Is There A Role For Pharmacokinetic/Pharmacodynamic Guided Dosing For Novel Oral Anticoagulants?

Publication date: Available online 10 October 2017 Source:American Heart Journal Author(s): Noel Chan, Philip T. Sager, Jack Lawrence, Thomas's Ortel, Paul Reilly, Scott Berkowitz, Dagmar Kubitza, John Eikelboom, Jeffry Florian, Norman Stockbridge, Martin Rose, Robert Temple, Jonathan H. Seltzer The novel direct oral anticoagulants (NOACs) represent a major advance in oral anticoagulant therapy, and are replacing vitamin K antagonists as the preferred options for many indications. Given in fixed doses without routine laboratory monitoring, they have been shown to be at least as effective in reducing thromboembolic stroke as dose-adjusted warfarin in phase 3 randomized trials and less likely to cause hemorrhagic stroke. Pharmacokinetic and/or pharmacodynamic sub-analyses of the major NOAC trials in patients with atrial fibrillation (AF) have established relationships between clinical characteristics, and drug levels and/or pharmacodynamic responses with both efficacy and safety. Based on these analyses, pharmaceutical manufacturers and regulatory authorities have provided contraindications and dosing recommendations based on clinical characteristics that are associated with drug levels and/or pharmacodynamic responses, stroke reduction, and bleeding risk to optimize the risk–benefit profile of the NOACs in the real world. The current fixed dosing strategy of NOACs have triggered discussions about the potential value of laboratory monitoring and dose adjustment...

Source: American Heart Journal - October 10, 2017 Category: Cardiology Source Type: research