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Fondaparinux for the treatment of superficial-vein thrombosis in the legs.

AbstractBACKGROUND:
The efficacy and safety of anticoagulant treatment for patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation, have not been established.
METHODS:
In a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily, or placebo for 45 days. The primary efficacy outcome was a composite of death from any cause or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47. The main safety outcome was major bleeding. The patients were followed until day 77.
RESULTS:
The primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinux group and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001). The incidence of each component of the primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the placebo group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77. A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of serious adverse events was 0.7% with fondaparinux and 1.1% with placebo.
CONCLUSIONS:
Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00443053.)
AuthorsHervé Decousus, Paolo Prandoni, Patrick Mismetti, Rupert M Bauersachs, Zoltán Boda, Benjamin Brenner, Silvy Laporte, Lajos Matyas, Saskia Middeldorp, German Sokurenko, Alain Leizorovicz,
JournalThe New England journal of medicine (N Engl J Med) Vol. 363 Issue 13 Pg. 1222-32 (Sep 23 2010) ISSN: 1533-4406 [Electronic] United States
PMID20860504 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticoagulants
  • Polysaccharides
  • fondaparinux
Topics
  • Acute Disease
  • Anticoagulants (administration & dosage, adverse effects, therapeutic use)
  • Double-Blind Method
  • Female
  • Hemorrhage (chemically induced)
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Polysaccharides (administration & dosage, adverse effects, therapeutic use)
  • Pulmonary Embolism (epidemiology, prevention & control)
  • Recurrence
  • Risk
  • Treatment Outcome
  • Venous Thrombosis (complications, drug therapy, mortality, surgery)

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