How Safe Are DOACs in Obesity?

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Lauren Igneri
Critical care pharmacist and proud Rutgers University graduate. Enjoys rock climbing, cycling, travel, and lively discussions on the finer points of pharmacokinetics and critical care over a beer with friends.

The Pre-brief

  • In 2017-2018, 42.4% of US adults were obese (BMI ≥30 kg/m2), with 9.2% meeting the criteria for severe obesity (BMI ≥40 kg/m2).1 Women had a higher prevalence of severe obesity (11.5%) than men (6.9%), with adults 40-59 years old having the highest prevalence (11.5%).1 Obesity is associated with an increased risk of venous thromboembolism (VTE) and atrial fibrillation (AF).2,3
  • Direct-acting oral anticoagulants (DOACs) are now recommended as first-line agents for the treatment of VTE and for stroke prevention in AF in the most updated guidelines.4,5,6
  • Obesity is underrepresented in prospective clinical trials, so the question is often asked “Can we use a DOAC in a patient with a BMI ≥40 kg/m2 without impacting efficacy or safety?”

The Debrief

  • While there is only limited, low-quality data available, it appears that patients with severe obesity have similar efficacy and bleeding rates with rivaroxaban and apixaban as compared to the general population evaluated in clinical trials.7
  • Median BMI in the retrospective review data evaluating DOAC use in severe obesity is ~45, with only ~20-30% patients having BMI ≥50 kg/m2. Findings are likely best applied to those with a BMI ranging between 40-50 kg/m2.7
  • Further clarity needed for those with BMI >50 kg/m2.

References

  1. Hales CM, Carroll MD, Fryar CD, Ogden CL. Prevalence of obesity among adults and youth: United States, 2017-2018. NCHS Data Brief No. 360. https://www.cdc.gov/nchs/products/databriefs/db360.htm. Accessed December 11, 2020.
  2. Ageno W, Becattini C, Brighton T, et al. Cardiovascular risk factors and venous thromboembolism: a meta-analysis. Circulation. 2008; 117:93-102. 
  3. Wanahita N, Messerli FH, Bangalore S, et al. Atrial fibrillation and obesity-results of a meta-analysis. Am Heart J. 2008;155(2):310-5.
  4. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016; 149:315-352.
  5. Hindricks G, Potpara T, Dagres N, et al. ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2020 Aug 29:ehaa612.
  6. Ortel TL, Neumann I, Ageno W, et al. American Society of Hematology 2020 guidelines for the management of venous thromboembolism: treatment of deep vein thrombosis and pulmonary embolism. Blood Adv. 2020; 19:4693-738.
  7. Kushnir M, Choi Y, Eisenberg R, et al. Efficacy and safety of direct oral factor Xa inhibitors compared with warfarin in patients with morbid obesity: a single-centre, retrospective analysis of chart data. Lancet Haematol. 2019; 6:e359-65.

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