Dosing regimens of apixaban used in routine clinical practice in France for nonvalvular AF patients–results from the PAROS study - 05/01/18
Résumé |
Introduction |
Apixaban is an anticoagulant approved for the prevention of stroke and systemic embolism in nonvalvular atrial fibrillation (NVAF) patients. A registry providing real-world data on the conditions of use of apixaban in France, in particular the dosing regimen, was required by regulatory authorities.
Purpose |
To describe the real-world dosing regimen of apixaban prescribed for NVAF patients in France.
Methods |
This was an observational, nationwide, cross-sectional study conducted among 177 French cardiologists who included 1059 NVAF patients initiating apixaban in the 3 months prior to the study visit.
Results |
Observed daily doses of apixaban were 5mg BID (full dose) for 69.5% of the patients and 2.5mg BID (adjusted dose) for 30.5% of the patients. Among patients treated with a full dose, 99.7% had a creatinine clearance (CrCl) ≥30mL/min, 83.6% were aged ≤80 years and 85.0% had a weight ≥60kg. Among patients treated with an adjusted dose, 93.2% had a CrCl ≥30mL/min, 27.2% were aged ≤80 years and 65.1% had a weight ≥60kg. Overall, 79.3% received a dose consistent with SmPC criteria: 98.1% of patients treated with a full dose were consistent with the SmPC and 36.3% of patients receiving adjusted dose had characteristics consistent with SmPC (≥2 of: age ≥80 years, weight ≤60kg, serum creatinine ≥1.5mg/dL; Or CrCl <30mL/min). Among inconsistent patients treated with an adjusted dose, 24.1% were also receiving antiplatelet therapy and 58.1% had only age ≥80 years as a criteria.
Conclusions |
An adjusted dose of apixaban was used in a third of the treated population and was mainly associated with old age. Overall, nearly 80% received a dose compliant with SmPC criteria. These results indicate a well-adopted dose adjustment of Apixaban in clinical practice.
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Vol 10 - N° 1
P. 88 - janvier 2018 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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