Influence of Gender and Coagulation Factors on Efficacy and Safety of Rivaroxaban in Adolescents & Young Adults with Venous Thromboembolism

2015 
Background: Venous thromboembolism [TE] is a multifactorial disease and antithrombotic therapy with Rivaroxaban [RIVA] is increasingly being administered for TE treatment in adults. Aim: The objective of the present study was to evaluate efficacy and safety of standard RIVA administered as routine medication in an outpatient cohort of patients with TE. Methods: In 212 consecutively admitted outpatients (14- i) as any TE or thrombus progression during treatment [TP], safety endpoints were defined as ii) significant bleeding [B] requiring any medical intervention, such as dose reduction, withdrawal of RIVA or death related to therapy. Descriptive analysis non-parametric statistics, Chi-square test and logistic regression were performed. Results: Patients were followed over a median of 12 months. The median daily RIVA dose of 0.25 mg (0.1-0.52) in females was significantly higher compared to males with 0.21 mg (0.09-0.4; p Conclusion: Along with good efficacy results our data demonstrate a high bleeding rate of 36.9% in women on standard RIVA. Lower RISTO activities in fertile/premenopausal women contributed significantly to B. Disclosures Kenet: Bayer, LFB, NovoNordisk: Membership on an entity9s Board of Directors or advisory committees. Nowak-Gottl: Bayer, LFB: Membership on an entity9s Board of Directors or advisory committees.
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