Key result
Peak rivaroxaban concentrations average ~2.7x higher in AF patients who develop hemorrhagic complications.
Why the study?
Does therapeutic drug monitoring of rivaroxaban identify patients at risk for hemorrhagic complications in atrial fibrillation?
Observational (n=65)
Does therapeutic drug monitoring of rivaroxaban identify patients at risk for hemorrhagic complications in atrial fibrillation?
Absolute Event Rate: 602.3% vs 224.9%
p-value: p=0.000002
Therapeutic drug monitoring of rivaroxaban may be advisable to prevent hemorrhagic complications, as standard dosing based on renal function can lead to critically high serum concentrations in some patients.
High rivaroxaban peaks were associated with bleeding in this AF cohort; leaves open whether TDM improves safety in prospective trials.
The results of a study of the concentration of rivaroxaban in the peripheral blood in patients with atrial fibrillation, receiving different doses of rivaroxaban, as well as in the case of developing hemorrhagic complications, are presented. 65 patients admitted for treatment for atrial fibrillation were examined. As an anticoagulant drug, rivaroxaban was prescribed at a dose of 15 or 20 mg once a day, depending on the state of renal function. The patients were divided into 3 groups depending on the prescribed dose of rivaroxaban and the presence or absence of hemorrhagic complications. At the same time, each patient underwent therapeutic drug monitoring of the drug. It was found that in patients, who received rivaroxaban at a dose of 15 mg, in 35% of cases its concentration in the blood was below the average minimum values. In patients, who received the drug at a dose of 20 mg, in 16% of cases its concentration in the blood serum exceeded the average maximum values. Patients treated with 15 mg of rivaroxaban lacked any hemorrhagic complications. In the group of patients with advanced hemorrhagic complications who received rivaroxaban at a dose of 20 mg, its serum concentration at all stages of therapeutic drug monitoring was significantly higher than the average maximum values and more than 4 times higher than in the control group (without hemorrhagic complications). The results of the study indicate the advisability of conducting therapeutic drug monitoring with the determination of rivaroxaban concentrations in the blood serum of patients receiving the drug, especially when they develop hemorrhagic complications.
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Kryukov et al. (2021) conducted an observational in Atrial fibrillation (n=65). Rivaroxaban vs. Patients without hemorrhagic complications was evaluated on Peak serum rivaroxaban concentration (ng/ml) at 3 hours post-dose (p=0.000002). Rivaroxaban peak serum concentrations were significantly higher in atrial fibrillation patients who developed hemorrhagic complications compared to those without complications (602.3 vs 224.9 ng/ml).
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