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Development of apixaban: a novel anticoagulant for prevention of stroke in patients with atrial fibrillation.

Hanna MS, Mohan P, Knabb R, Gupta E, Frost C, Lawrence JH - Ann. N. Y. Acad. Sci. (2014)

Bottom Line: The factor Xa inhibitor apixaban is one of the novel anticoagulants to emerge as alternatives to long-standing standards of care that include low-molecular-weight heparin and warfarin.Twice-daily dosing of apixaban, rather than once daily, was chosen to lower peak concentrations and reduce fluctuations between peak and trough levels.In the AVERROES study of patients who were unsuitable for warfarin therapy, apixaban was superior to aspirin in reducing the risk of stroke or systemic embolism (SSE), without a significant increase in major bleeding (MB).

View Article: PubMed Central - PubMed

Affiliation: Global Clinical Research, Research & Development, Bristol-Myers Squibb Company, Princeton, New Jersey.

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Relative efficacy and safety of novel oral anticoagulants in AF. HRs and 95% CIs are shown for the primary efficacy end point of stroke or systemic embolism (solid symbols) and for ISTH major bleeding (open symbols) in the phase III warfarin-controlled registrational trials for apixaban, rivaroxaban, and dabigatran.29,38,39
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fig04: Relative efficacy and safety of novel oral anticoagulants in AF. HRs and 95% CIs are shown for the primary efficacy end point of stroke or systemic embolism (solid symbols) and for ISTH major bleeding (open symbols) in the phase III warfarin-controlled registrational trials for apixaban, rivaroxaban, and dabigatran.29,38,39

Mentions: For more than 50 years, warfarin and VKAs have been the only therapeutic options for chronic (oral) anticoagulation. In the past 5 years, a number of new agents have been developed, tested, and approved for this purpose. These development programs took place contemporaneously, were conducted in similar (although not always identical) populations, and used the same outcomes (e.g., SSE for efficacy, ISTH MB for safety). Although there were other differences in the trials (e.g., most, but not all, were double-blind; most used VKA as a comparator, AVERROES used aspirin), the similarities invite a brief comparison. Although one should avoid making cross-trial comparisons in the absence of head-to-head data, one might ask how the new agents compare with warfarin, the standard. Figure4 shows such a comparison, for stroke prevention in AF with the new agents compared to VKA.29,38,39 Each drug (or dose of a drug) is represented with the results for both efficacy and safety (HR and 95% CI).


Development of apixaban: a novel anticoagulant for prevention of stroke in patients with atrial fibrillation.

Hanna MS, Mohan P, Knabb R, Gupta E, Frost C, Lawrence JH - Ann. N. Y. Acad. Sci. (2014)

Relative efficacy and safety of novel oral anticoagulants in AF. HRs and 95% CIs are shown for the primary efficacy end point of stroke or systemic embolism (solid symbols) and for ISTH major bleeding (open symbols) in the phase III warfarin-controlled registrational trials for apixaban, rivaroxaban, and dabigatran.29,38,39
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4260137&req=5

fig04: Relative efficacy and safety of novel oral anticoagulants in AF. HRs and 95% CIs are shown for the primary efficacy end point of stroke or systemic embolism (solid symbols) and for ISTH major bleeding (open symbols) in the phase III warfarin-controlled registrational trials for apixaban, rivaroxaban, and dabigatran.29,38,39
Mentions: For more than 50 years, warfarin and VKAs have been the only therapeutic options for chronic (oral) anticoagulation. In the past 5 years, a number of new agents have been developed, tested, and approved for this purpose. These development programs took place contemporaneously, were conducted in similar (although not always identical) populations, and used the same outcomes (e.g., SSE for efficacy, ISTH MB for safety). Although there were other differences in the trials (e.g., most, but not all, were double-blind; most used VKA as a comparator, AVERROES used aspirin), the similarities invite a brief comparison. Although one should avoid making cross-trial comparisons in the absence of head-to-head data, one might ask how the new agents compare with warfarin, the standard. Figure4 shows such a comparison, for stroke prevention in AF with the new agents compared to VKA.29,38,39 Each drug (or dose of a drug) is represented with the results for both efficacy and safety (HR and 95% CI).

Bottom Line: The factor Xa inhibitor apixaban is one of the novel anticoagulants to emerge as alternatives to long-standing standards of care that include low-molecular-weight heparin and warfarin.Twice-daily dosing of apixaban, rather than once daily, was chosen to lower peak concentrations and reduce fluctuations between peak and trough levels.In the AVERROES study of patients who were unsuitable for warfarin therapy, apixaban was superior to aspirin in reducing the risk of stroke or systemic embolism (SSE), without a significant increase in major bleeding (MB).

View Article: PubMed Central - PubMed

Affiliation: Global Clinical Research, Research & Development, Bristol-Myers Squibb Company, Princeton, New Jersey.

Show MeSH
Related in: MedlinePlus