title: Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.
abstract: BACKGROUND
  The current standard initial therapies for deep venous thrombosis are low-molecular-weight heparin and unfractionated heparin. In a dose-ranging study of patients with symptomatic deep venous thrombosis, fondaparinux had efficacy and a safety profile similar to those of low-molecular-weight heparin (dalteparin).
  
  
  OBJECTIVE
  To evaluate whether fondaparinux has efficacy and safety similar to those of enoxaparin in patients with deep venous thrombosis.
  
  
  METHODS
  Randomized, double-blind study.
  
  
  METHODS
  154 centers worldwide.
  
  
  METHODS
  2205 patients with acute symptomatic deep venous thrombosis.
  
  
  METHODS
  Fondaparinux, 7.5 mg (5.0 mg in patients weighing <50 kg and 10.0 mg in patients weighing >100 kg) subcutaneously once daily, or enoxaparin, 1 mg/kg of body weight, subcutaneously twice daily for at least 5 days and until vitamin K antagonists induced an international normalized ratio greater than 2.0.
  
  
  METHODS
  The primary efficacy outcome was the 3-month incidence of symptomatic recurrent venous thromboembolic complications. The main safety outcomes were major bleeding during initial treatment and death. An independent, blinded committee adjudicated all outcomes.
  
  
  RESULTS
  43 (3.9%) of 1098 patients randomly assigned to fondaparinux had recurrent thromboembolic events compared with 45 (4.1%) of 1107 patients randomly assigned to enoxaparin (absolute difference, -0.15 percentage point [95% CI, -1.8 to 1.5 percentage points]). Major bleeding occurred in 1.1% of patients receiving fondaparinux and 1.2% of patients receiving enoxaparin. Mortality rates were 3.8% and 3.0%, respectively.
  
  
  CONCLUSIONS
  Follow-up was incomplete in 0.4% of fondaparinux-treated patients and 1.0% of enoxaparin-treated patients.
  
  
  CONCLUSIONS
  Once-daily subcutaneous fondaparinux was at least as effective (not inferior) and safe as twice-daily, body weight-adjusted enoxaparin in the initial treatment of patients with symptomatic deep venous thrombosis.
authors.affiliation: Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Harry R
authors.initials: HR
authors.lastname: Büller
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Davidson
authors.forename: Hervé
authors.initials: H
authors.lastname: Decousus
authors.forename: Alexander
authors.initials: A
authors.lastname: Gallus
authors.forename: Michael
authors.initials: M
authors.lastname: Gent
authors.forename: Franco
authors.initials: F
authors.lastname: Piovella
authors.forename: Martin H
authors.initials: MH
authors.lastname: Prins
authors.forename: Gary
authors.initials: G
authors.lastname: Raskob
authors.forename: Annelise E M
authors.initials: AE
authors.lastname: Segers
authors.forename: Roger
authors.initials: R
authors.lastname: Cariou
authors.forename: Oscar
authors.initials: O
authors.lastname: Leeuwenkamp
authors.forename: Anthonie W A
authors.initials: AW
authors.lastname: Lensing
mesh_terms: D000368:Aged; D001835:Body Weight; D002423:Cause of Death; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000077425:Fondaparinux; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007668:Kidney / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D012008:Recurrence; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000188:drug therapy* / Q000401:mortality; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D017984:Enoxaparin; D005343:Fibrinolytic Agents; D011134:Polysaccharides; D014812:Vitamin K; D000077425:Fondaparinux