Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis: A randomized trial

Harry R. Büller, Bruce L. Davidson, Hervé Decousus, Alexander Gallus, Michael Gent, Franco Piovella, Martin H. Prins, Gary Raskob, Annelise E M Segers, Roger Cariou, Oscar Leeuwenkamp, Anthonie W A Lensing

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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. Design: Randomized, double-blind study. Setting: 154 centers worldwide. Patients: 2205 patients with acute symptomatic deep venous thrombosis. Intervention: Fondaparinux, 7.5 mg (5.0 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. Measurements: 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. Limitations: 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.

Original languageEnglish
JournalAnnals of Internal Medicine
Volume140
Issue number11
Publication statusPublished - Jun 1 2004

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Enoxaparin
Thrombosis
Venous Thrombosis
Therapeutics
Low Molecular Weight Heparin
Safety
fondaparinux
Body Weight
Dalteparin
Hemorrhage
International Normalized Ratio
Vitamin K
Double-Blind Method
Heparin

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Büller, H. R., Davidson, B. L., Decousus, H., Gallus, A., Gent, M., Piovella, F., ... Lensing, A. W. A. (2004). Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis: A randomized trial. Annals of Internal Medicine, 140(11).

Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis : A randomized trial. / Büller, Harry R.; Davidson, Bruce L.; Decousus, Hervé; Gallus, Alexander; Gent, Michael; Piovella, Franco; Prins, Martin H.; Raskob, Gary; Segers, Annelise E M; Cariou, Roger; Leeuwenkamp, Oscar; Lensing, Anthonie W A.

In: Annals of Internal Medicine, Vol. 140, No. 11, 01.06.2004.

Research output: Contribution to journalArticle

Büller, HR, Davidson, BL, Decousus, H, Gallus, A, Gent, M, Piovella, F, Prins, MH, Raskob, G, Segers, AEM, Cariou, R, Leeuwenkamp, O & Lensing, AWA 2004, 'Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis: A randomized trial', Annals of Internal Medicine, vol. 140, no. 11.
Büller, Harry R. ; Davidson, Bruce L. ; Decousus, Hervé ; Gallus, Alexander ; Gent, Michael ; Piovella, Franco ; Prins, Martin H. ; Raskob, Gary ; Segers, Annelise E M ; Cariou, Roger ; Leeuwenkamp, Oscar ; Lensing, Anthonie W A. / Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis : A randomized trial. In: Annals of Internal Medicine. 2004 ; Vol. 140, No. 11.
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title = "Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous 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. Design: Randomized, double-blind study. Setting: 154 centers worldwide. Patients: 2205 patients with acute symptomatic deep venous thrombosis. Intervention: Fondaparinux, 7.5 mg (5.0 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. Measurements: 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. Limitations: 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.",
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T1 - Fondaparinux or enoxaparin for the initial treatment of symptomatic deep vienous thrombosis

T2 - A randomized trial

AU - Büller, Harry R.

AU - Davidson, Bruce L.

AU - Decousus, Hervé

AU - Gallus, Alexander

AU - Gent, Michael

AU - Piovella, Franco

AU - Prins, Martin H.

AU - Raskob, Gary

AU - Segers, Annelise E M

AU - Cariou, Roger

AU - Leeuwenkamp, Oscar

AU - Lensing, Anthonie W A

PY - 2004/6/1

Y1 - 2004/6/1

N2 - 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. Design: Randomized, double-blind study. Setting: 154 centers worldwide. Patients: 2205 patients with acute symptomatic deep venous thrombosis. Intervention: Fondaparinux, 7.5 mg (5.0 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. Measurements: 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. Limitations: 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.

AB - 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. Design: Randomized, double-blind study. Setting: 154 centers worldwide. Patients: 2205 patients with acute symptomatic deep venous thrombosis. Intervention: Fondaparinux, 7.5 mg (5.0 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. Measurements: 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. Limitations: 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.

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