Reply: Regarding the effect of dabigatran plasma concentrations

Journal of the American College of Cardiology

Volumn 63, Issue 25 PART A, 2014, Pages 2885-2886

  Reilly, Paul A ^a   Connolly, Stuart J ^b   Yusuf, Salim ^b   Eikelboom, John W ^b   Ezekowitz, Michael D ^b   Wallentin, Lars ^b  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; WARFARIN; DABIGATRAN ETEXILATE;

DRUG BLOOD LEVEL; DRUG EFFECT; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; KIDNEY DYSFUNCTION; LETTER; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; CEREBROVASCULAR ACCIDENT; DRUG APPROVAL; DRUG INFORMATION; DRUG MARKETING; HEART ATRIUM FIBRILLATION; HUMAN; INDIVIDUALIZATION; PATIENT MONITORING; POSTMARKETING SURVEILLANCE; TREATMENT OUTCOME; UNITED STATES;

ANTITHROMBINS; BENZIMIDAZOLES; FEMALE; HEMORRHAGE; HUMANS; MALE; PYRIDINES; STROKE;

EID: 84903188453     PISSN: 07351097     EISSN: 15583597     Source Type: Journal    
DOI: 10.1016/j.jacc.2014.04.012     Document Type: Letter

References (4)

1. P.A. Reilly, T. Lehr, S. Haertter on behalf of the RE-LY Investigators The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY trial (Randomized Evaluation of Long-Term Anticoagulation Therapy) J Am Coll Cardiol 63 2014 321 328
2. Advisory Committee briefing document for dabigatran Etexilate, section 4.6. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ UCM226009.pdf. Accessed April 2, 2014.
3. B.N. Beasley, E.F. Unger, and R. Temple Anticoagulant options - why the FDA approved a higher but not a lower dose of dabigatran N Engl J Med 364 2011 1788 1790
4. M.R. Southworth, M.E. Reichman, and E.F. Unger Dabigatran and postmarketing reports of bleeding N Engl J Med 368 2013 1272 1274