Key result
Routine NOAC plasma monitoring remains unnecessary for safe use despite utility in specific clinical scenarios.
Why the study?
Although NOACs are safely used at fixed doses without monitoring, measuring plasma levels can add information that may be useful in certain clinical scenarios.
In patients taking NOACs, does measuring plasma levels provide useful clinical information compared to fixed dosing without monitoring?
In patients taking NOACs, does measuring plasma levels provide useful clinical information compared to fixed dosing without monitoring?
While fixed-dose NOACs are generally safe and effective without monitoring, plasma level assessments may provide valuable information in certain clinical scenarios.
May inform select NOAC scenarios; leaves open prospective validation of actionable thresholds.
The class of new oral anticoagulants (NOACs) has been developed to provide reliable oral anticoagulation without the need for therapeutic drug monitoring. Based on phase I and II trials and pharmacokinetic and pharmacodynamic modeling, fixed drug doses have been selected for large phase III clinical trials for each currently available NOAC. In these trials, the use of the fixed dose without plasma level assessments was shown to be at least as effective and at least as safe as vitamin K antagonists with continuous therapeutic drug monitoring. Real world evidence reaffirms that the use of a fixed NOAC dose without plasma level assessment is safe and effective in a large variety of patients. Nevertheless, measurement of NOAC plasma levels can add information that may be useful in some clinical scenarios. This review discusses the possible use cases, the limitations, and the practical implementation of measuring NOAC plasma concentrations.
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Linden et al. (2022) conducted a review in Patients requiring oral anticoagulation. NOAC plasma level assessments was evaluated. Measurement of NOAC plasma levels can provide useful information in specific clinical scenarios, although routine therapeutic drug monitoring is not required for safe and effective fixed-dose NOAC use.
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