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SHR Neuro Cancer Cardio Lipid Metab Microb

Büller, HR; Davidson, BL; Decousus, H; Gallus, A; Gent, M; Piovella, F; Prins, MH; Raskob, G; Segers, AE; Cariou, R; Leeuwenkamp, O; Lensing, AW; Matisse Investigators (with Pilger, E).
Fondaparinux or enoxaparin for the initial treatment of symptomatic deep venous thrombosis: a randomized trial.
Ann Intern Med. 2004; 140(11): 867-873. Doi: 10.7326/0003-4819-140-11-200406010-00007 [OPEN ACCESS]
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Study Group Members Med Uni Graz:: Pilger Ernst
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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 <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. 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.
Find related publications in this database (using NLM MeSH Indexing): Aged -; Body Weight -; Cause of Death -; Double-Blind Method -; Drug Administration Schedule -; Enoxaparin - administration and dosage; Female - administration and dosage; Fibrinolytic Agents - administration and dosage; Hemorrhage - chemically induced; Humans - chemically induced; Kidney - metabolism; Male - metabolism; Middle Aged - metabolism; Polysaccharides - administration and dosage; Recurrence - administration and dosage; Treatment Outcome - administration and dosage; Venous Thrombosis - drug therapy; Vitamin K - antagonists and inhibitors