 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). |
| Author | Gage, Lawrence |
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| Cites_doi | 10.1056/NEJMoa0905561 10.1016/j.jacc.2011.01.010 |
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| Copyright | 2011 American College of Cardiology Foundation American College of Cardiology Foundation Copyright Elsevier Limited Jul 26, 2011 |
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| References | Wann, Curtis, Ellenbogen (bib1) 2011; 57 bib3 Connolly, Ezekowitz, Yusuf (bib2) 2009; 361 Wann (10.1016/j.jacc.2011.04.016_bib1) 2011; 57 Connolly (10.1016/j.jacc.2011.04.016_bib2) 2009; 361 21324629 - J Am Coll Cardiol. 2011 Mar 15;57(11):1330-7 |
| References_xml | – ident: bib3 article-title: Center for Drug Evaluation and Research, Application number 22-512, Summary Review, Deputy Office Director Decisional Memo, October 19, 2010: page 15 – volume: 361 start-page: 1139 year: 2009 end-page: 1151 ident: bib2 article-title: Dabigatran versus warfarin in patients with atrial fibrillation publication-title: N Engl J Med – volume: 57 start-page: 1330 year: 2011 end-page: 1337 ident: bib1 article-title: 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines publication-title: J Am Coll Cardiol – volume: 361 start-page: 1139 year: 2009 ident: 10.1016/j.jacc.2011.04.016_bib2 article-title: Dabigatran versus warfarin in patients with atrial fibrillation publication-title: N Engl J Med doi: 10.1056/NEJMoa0905561 – volume: 57 start-page: 1330 year: 2011 ident: 10.1016/j.jacc.2011.04.016_bib1 article-title: 2011 ACCF/AHA/HRS focused update on the management of patients with atrial fibrillation (update on dabigatran): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines publication-title: J Am Coll Cardiol doi: 10.1016/j.jacc.2011.01.010 – reference: 21324629 - J Am Coll Cardiol. 2011 Mar 15;57(11):1330-7 |
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| SubjectTerms | 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 |
| Title | Dabigatran in Patients With Nonvalvular Atrial Fibrillation |
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