Assessment of low plasma concentrations of apixaban in the periprocedural setting

Lessire, Sarah; Dincq, Anne-Sophie; Siriez, Romain; Pochet, Lionel; Sennesael, Anne-Laure; Vornicu, Ovidiu Ionut; Hardy, Michaël; Deceuninck, Olivier; Douxfils, Jonathan; Mullier, François

doi:10.1111/ijlh.13202

Cited by 6 publications

(3 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, it must be emphasized this anti‐FXa measuring method cannot differentiate between anti‐FXa drugs, and there will generally be additive effects with more than one anti‐FXa drug exposure (e.g. LMWH + direct FXa inhibitor) 75,76 …”

Section: Doac Testing Myth 2—methods For Rapid Doac Testing Are Too E...mentioning

confidence: 99%

“…75,76 These do not reflect test result turnaround times, only test time on automated analyzer, with manual testing likely associated with increased time to test reporting. Average time based on presumption reagents are on board instruments and ready for use, the number of testing steps, test incubation periods, and maximum clotting times using automated platforms with eventual result generation and transmittance to electronic laboratory information system or medical record.…”

mentioning

confidence: 99%

See 1 more Smart Citation

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

Gosselin

Favaloro

Douxfils

2022

Journal of Thrombosis and Haemostasis

Self Cite

View full text Add to dashboard Cite

For more than a decade, US laboratories have failed to implement solutions to help their clinicians in managing complex situations or patients on direct oral anticoagulants (DOACs). The problem may find different origins, among which is the position of the Food and Drug Administration, which categorized these drugs as monitoring‐ and measurement‐free, whereas other regulatory bodies like the European Medicines Agency or the Therapeutic Goods Administration in Australia were more conservative on the principle that the absence of proof (of monitoring/measurement benefits) is not proof of an absence (of monitoring/measurement needs). Pivotal clinical studies that led to the approval of DOACs were presented as devoid of such testing, although some companies considered monitoring as a solution to improve their benefit/risk ratio. In this JTH In Clinics issue, we report more than a decade of development that has permitted the activation of smart laboratory solutions to qualify or quantify DOACs and discuss myths and misconceptions around technical and regulatory requirements that support the current reluctance of implementing these technologies in most US laboratories. Use of DOACs is ever expanding, with DOAC prescriptions now exceeding those of other anticoagulants, including vitamin K antagonists, in some geographies. As this use increases, the likely need to measure DOAC exposure will also increase. Measurement of DOACs does not represent any technical difficulty. That these laboratory tests are not available in some locations suggests disparities in patient care, and we suggest it is time to address such inequalities.

show abstract

Section: Doac Testing Myth 2—methods For Rapid Doac Testing Are Too E...mentioning

confidence: 99%

mentioning

confidence: 99%

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

Gosselin

Favaloro

Douxfils

2022

Journal of Thrombosis and Haemostasis

Self Cite

View full text Add to dashboard Cite

show abstract

“…However, real-world data on the effect of renal function and plasma apixaban level as well as its association with bleeding complications are lacking. The plasma level of apixaban can be measured via chromogenic anti-Xa assessment using commercially available assays with reasonable accuracy and precision even at low plasma concentrations ( Lessire et al, 2020 ). It is also recognized that substantial differences exist in thromboembolic events and bleeding risks according to ethnicity.…”

Section: Introductionmentioning

confidence: 99%

Plasma apixaban levels in Chinese patients with chronic kidney disease—Relationship with renal function and bleeding complications

Sin

Wong

et al. 2022

Front. Pharmacol.

View full text Add to dashboard Cite

Introduction: Accumulation of apixaban in plasma is a major concern in patients with chronic kidney disease (CKD). Studies that investigated plasma apixaban level in CKD patients and its association with clinically significant events are scarce.Methods: Patients with CKD Stage 1–4 who were taking apixaban, either 2.5 mg BD or 5 mg BD were recruited. The peak and trough plasma apixaban level were measured after 2 h and 12 h of last dose respectively. The results were correlated with renal function and clinical events during the period of follow-up from 1 January 2018 to 31 October 2021.Results: 141 patients (CKD Stage 1, n = 12; Stage 2, n = 74; Stage 3, n = 48, stage 4, n = 7) were included for analysis. The plasma peak and trough apixaban were significantly higher in patients with CKD stage 3 when compared with those having CKD stage 2 and 1 (peak levels: 223.4 ± 107.8 ng/ml vs. 161.0 ± 55.2 ng/ml vs. 126.6 ± 30.2 ng/ml; trough levels: 118.3 ± 67.9 ng/ml vs. 81.2 ± 33.0 ng/ml vs. 51.9 ± 31.1 ng/ml, p < 0.05 or all) in patients taking 5 mg BD. Plasma trough apixaban level was negatively correlated with eGFR in patients taking 5 mg BD (r2 = −0.174, p < 0.001) and 2.5 mg BD (r2 = −0.215, p < 0.05). The plasma peak and trough apixaban level correlated with PT (r2 = 0.065, p = 0.003 and r2 = 0.096, p < 0.01 respectively). Multivariate analysis showed that plasma trough apixaban levels were associated with the risk of bleeding complications (Odd ratio: 1.011, 95% CI:1.002–1.021, p = 0.023).Conclusion: The plasma apixaban level shows a trend of increase with worsening renal function, and an increase in the plasma apixaban level is suggestive of an increased risk of bleeding complications in patients with CKD. Further large-scale prospective studies are needed to evaluate relationship between plasma apixaban level and renal function as well as safety outcome in CKD patients. Moreover, the role of drug level monitoring should be prospectively evaluated for dosage optimization and the minimization of bleeding risks in CKD patients.

show abstract

Inappropriate low dosing of direct oral anticoagulants in older patients with non-valvular atrial fibrillation: Impact on plasma drug levels

Comans

Sennesael²,

Bihin

et al. 2021

Thrombosis Research

View full text Add to dashboard Cite

Assessment of low plasma concentrations of apixaban in the periprocedural setting

Cited by 6 publications

References 24 publications

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

The myths behind DOAC measurement: Analyses of prescribing information from different regulatory bodies and a call for harmonization

Plasma apixaban levels in Chinese patients with chronic kidney disease—Relationship with renal function and bleeding complications

Inappropriate low dosing of direct oral anticoagulants in older patients with non-valvular atrial fibrillation: Impact on plasma drug levels

Contact Info

Product

Resources

About