Concomitant use of levetiracetam with apixaban (ROR 2.29; 95% CI 1.56-3.38) or rivaroxaban (ROR 3.81), and valproic acid with rivaroxaban, increased thromboembolic event risk.
Observational
Does co-treatment with anti-seizure medications and FXa-DOACs increase the risk of thromboembolic events?
Concomitant use of levetiracetam or valproic acid with FXa-DOACs (apixaban or rivaroxaban) is associated with an increased risk of thromboembolic events based on pharmacovigilance data.
Estimación del efecto: ROR 2.29 (95% CI 1.56-3.38)
BACKGROUND: Limited data have raised concerns about an increased risk of thromboembolic adverse events in atrial fibrillation (AF) patients co-treated with factor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) and anti-seizure medications (ASMs). However, evidence regarding this association remains controversial. OBJECTIVES: This study aims to investigate the impact of ASMs on the reporting of thromboembolic events in FXa-DOAC-treated patients. METHODS: This study analyzed data from the FDA Adverse Event Reporting System (FAERS) between 2011Q3 and 2024Q1 using the weighted composite score integrated by four pharmacovigilance signals reporting odds ratio (ROR), Empirical Bayes Geometric Mean (EBGM), additive model and multiplicative model. RESULTS: A total of 177 cases of thromboembolic events were identified in patients using combined FXa-DOACs and ASMs. Levetiracetam together with FXa-DOACs was associated with an increased risk of thromboembolic events, particularly apixaban (ROR: 2.29, 95%CI 1.56-3.38; EBGM05:1.32; additive model:0.14 > 0; multiplicative mode: 2.47 > 1;composite score:1) and rivaroxaban (ROR:3.81, 95% CI 2.77-5.26; EBGM05:1.99; additive model:0.13; multiplicative model:1.71; composite score:1). Valproic acid was associated with thromboembolic risk when with rivaroxaban (ROR:4.80, 95%CI 2.50-9.19; EBGM05:1.64; additive model:0.29; multiplicative model:8.48; composite score:1). CONCLUSION: This study suggests that the concomitant use of levetiracetam and valproic acid with FXa-DOACs is associated with an increased risk of thromboembolic events.
Ding et al. (Wed,) conducted a observational in Atrial fibrillation. Factor Xa-inhibiting direct oral anticoagulants (FXa-DOACs) and anti-seizure medications (ASMs) was evaluated on Thromboembolic events (ROR 2.29, 95% CI 1.56-3.38). Concomitant use of levetiracetam with apixaban (ROR 2.29; 95% CI 1.56-3.38) or rivaroxaban (ROR 3.81), and valproic acid with rivaroxaban, increased thromboembolic event risk.