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 150mg 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.

Pengo, V., Crippa, L., Falanga, A., Finazzi, G., Marongiu, F., Moia, M., et al. (2012). Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results. JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 10(10), 1979-1987 [10.1111/j.1538-7836.2012.04866.x].

Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results

Falanga A;
2012

Abstract

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 150mg 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.
Articolo in rivista - Articolo scientifico
novel oral anticoagulants, atrial fibrillation
English
2012
10
10
1979
1987
reserved
Pengo, V., Crippa, L., Falanga, A., Finazzi, G., Marongiu, F., Moia, M., et al. (2012). Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation: a look beyond the excellent results. JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 10(10), 1979-1987 [10.1111/j.1538-7836.2012.04866.x].
File in questo prodotto:
File Dimensione Formato  
PENGO_et_al-2012-Journal_of_Thrombosis_and_Haemostasis.pdf

Solo gestori archivio

Dimensione 122.31 kB
Formato Adobe PDF
122.31 kB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/280973
Citazioni
  • Scopus 29
  • ???jsp.display-item.citation.isi??? 30
Social impact