Bristol-Myers Squibb and Pfizer Present Large Real-World Observational Analysis of the Effectiveness and Safety of Direct Oral Anticoagulants…
In this observational analysis, medical and pharmacy claims were evaluated from the
"Studies such as this large
Eliquis, in this analysis, was associated with a significantly lower risk of stroke or systemic embolism (HR: 0.40, 95 percent CI: 0.31-0.53; p<0.0001) and lower rate of major bleeding (HR: 0.51, 95 percent CI: 0.44-0.58; p<0.0001) than patients treated with warfarin. The findings from the Eliquis-warfarin cohort complement the results of the randomized Phase 3 ARISTOTLE (Apixaban for Reduction In Stroke and Other ThromboemboLic Events in Atrial Fibrillation) trial.ivFor data on other cohorts, please refer to the full abstract (link is external).
"The
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Methodology
In addition to the apixaban cohort, this analysis of the
This analysis was designed according to the
Limitations of Real-World Data Analyses and of the
Real-world data have the potential to supplement randomized clinical trial data by providing additional information about how a medicine performs in routine medical practice. Real-world data analyses have several limitations. For example, the source and type of data used may limit the generalizability of the results and of the endpoints. It is important to note that there are no head-to-head clinical trials comparing direct oral anticoagulants.
In the
Due to these limitations, real-world data analyses cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment. Observational real-world studies can only evaluate association and not causality.ii,iii
About Eliquis
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved for multiple indications in the
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