Kliniske studier vedrørende akut og kronisk tromboembolisk sygdom

A Pooled Analysis of the Global XANTUS Programme

Safety Analysis of Xarelto®:
a Pooled Analysis of the Global XANTUS Programme
 
(Real World, Prospective, Observational Studies for Stroke Prevention in Patients with Atrial Fibrillation)(Real World, Prospective, Observational Studies for Stroke Prevention in Patients with Atrial Fibrillation)

Objective1

  • To assess the global safety profile of Xarelto in routine practice through a pooled analysis of studies in the XANTUS programme, collecting information on AF patients in 47 countries

Study Design1

  • A pre-planned pooled analysis of the prospective, observational XANTUS, XANAP and XANTUS-EL studies of unselected patients with AF newly starting rivaroxaban for stroke prevention was performed
  • Patients were followed for 1 year, at ∼3-month intervals, or for ≥30 days after permanent discontinuation

Study End Points1

  • Primary outcomes were major bleeding, adverse events (AEs) or serious AEs (SAEs) and all-cause mortality
  • Secondary outcomes included symptomatic thromboembolic events and non-major bleeding
  • Treatment emergent major outcomes were adjudicated by a central independent committee

Key Findings1

  • This large analysis in >11,000 patients shows low bleeding and stroke rates in AF patients treated with Xarelto for 1 year
  • Treatment discontinuation in ∼23% of patients illustrates the need to develop care models that ensure consistent delivery of evidence-based therapy

AF, atrial fibrillation; AE, adverse event; SAE, serious adverse event.

 

PP-XAR-ALL-1815-1

Referencer

Authentication Modal