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Oral rivaroxaban for the treatment of symptomatic pulmonary embolism.

AbstractBACKGROUND:
A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism.
METHODS:
In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding.
RESULTS:
Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups.
CONCLUSIONS:
A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).
AuthorsEINSTEIN–PE Investigators, Harry R Büller, Martin H Prins, Anthonie W A Lensin, Hervé Decousus, Barry F Jacobson, Erich Minar, Jaromir Chlumsky, Peter Verhamme, Phil Wells, Giancarlo Agnelli, Alexander Cohen, Scott D Berkowitz, Henri Bounameaux, Bruce L Davidson, Frank Misselwitz, Alex S Gallus, Gary E Raskob, Sebastian Schellong, Annelise Segers
JournalThe New England journal of medicine (N Engl J Med) Vol. 366 Issue 14 Pg. 1287-97 (04 05 2012) ISSN: 1533-4406 [Electronic] United States
PMID22449293 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticoagulants
  • Enoxaparin
  • Morpholines
  • Thiophenes
  • Vitamin K
  • Rivaroxaban
Topics
  • Administration, Oral
  • Aged
  • Anticoagulants (adverse effects, therapeutic use)
  • Drug Therapy, Combination
  • Enoxaparin (adverse effects, therapeutic use)
  • Female
  • Follow-Up Studies
  • Hemorrhage (chemically induced)
  • Humans
  • International Normalized Ratio
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Morpholines (adverse effects, therapeutic use)
  • Pulmonary Embolism (drug therapy, mortality)
  • Recurrence
  • Rivaroxaban
  • Thiophenes (adverse effects, therapeutic use)
  • Treatment Outcome
  • Vitamin K (antagonists & inhibitors)

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