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10.1111/bcp.12836

http://scihub22266oqcxt.onion/10.1111/bcp.12836
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suck abstract from ncbi


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pmid26580706
      Br+J+Clin+Pharmacol 2016 ; 81 (4 ): 724-34
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  • Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co-medication interactions #MMPMID26580706
  • Kreutz R ; Haas S ; Holberg G ; Lassen MR ; Mantovani LG ; Schmidt A ; Turpie AG
  • Br J Clin Pharmacol 2016[Apr]; 81 (4 ): 724-34 PMID26580706 show ga
  • 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.
  • |Aged [MESH]
  • |Anticoagulants/administration & dosage/adverse effects/*therapeutic use [MESH]
  • |Arthroplasty, Replacement, Hip/*methods [MESH]
  • |Arthroplasty, Replacement, Knee/*methods [MESH]
  • |Cohort Studies [MESH]
  • |Drug Interactions [MESH]
  • |Female [MESH]
  • |Hemorrhage/chemically induced [MESH]
  • |Humans [MESH]
  • |Male [MESH]
  • |Middle Aged [MESH]
  • |Rivaroxaban/administration & dosage/adverse effects/*therapeutic use [MESH]


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