Abstract
BackgroundWe compared the risk of bleeding and cardiovascular disease (CVD) events between non-vitamin K antagonist oral anticoagulant (NOAC) and warfarin in people with type 2 diabetes (T2DM).Methods862 Incident NOAC users and 626 incident warfarin users with T2DM were identified from within 40 UK general practice (1/4/2017–30/9/2018). Outcomes included incident hospitalisation for bleeding, CVD and re-hospitalisation for CVD within 12 months since first anticoagulant prescription, identified from linked hospitalisation data. A tapered matching method was applied to form comparison cohorts: coarsened exact matching restricted the comparison to areas of sufficient overlap in missingness and characteristics: (i) demographic characteristics; (ii) clinical measurements; (iii) prior bleeding and CVD history; (iv) prescriptions with bleeding; (v) anti-hypertensive treatment(s); (vi) anti-diabetes treatment(s). Entropy balancing sequentially balanced NOAC and warfarin users on their distribution of (i–vi). Weighted logistic regression modelling estimated outcome odds ratios (ORs), using entropy balancing weights from steps i–vi.ResultsThe 12-month ORs of bleeding with NOAC (n = 582) vs matched/balanced warfarin (n = 486) were 1.93 (95% confidence interval 0.97–3.84), 2.14 (1.03–4.44), 2.31 (1.10–4.85), 2.42 (1.14–5.14), 2.41 (1.12–5.18), and 2.51 (1.17–5.38) through steps i–vi. ORs for CVD re-hospitalisation was increased with NOAC treatment through steps i–vi: 2.21 (1.04–4.68), 2.13 (1.01–4.52), 2.47 (1.08–5.62), 2.46 (1.02–5.94), 2.51 (1.01–6.20), and 2.66 (1.02–6.94).ConclusionsIncident NOAC use among T2DM is associated with increased risk of bleeding hospitalisation and CVD re-hospitalisation compared with incident warfarin use. For T2DM, caution is required in prescribing NOACs as first anticoagulant treatment. Further large-scale replication studies in external datasets are warranted.
Highlights
We compared the risk of bleeding and cardiovascular disease (CVD) events between non-vitamin K antagonist oral anticoagulant (NOAC) and warfarin in people with type 2 diabetes (T2DM)
Studies in the general population have reported potential further clinical benefits of NOACs over warfarin, for example, QResearch found potential for apixaban to be associated with a decreased risk of major bleeding events in patients with and without atrial fibrillation compared with warfarin; rivaroxaban is associated with a decreased risk of intracranial bleeding in patients without atrial fibrillation compared with warfarin; rivaroxaban and low dose apixaban are associated with an increased risk of all-cause mortality in patients with and without atrial fibrillation compared to warfarin [6]
NOAC users have a lower HbA1c with fewer existing bleeding or CVD comorbidities comparing with warfarin users (Table 1)
Summary
We compared the risk of bleeding and cardiovascular disease (CVD) events between non-vitamin K antagonist oral anticoagulant (NOAC) and warfarin in people with type 2 diabetes (T2DM). 8 years its use has been gradually replaced by non-vitamin K antagonist oral anticoagulants (NOACs) including dabigatran, rivaroxaban, and apixaban. Unlike warfarin, these drugs have set doses and do not generally require regular international normalisation ratio blood test monitoring [3]. These drugs have set doses and do not generally require regular international normalisation ratio blood test monitoring [3] They have faster onset and offset of action. Few studies have examined such associations in populations with type 2 diabetes, which is distinctively different from the general population, in terms of age, and comorbidities [9]
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