Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY

Cohen, Alexander T.; Pan, Sharon; Byon, Wonkyung; Ilyas, Bushra S; Taylor, T.A.; Lee, Theodore C.

doi:10.1007/s12325-021-01716-8

Cited by 27 publications

(18 citation statements)

References 21 publications

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“…Post hoc analyses of both the AMPLIFY and ARISTOTLE trials concluded that, when compared with warfarin, apixaban had superior efficacy and safety outcomes in obese and morbidly obese groups. 14,15 This is further supported by a large retrospective study that concluded DOACS were associated with better efficacy and safety compared to warfarin across all BMIs, including in patients with BMI >40 kg/m 2 . 16 Additional retrospective studies of patients with a BMI >40 kg/m 2 or who weigh >100 to 300 kg have reported similar rates of recurrent thrombotic events and bleeding for those taking apixaban compared to those taking warfarin.…”

Section: Discussionmentioning

confidence: 83%

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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Section: Discussionmentioning

confidence: 83%

Observed Apixaban Anti-Xa Levels in Obese Patients

et al. 2022

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“…1 ). Eight studies were selected in the final analysis: 1 post hoc analysis [ 14 ] and 7 retrospective cohort studies [ 15 , 20 – 25 ]. Two studies originally [ 20 , 21 ] included patients with BMI > 30 kg/m 2 , so data from their subgroup analyses of patients with BMI > 40 kg/m 2 were used.…”

Section: Resultsmentioning

confidence: 99%

“…A total of 30,895 patients were studied, with 12,755 patients (41.3%) receiving xabans and 18,140 patients (58.7%) receiving VKAs. Three studies [ 15 , 21 , 25 ] solely included patients who received rivaroxaban in the case group, while 3 studies [ 14 , 20 , 22 ] included only those who received apixaban. The remaining 2 studies [ 23 , 24 ] included different proportions of rivaroxaban, apixaban, and edoxaban.…”

Section: Resultsmentioning

confidence: 99%

“…In this study, morbid obesity was defined as BMI ≥ 40 kg/m 2 or body weight ≥ 120 kg. The cut-off of 120 kg in defining morbid obesity was used in accordance with the ISTH guidelines and many previous studies [ 8 , 14 – 16 ]. VTE recurrence was defined as new or worsening deep vein thrombosis or pulmonary embolism proven by imaging studies or clinical judgment.…”

Section: Methodsmentioning

confidence: 99%

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Factor Xa inhibitors versus vitamin K antagonist in morbidly obese patients with venous thromboembolism: a systematic review and meta-analysis

Park

Arif

et al. 2023

BMC Cardiovasc Disord

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Introduction Guidelines have endorsed non-vitamin K antagonist oral anticoagulants (NOACs), consisting of factor Xa inhibitors (xabans) and direct thrombin inhibitors, as the first line of treatment in venous thromboembolism (VTE) and atrial fibrillation. However, morbidly obese patients were under-represented in landmark trials of NOACs. Therefore, this study aimed to systematically review and perform a meta-analysis of studies on xabans versus vitamin K antagonist (VKA) in this high-risk population with VTE. Methods PubMed, Embase, Medline, Cochrane library, and Google Scholar databases were searched to identify studies that compared xabans and VKA in treating morbidly obese patients with VTE. Morbid obesity was defined as body weight ≥ 120 kg or BMI ≥ 40 kg/m2. Outcomes of interest included recurrent VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB). Results Eight studies comprising 30,895 patients were included. A total of 12,755 patients received xabans while 18,140 received VKAs. No significant difference in the odds of recurrent VTE (OR 0.75, 95% CI 0.55–1.01) and CRNMB (OR 0.69, 95% CI 0.44–1.09) was observed between the xabans group and the VKA group. However, the xabans group was associated with lower odds of major bleeding (OR 0.70, 95% CI 0.59–0.83). Conclusion Xabans have lower odds of major bleeding but similar odds of recurrent VTE when compared with VKAs in treating VTE in morbidly obese patients. Large registry analyses or future randomized controlled trials will be helpful in confirming these findings.

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“…More investigation should be done debating whether warfarin or NVKAs are the better choice for high risk VTE patients. According to the linked studies, DOACs remain to be the preferable choice regardless, due to their rapid onset of action, standard dosages without the need of titration, lack of requirement of routine check-ups, and limited interactions with food and associated drugs [ [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] , [42] , [43] , [44] , [45] , [46] , [47] , [48] , [49] , [50] , [51] , [52] , [53] , [54] , [55] , [56] , [57] ].…”

Section: Discussionmentioning

confidence: 99%