Peak and Trough Concentration Ranges of Factor Xa Inhibitors for Preventing Thromboembolic Stroke in Korean Patients with Non-valvular Atrial Fibrillation
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Background: Current guidelines recommend factor IIa- or Xa-specific inhibitors over warfa- rin analogs for preventing thromboembolic stroke in patients with atrial fibrillation (AF). However, their plasma concentrations in Korean patients are not well understood. Methods: We conducted a single-center laboratory study to determine the distribution ranges of peak and trough concentrations of three factor Xa inhibitors (apixaban, edoxa- ban, and rivaroxaban) prescribed for preventing strokes in patients with AF. Patients receiv- ing one of these drugs and undergoing blood specimen collection for laboratory tests were screened. Blood specimens were obtained from patients who had adhered to the pre- scribed drug regimen consistently for at least 1 week. Drug plasma concentrations were measured using heparin liquid-reagent technology-based anti-Xa chromogenic assays. Results: We selected 459 patients who were taking standard or on-label-reduced doses of apixaban (N=252), edoxaban (N=182), or rivaroxaban (N=25). The 5th–95th percentile ranges of the peak concentrations were 84–414 ng/mL (apixaban), 72–424 ng/mL (edox- aban), and 97–517 ng/mL (rivaroxaban). The respective 5th–95th percentile ranges of the trough concentrations were 44–237 ng/mL, 23–93 ng/mL, and 13–219 ng/mL. Ap- proximately 19.6% (apixaban), 33.3% (edoxaban), and 64.0% (rivaroxaban) of patients in each group had peak concentrations out of the predicted distribution ranges based on pharmacokinetic data. Approximately 7.3%, 52.8%, and 8.3% of patients had trough con- centrations out of the predicted distribution ranges. Conclusions: A considerable proportion of Korean patients with AF taking factor Xa inhibi- tors may require population-specific reference ranges to guide therapeutic monitoring.
Abstract
Background: Current guidelines recommend factor IIa- or Xa-specific inhibitors over warfa- rin analogs for preventing thromboembolic stroke in patients with atrial fibrillation (AF). However, their plasma concentrations in Korean patients are not well understood. Methods: We conducted a single-center laboratory study to determine the distribution ranges of peak and trough concentrations of three factor Xa inhibitors (apixaban, edoxa- ban, and rivaroxaban) prescribed for preventing strokes in patients with AF. Patients receiv- ing one of these drugs and undergoing blood specimen collection for laboratory tests were screened. Blood specimens were obtained from patients who had adhered to the pre- scribed drug regimen consistently for at least 1 week. Drug plasma concentrations were measured using heparin liquid-reagent technology-based anti-Xa chromogenic assays. Results: We selected 459 patients who were taking standard or on-label-reduced doses of apixaban (N=252), edoxaban (N=182), or rivaroxaban (N=25). The 5th–95th percentile ranges of the peak concentrations were 84–414 ng/mL (apixaban), 72–424 ng/mL (edox- aban), and 97–517 ng/mL (rivaroxaban). The respective 5th–95th percentile ranges of the trough concentrations were 44–237 ng/mL, 23–93 ng/mL, and 13–219 ng/mL. Ap- proximately 19.6% (apixaban), 33.3% (edoxaban), and 64.0% (rivaroxaban) of patients in each group had peak concentrations out of the predicted distribution ranges based on pharmacokinetic data. Approximately 7.3%, 52.8%, and 8.3% of patients had trough con- centrations out of the predicted distribution ranges. Conclusions: A considerable proportion of Korean patients with AF taking factor Xa inhibi- tors may require population-specific reference ranges to guide therapeutic monitoring.