Key result
Once-daily dosing of rivaroxaban is clinically appropriate for most indications, though empirical validation is required as a single dosing frequency does not fit all clinical scenarios.
Why the study?
What is the evidence and rationale for once-daily dosing regimens of rivaroxaban across its various clinical indications?
What is the evidence and rationale for once-daily dosing regimens of rivaroxaban across its various clinical indications?
This review summarizes the clinical development program of rivaroxaban, concluding that while once-daily dosing is appropriate for most indications, specific dosing regimens must be empirically validated for each clinical scenario.
Answers are grounded in this paper and cite their sources.
Early-phase rivaroxaban data in a new population support further dosing evaluation; leaves open phase 3 efficacy and safety confirmation.
BACKGROUND: Rivaroxaban, a direct factor Xa inhibitor, has been developed to meet clinical needs in a broad range of indications in adults: prevention of venous thromboembolism after elective hip or knee replacement surgery, treatment and secondary prevention of venous thromboembolism, prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation having one or more risk factors, and in Europe, prevention of atherothrombotic events after an acute coronary syndrome in patients with elevated cardiac biomarkers. However, the precise dose and regimen vary with the indication, leading to this effort to provide clarity concerning the appropriate use of rivaroxaban. This article reviews the clinical development program for rivaroxaban and summarizes the evidence for each approved, indication-specific dose regimen. RESULTS: Although initially investigated for twice-daily dosing, early observations, including the finding that the pharmacodynamic effects of rivaroxaban last longer than the elimination half-life, suggested that once-daily dosing might be attainable and effective. These observations were evaluated within the extensive phase II program, which, together with pharmacology studies, provides the evidence underpinning the selection of once-daily regimens for most, but not all, of the approved clinical indications for rivaroxaban. CONCLUSION: The evidence for each dosing regimen demonstrates that although pharmacology studies are of paramount importance, dose regimens must be subjected to careful empirical validation. Once-daily dosing was shown to be clinically appropriate for most rivaroxaban indications. Furthermore, a "one size fits all" approach to dosing frequency is unlikely to result in a regimen that yields optimal patient outcomes across different indications.
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Kubitza et al. (2016) conducted a review in Multiple indications (venous thromboembolism, atrial fibrillation, acute coronary syndrome). Rivaroxaban was evaluated. Once-daily dosing of rivaroxaban is clinically appropriate for most indications, though empirical validation is required as a single dosing frequency does not fit all clinical scenarios.
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