Abstract
Edoxaban is a direct factor Xa inhibitors approved for stroke prevention in atrial fibrillation (SPAF) and for venous thromboembolism (VTE) treatment. Edoxaban is given in a fixed dosing regimen (with recommended dose reductions for patients with renal impairment or body weight < 60 kg or concomitant treatment with P-gp inhibitors). Of note, despite a large volume of distribution, edoxaban dose adjustments for overweight patients are not recommended, although increasing body mass may theoretically result in a relative underdosing. Early Pharmacokinetic/Pharmacodynamic (PK/PD) studies have indicated that the effect of body mass index (BMI) on edoxaban exposure is small but measurable [ [1] Yin O.Q. Tetsuya K. Miller R. Edoxaban population pharmacokinetics and exposure-response analysis in patients with non-valvular atrial fibrillation. Eur. J. Clin. Pharmacol. 2014; 70 (Nov): 1339-1351 Crossref PubMed Scopus (58) Google Scholar ]. The recently updated guidance of the Standardization Subcommittee (SSC) of the International Society of Thrombosis and Haemostasis (ISTH) concludes that rivaroxaban or apixaban are among appropriate anticoagulant options regardless of high BMI and weight but recommended not to use dabigatran, edoxaban, or betrixaban in patients with BMI > 40 kg/m2 or weight > 120 kg, given unconvincing data for dabigatran, and lack of clinical or PK/PD data for edoxaban and betrixaban [ [2] Martin K.A. Beyer-Westendorf J. Davidson B.L. Huisman M.V. Sandset P.M. Moll S. Use of direct oral anticoagulants in patients with obesity for treatment and prevention of venous thromboembolism: updated communication from the ISTH SSC Subcommittee on Control of Anticoagulation. J. Thromb. Haemost. 2021; 19 (Aug): 1874-1882 Abstract Full Text Full Text PDF PubMed Scopus (65) Google Scholar ]. However, this guidance refers exclusively to VTE treatment and does not cover SPAF patients. We have previously published a report from the Dresden NOAC Registry on the impact of BMI on clinical outcomes in patients receiving any factor Xa inhibitor [ [3] Tittl L. Endig S. Marten S. Reitter A. Beyer-Westendorf I. Beyer-Westendorf J. Impact of BMI on clinical outcomes of NOAC therapy in daily care — results of the prospective Dresden NOAC Registry (NCT01588119). Int. J. Cardiol. 2018; 1 (Jul): 85-91 Abstract Full Text Full Text PDF Scopus (67) Google Scholar ]. Due to the late market entry of edoxaban, this previous analysis from our group covered only 295 edoxaban patients with a short follow-up (FU). To collect more data on the clinical impact of overweight on edoxaban treatment outcomes we extracted data from the ongoing non-interventional prospective Dresden NOAC Registry, categorized patients with edoxaban treatment into different BMI categories and evaluated thromboembolic and major bleeding events (MB) as well as all-cause mortality for each BMI class.
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