Key result
Concomitant NSAID use linked to ~50% higher major bleeding risk in patients taking rivaroxaban.
Why the study?
Does concomitant use of NSAIDs or platelet aggregation inhibitors alter the efficacy and safety of rivaroxaban compared to standard of care for VTE prophylaxis after major orthopaedic surgery?
Observational (n=17,701)
Does concomitant use of NSAIDs or platelet aggregation inhibitors alter the efficacy and safety of rivaroxaban compared to standard of care for VTE prophylaxis after major orthopaedic surgery?
Concomitant NSAID use increases major bleeding risk during post-surgical thromboprophylaxis with either rivaroxaban or standard of care, without altering the comparative benefit-risk profile of rivaroxaban.
Answers are grounded in this paper and cite their sources.
NSAID co-use may raise major bleeding risk with rivaroxaban or SOC; leaves open interaction effects in randomized post-orthopaedic VTE prophylaxis.
AIM: The aim of the present study was to analyse concomitant drug use and its association with outcome in patients (N = 17 701) receiving rivaroxaban or standard of care (SOC) for the prevention of venous thromboembolism after major orthopaedic surgery in the non-interventional, phase IV XAMOS (Xarelto® in the prophylaxis of post-surgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study. METHODS: Concomitant drug use was at the discretion of the treating physician. Prespecified co-medications of interest were cytochrome P450 (CYP) 3A4/P-glycoprotein inhibitors/inducers, platelet aggregation inhibitors (PAIs) and nonsteroidal anti-inflammatory drugs (NSAIDs). Crude event incidences were compared between rivaroxaban and SOC groups. RESULTS: CYP3A4/P-glycoprotein inhibitor/inducer use was infrequent, in contrast to PAI (~7%) and NSAID (~52%) use. Rivaroxaban was associated with a lower incidence of overall symptomatic thromboembolic events compared with SOC, regardless of co-medication use. In both treatment groups, PAI users, with higher age and prevalence of cardiovascular co-morbidities, had similar higher (>7-fold) incidences of symptomatic arterial but not venous thromboembolic events compared with non-users. NSAID use had no influence on thromboembolic events. However, odds ratios (ORs) for major bleeding events (European Medicines Agency definition) were higher in NSAID users compared with non-users in rivaroxaban [OR = 1.50; 95% confidence interval (CI) 1.06, 2.13] and SOC (OR = 1.70; CI 1.16, 2.49) groups. In PAI users, ORs for major bleeding events were no different from those of non-users in both the rivaroxaban (OR = 1.49; CI 0.84, 2.65) and SOC (OR = 1.46; CI 0.82, 2.62) groups. CONCLUSIONS: Use of NSAIDs in XAMOS was frequent and associated with a higher frequency of bleeding events in patients receiving rivaroxaban or SOC, although the benefit-risk profile of rivaroxaban compared with SOC was maintained.
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Kreutz et al. (2015) conducted an observational in venous thromboembolism after major orthopaedic surgery (n=17,701). NSAID use vs. Non-NSAID use was evaluated on Major bleeding events in the rivaroxaban group (OR 1.50, 95% CI 1.06-2.13). Concomitant NSAID use was associated with higher odds of major bleeding in patients receiving rivaroxaban (OR 1.50; 95% CI 1.06-2.13) or standard of care (OR 1.70; 95% CI 1.16-2.49).
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