Development of apixaban: a novel anticoagulant for prevention of stroke in patients with atrial fibrillation.
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).
Affiliation: Global Clinical Research, Research & Development, Bristol-Myers Squibb Company, Princeton, New Jersey.Show MeSH
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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).
Affiliation: Global Clinical Research, Research & Development, Bristol-Myers Squibb Company, Princeton, New Jersey.