Document Detail

Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results.
MedLine Citation:
PMID:  22827490     Owner:  NLM     Status:  MEDLINE    
In this overview we address the three phase III studies that compared new oral anticoagulants (dabigatran, rivaroxaban and apixaban) with warfarin in the setting of stroke prevention in atrial fibrillation. Strengths and weaknesses of the studies were examined in detail through indirect comparison. We analyze and comment the inclusion and exclusion criteria, the characteristics of randomized patients, the primary efficacy and safety end points and side effects. All new oral anticoagulants resulted in being non-inferior to vitamin K antagonists in reducing stroke or systemic embolism in patients with atrial fibrillation. Dabigatran 150 mg and apixaban were superior to vitamin K antagonists. Importantly, new oral anticoagulants significantly reduced hemorrhagic stroke in all three studies. Major differences among new oral anticoagulants include the way they are eliminated and side effects. Both dabigatran and apixaban were tested in low- to moderate-risk patients (mean CHADS2 [Congestive heart failure, Hypertension, Age, Diabetes, Stroke] score = 2.1-2.2) whereas rivaroxaban was tested in high-risk patients (mean CHADS2 score = 3.48) and at variance with dabigatran and apixaban was administered once daily. Apixaban significantly reduced mortality from any cause. The choice of a new oral anticoagulant should take into account these and other differences between the new drugs.
V Pengo; L Crippa; A Falanga; G Finazzi; F Marongiu; M Moia; G Palareti; D Poli; S Testa; E Tiraferri; A Tosetto; A Tripodi; S Siragusa; C Manotti
Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Journal of thrombosis and haemostasis : JTH     Volume:  10     ISSN:  1538-7836     ISO Abbreviation:  J. Thromb. Haemost.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-02     Completed Date:  2013-02-28     Revised Date:  2013-08-27    
Medline Journal Info:
Nlm Unique ID:  101170508     Medline TA:  J Thromb Haemost     Country:  England    
Other Details:
Languages:  eng     Pagination:  1979-87     Citation Subset:  IM    
Copyright Information:
© 2012 International Society on Thrombosis and Haemostasis.
Department of Clinical Cardiology, Thrombosis Centre, University of Padua, Padua, Italy.
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MeSH Terms
Administration, Oral
Aged, 80 and over
Anticoagulants / administration & dosage*,  adverse effects,  pharmacokinetics
Atrial Fibrillation / blood,  complications,  drug therapy*
Benzimidazoles / administration & dosage
Clinical Trials, Phase III as Topic
Evidence-Based Medicine
Hemorrhage / chemically induced
Middle Aged
Morpholines / administration & dosage
Patient Safety
Preventive Health Services*
Pyrazoles / administration & dosage
Pyridones / administration & dosage
Randomized Controlled Trials as Topic
Stroke / blood,  etiology,  prevention & control*
Thiophenes / administration & dosage
Treatment Outcome
Warfarin / administration & dosage
beta-Alanine / administration & dosage,  analogs & derivatives
Reg. No./Substance:
0/Anticoagulants; 0/Benzimidazoles; 0/Morpholines; 0/Pyrazoles; 0/Pyridones; 0/Thiophenes; 0/rivaroxaban; 107-95-9/beta-Alanine; 3Z9Y7UWC1J/apixaban; 81-81-2/Warfarin; I0VM4M70GC/dabigatran
Comment In:
J Thromb Haemost. 2013 Jun;11(6):1203-5   [PMID:  23398659 ]
J Thromb Haemost. 2013 Jun;11(6):1205-6   [PMID:  23551993 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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