Apixaban and rivaroxaban use for atrial fibrillation in patients with obesity and BMI ≥50 kg/m<sup>2</sup>

O'Kane, Cavan; Avalon, Juan Carlo; Lacoste, Jordan L.; Fang, Wei; Bianco, Christopher; Davisson, Laura; Piechowski, Kara

doi:10.1002/phar.2651

Cited by 13 publications

(8 citation statements)

References 30 publications

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“…In other words, despite exposure being slightly reduced, no dose adjustment was required [20]. However, this does not dismiss the claim that the morbidly obese category had the most incidence of thrombotic events among the BMI classes [8,9,21,22].…”

Section: Discussionmentioning

confidence: 97%

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Nwanosike,

Merchant,

Sunter

et al. 2023

Eur J Clin Pharmacol

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Objective Through predictable pharmacokinetics—including a convenient fixed-dose regimen, direct oral anticoagulants (DOACs) are preferred over previous treatments in anticoagulation for various indications. However, the association between higher body weight and the risk of adverse consequences is not well studied among DOAC users. We aim to explore the association of body weight and adverse clinical outcomes in DOAC users. Methods A total of 97,413 anonymised DOAC users in a tertiary care setting were identified following structured queries on the electronic health records (EHRs) to extract the feature-rich anonymised dataset. The prepared dataset was analysed, and the features identified with machine learning (ML) informed the adjustments of covariates in the multivariate regression analysis to examine the association. Kaplan–Meier analysis was performed to evaluate the mortality benefits of DOACs. Results Among DOAC users, the odds of adverse clinical outcomes, such as clinically relevant non-major bleeding (CRNMB), ischaemic stroke, all-cause mortality, and prolonged hospital stay, were lower in patients with overweight, obesity, or morbid obesity than in patients with normal body weight. The odds of ischaemic stroke (OR 0.42, 95% CI: 0.36–0.88, p = 0.001) and all-cause mortality (OR 0.87, 95% CI: 0.81–0.95, p = 0.001) were lower in patients with morbid obesity than in patients with normal body weight. In the Kaplan–Meier analysis, apixaban was associated with a significantly lower rate of mortality overall and in obesity and overweight subgroups than other DOACs (p < 0.001). However, rivaroxaban performed better than apixaban in the morbid obesity subgroup (p < 0.001). Conclusion This study shows the positive effects of DOAC therapy on clinical outcomes, particularly in patients with high body weight. However, this still needs validation by further studies particularly among patients with morbid obesity.

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Section: Discussionmentioning

confidence: 97%

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Nwanosike,

Merchant,

Sunter

et al. 2023

Eur J Clin Pharmacol

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“…11 A more recently published cohort study of 595 patients on apixaban or rivaroxaban in patients with BMI 50 kg/m 2 or greater found similar rates of thromboembolic events and bleeding after 1619 patient years of follow-up when compared to patients with BMI <30 kg/m 2 . 12 A study using the ARISTOTLE trial data displayed improved outcomes of stroke or systemic embolism, myocardial infarction, and all-cause mortality in AF patients with higher BMI (25 to <30 kg/m 2 or ≥30 kg/m 2 ) compared to patients with healthy BMI (<25 kg/m 2 ). 13 Several recent publications have compared the use of warfarin to apixaban in an obese patient population.…”

Section: Discussionmentioning

confidence: 99%

Observed Apixaban Anti-Xa Levels in Obese Patients

et al. 2022

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Background: Recent guidelines suggest that, for venous thromboembolism (VTE), standard doses of apixaban are appropriate in patients with body mass index (BMI) >40 kg/m2 or >120 kg. Atrial fibrillation (AF) is excluded from this recommendation. Objective: The goals of our study were to measure and describe anti-Xa levels of patients with a BMI ≥40 kg/m2 and/or a weight ≥120 kg with a clinical indication of AF or VTE who were treated with apixaban, and to determine whether BMI or weight are associated with anti-Xa levels in this population. Methods We conducted an observational cohort study at a single health care system in Oregon, USA. Patients meeting enrollment criteria were recruited and had peak and trough apixaban anti-Xa levels drawn. Results Of 55 patients enrolled, 5 (9%) had peak anti-Xa levels below the reference range and 3 (6%) had trough anti-Xa levels below the reference range. BMI did not significantly correlate with peak or trough anti-Xa levels (r = −0.10, p = 0.45 and r = −0.14, p = 0.31). Weight had a moderate, negative correlation with peak anti-Xa levels (r = −0.42, p = 0.002) and a weak, negative correlation with trough anti-Xa levels (r = −0.32, p = 0.02). Conclusions and Relevance This study provides evidence that anti-Xa levels among obese patients are not substantially different from patients with nomral BMI and weight. This supports recent ISTH guidance for standard dosing of apixaban for VTE patients with BMI >40 kg/m2 or weight >120 kg and provides additional evidence that the standard dosing may also be appropriate in patients with AF.

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“…A retrospective cohort study 50 evaluated the effectiveness and safety of rivaroxaban and apixaban in 299 adult patients with BMI ≥50 kg/m 2 compared with a cohort of 296 patients with BMI 18 to 30 kg/m 2 . The primary endpoint of incidence of ischemic stroke was numerically similar in both groups: 1.3 per 100 patient-years in the BMI ≥50 kg/m 2 group compared with 2.0 per 100 patient-years in the BMI <30 kg/m 2 group (RR: 0.65, 95% CI: 0.38–1.82).…”

Section: Doacs For Cardioembolic Stroke Prophylaxis In Obese Patients...mentioning

confidence: 99%

Direct-Acting Oral Anticoagulants in patients at extremes of body weight: a review of pharmacological considerations and clinical implications

Talerico,

Pola,

Klok

et al. 2024

TH Open

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Patients at extremes of body weight are underrepresented in randomized controlled trials of direct-acting oral anticoagulants (DOACs). Therefore, their optimal anticoagulant treatment remains a topic of debate.The aim of this narrative review is to summarize the evidence on the pharmacokinetic and pharmacodynamic profile of DOACs for treating patients at extremes of body weight in venous thromboembolism (VTE) and in the prevention of cardioembolic stroke in nonvalvular atrial fibrillation (NVAF). A literature search was conducted in the main bibliographic databases, and the most relevant reviews and original articles on the topic were selected.Although data in these patient groups are limited, apixaban and rivaroxaban show a favorable pharmacokinetic and pharmacodynamic profile in obese VTE treatment and NVAF patients and, in the case of apixaban, also in underweight patients. In particular, these drugs demonstrated comparable efficacy and safety to standard therapy. Very few data were available for dabigatran and edoxaban; the latter drug was safer at a lower dose, mainly in underweight patients.Our findings are in line with the last International Society of Haemostasis and Thrombosis position paper and European Heart Rhythm Association 2021 practical guide, suggesting the use of apixaban and rivaroxaban in morbidly obese patients (>120 kg or body mass index ≥40 kg/m2) and the reduced dosage of edoxaban in low-weight patients. Future studies should focus on large populations of patients at extremes of body weights to acquire more clinical and pharmacokinetic evidence on all available DOACs, especially those currently less investigated.

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Apixaban and rivaroxaban use for atrial fibrillation in patients with obesity and BMI ≥50 kg/m²

Cited by 13 publications

References 30 publications

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Observed Apixaban Anti-Xa Levels in Obese Patients

Direct-Acting Oral Anticoagulants in patients at extremes of body weight: a review of pharmacological considerations and clinical implications

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Apixaban and rivaroxaban use for atrial fibrillation in patients with obesity and BMI ≥50 kg/m2

Cited by 13 publications

References 30 publications

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Direct oral anticoagulants and the risk of adverse clinical outcomes among patients with different body weight categories: a large hospital-based study

Observed Apixaban Anti-Xa Levels in Obese Patients

Direct-Acting Oral Anticoagulants in patients at extremes of body weight: a review of pharmacological considerations and clinical implications

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Apixaban and rivaroxaban use for atrial fibrillation in patients with obesity and BMI ≥50 kg/m²