Why the study?
Patients with obesity or advanced renal impairment represented a small portion of patients in phase 3 DOAC trials for venous thromboembolism, leaving limited randomized data to guide drug and dose selection in these populations.
Are direct oral anticoagulants safe and effective for the treatment of venous thromboembolism in patients with advanced renal impairment or obesity?
Are direct oral anticoagulants safe and effective for the treatment of venous thromboembolism in patients with advanced renal impairment or obesity?
This review provides comprehensive guidance on the pharmacokinetics, pharmacodynamics, and clinical data for DOAC use and dosing in VTE patients with obesity or advanced renal impairment.
DOAC use in obesity or advanced renal impairment requires PK-guided caution; leaves open dedicated outcome trials.
There are currently more than 7 million patients taking a direct oral anticoagulant (DOAC), with more new prescriptions per year than warfarin. Despite impressive efficacy and safety data for the treatment of venous thromboembolism, patients with obesity or advanced renal impairment represented a small portion of the patients enrolled in the phase 3 clinical trials. Therefore, to evaluate the potential use of DOACs in these special populations, clinicians need to have an understanding of the pharmacokinetics and pharmacodynamics of these agents in these settings. Since data from randomized controlled trials are limited, data from observational trials are helpful in gaining comfort with the use of DOACs in these special populations. Selecting the appropriate dose for each agent is imperative in achieving optimal patient outcomes. We provide an extensive review of the pharmacokinetics, pharmacodynamics, phase 3 clinical trials, and observational studies on the use of DOACs in patients with advanced renal impairment, obesity, or other weight-related special populations to provide clinicians with a comprehensive understanding of the data for optimal drug and dose selection.
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Dobesh et al. (2021) studied this question.
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