Why the study?
To analyze the frequency and variables related to inappropriate rivaroxaban dosage in clinical practice and its impact on outcomes after 2 years.
Does inappropriate dosing of rivaroxaban impact mortality and bleeding outcomes in patients with atrial fibrillation?
Does inappropriate dosing of rivaroxaban impact mortality and bleeding outcomes in patients with atrial fibrillation?
In real-world clinical practice in Spain, most atrial fibrillation patients receive appropriate rivaroxaban dosing, while inappropriate dosing shows trends toward worse mortality and bleeding outcomes.
Inappropriate rivaroxaban dosing trends toward worse outcomes but should not yet change practice; leaves open need for larger prospective studies in atrial fibrillation.
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.
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Sanmartı́n et al. (2021) studied this question.
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