Efficacy and Safety of DOACs vs Warfarin in AF Patients with T2DM

Sarfaroj Khan 


December 18, 2020


Why this matters

  • The evidence on DOACs’ effectiveness and safety in patients with AF and T2DM from clinical practices is still limited.

  • Post-hoc analysis of clinical trials show that the effectiveness and safety of DOACs extend to patients with both conditions.

Study design

  • This retrospective cohort study included 8555 treatment-naïve patients with AF and T2DM using data from the UK Clinical Practice Research Datalink (CPRD; 2011-2018).

  • Main efficacy outcome: composite of ischaemic stroke, unspecified stroke and haemorrhagic stroke; secondary efficacy outcome: myocardial infarction (MI).

  • Safety outcomes: major bleeding (composite of intracranial bleeding, gastrointestinal [GI] bleeding and bleeding on other clinically relevant sites).

  • Funding: None.

Key results

  • Overall, 3437 (40.18%) patients were prescribed a DOAC and 5118 (59.82%) warfarin.

  • No significant differences were seen between DOACs and warfarin in the risk of:

    • any stroke (adjusted HR [aHR], 1.15; 95% CI, 0.82-1.60);

    • ischaemic and unspecified stroke (aHR, 1.23; 95% CI, 0.86-1.76);

    • haemorrhagic stroke (aHR, 0.75; 95% CI, 0.30-1.85); and

    • MI (aHR, 1.39; 95% CI, 0.99-1.97).

  • Similarly, no significant differences were seen in the risk of:

    • major bleeding (aHR, 0.83; 95% CI, 0.68-1.03);

    • intracranial bleeding (aHR, 0.66; 95% CI, 0.34-1.30);

    • GI bleeding (aHR, 0.88; 95% CI, 0.60-1.30); and

    • bleeding on other clinically relevant sites (aHR, 0.89; 95% CI, 0.60-1.31).

  • In subgroup analyses stratified by gender and diabetes severity, the risk of stroke and bleeding remained consistent.


  • Retrospective design.


Rustem Gulluoglu F, Souverein PC, van den Ham HA, de Boer A, Komen J. Comparative effectiveness and safety of direct oral anticoagulants versus warfarin in UK patients with atrial fibrillation and type 2 diabetes: a retrospective cohort study. Pharmacoepidemiol Drug Saf. 2020 Dec 11 [Epub ahead of print]. doi: 10.1002/pds.5181. PMID: 33314401 View abstract

This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.


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