This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Join Mailing List   |   Jobs   |   Print Page   |   Contact Us   |   Sign In   |   Join
News & Press: Journals

New SSC Guidance Released by JTH on Use of DOACs in Obese Patients

Wednesday, June 15, 2016   (0 Comments)
Posted by: Luke Blount
Share |

The Journal of Thrombosis and Haemostasis (JTH) has accepted the following article on guidance from the Scientific and Standardization Committee (SSC) of the ISTH:

Use of the direct oral anticoagulants in obese patients: 
Four direct-acting oral anticoagulants (DOACs) – the thrombin inhibitor dabigatran, and the activated factor X (FXa) inhibitors apixaban, edoxaban, and rivaroxaban – are approved in many countries for the treatment of venous thromboembolism (VTE), the prevention of VTE after hip and knee arthroplasty, and ischemic stroke prevention in patients with non-valvular atrial fibrillation (AF). Because of their fixed dosing – without the need for routine monitoring – and limited dietary interactions, they are used as a convenient anticoagulant alternative to vitamin K antagonists (VKAs). In the product labeling (package inserts) of the approved DOACs, none has a dose adjustment for high weight or body mass index (BMI) in obese categories. However, there is uncertainty about their efficacy and safety in the obese population, with ‘obese’ defined by the National Institutes of Health as a BMI between 30 kg m−2 and 40 kg m−2, and ‘extreme obesity’ as a BMI of > 40 kg m−2. Although a recent publication has suggested recommendations for use of DOACs in the obese population [1], data from clinical outcomes studies and pharmacokinetic (PK)/pharmacodynamic (PD) studies regarding the efficacy and safety of DOACs in obese patients are limited. We reviewed the available data on the use of DOACs in obese patients through a PubMed search of key terms, including each DOAC in combination with the terms ‘pharmacokinetic’, ‘pharmacodynamic’, ‘drug level’, ‘VTE’, ‘VTE prophylaxis’, and ‘atrial fibrillation’. Data on obese patients in phase III clinical trials were pooled by anticoagulation indication to obtain risk ratios for DOACs versus VKAs. Guidance statements were then developed to provide practical guidance for clinicians regarding the use of DOACs in obese patients. Read more.

Membership Management Software Powered by YourMembership  ::  Legal