Thromboembolic and bleeding events with rivaroxaban in clinical practice in Spain: impact of inappropriate doses (the EMIR study)
Por:
Fernandez, MS, Marin, F, Rafols, C, Arribas, F, Barrios, V, Cosin-Sales, J, Sanchez, MA, Vilades, D, LEKUONA, IÑAKI
Publicada:
1 abr 2021
Ahead of Print:
1 mar 2021
Resumen:
Aim: To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years. Materials & methods: Postauthorization, observational, multicenter study, in which atrial fibrillation patients, treated with rivaroxaban >= 6 months were included. Results: A total of 1421 patients (74.2 +/- 9.7 years, CHA(2)DS(2)-VASc 3.5 +/- 1.6) were included. Overall, 22.9% received rivaroxaban 15 mg. The proper dose of rivaroxaban was taken by 83.3% (9.7% underdosed, 7.0% overdosed). Older age and renal insufficiency were associated with inadequate rivaroxaban dosage. There was a trend toward higher all-cause mortality among underdosed patients (adjusted hazard ratio 1.39; 95% CI 0.75-2.58), and more bleedings in overdosed patients (2.29 vs 0.80 events/100 patient-years; p = 0.14). Conclusion: In clinical practice, rivaroxaban is properly dosed in most patients.
Filiaciones:
Fernandez, MS:
Hosp Ramon & Cajal, Dept Cardiol, Madrid, Spain
Marin, F:
Univ Murcia, Hosp Clin Univ Virgen de la Arrixaca, IMIB Arrixaca, Dept Cardiol,CIBERCV, Murcia, Spain
Rafols, C:
Bayer Hispania, Dept Med Affairs, Barcelona, Spain
Arribas, F:
Hosp Univ 12 Octubre, Dept Cardiol, Madrid, Spain
Univ Complutense Madrid UCM, Fac Med, Dept Med, Madrid, Spain
CIBERCV, Inst Invest Sanitaria Hosp 12 Octubre Imas12, Madrid, Spain
Barrios, V:
Hosp Ramon & Cajal, Dept Cardiol, Madrid, Spain
Alcala Univ, Madrid, Spain
Cosin-Sales, J:
Hosp Arnau Vilanova, Dept Cardiol, Valencia, Spain
Sanchez, MA:
Univ Cordoba, IMIBIC, Hosp Univ Reina Sofia, Dept Cardiol, Cordoba, Spain
Vilades, D:
Institut d’Investigació Biomèdica Sant Pau (IIB SANT PAU), Sant Quintí 77-79, 08041 Barcelona, Spain
LEKUONA, IÑAKI:
Hospital de Galdakao, Galdakao, Spain
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