Fixed-dose, body weight-independent subcutaneous low molecular weight heparin Certoparin compared with adjusted-dose intravenous unfractionated heparin in patients with proximal deep venous thrombosis

• Verfasst von: Riess, Hanno [VerfasserIn]
• Verfasst von: Koppenhagen, Klaus [VerfasserIn]
• Verfasst von: Tolle, Alexander [VerfasserIn]
• Verfasst von: Kemkes-Matthes, Bettina [VerfasserIn]
• Verfasst von: Gräve, Michael [VerfasserIn]
• Verfasst von: Patek, Frantisek [VerfasserIn]
• Verfasst von: Drexler, Michael [VerfasserIn]
• Verfasst von: Siemens, Hans-Joachim G. [VerfasserIn]
• Verfasst von: Harenberg, Job [VerfasserIn]
• Verfasst von: Weidinger, Gottfried [VerfasserIn]
• Verfasst von: Brom, Joachim [VerfasserIn]
• Verfasst von: Haas, Sylvia [VerfasserIn]
• Titel: Fixed-dose, body weight-independent subcutaneous low molecular weight heparin Certoparin compared with adjusted-dose intravenous unfractionated heparin in patients with proximal deep venous thrombosis
• Verf.angabe: Hanno Riess, Klaus Koppenhagen, Alexander Tolle, Bettina Kemkes-Matthes, Michael Gräve, Frantisek Patek, Michael Drexler, Hans-Joachim G. Siemens, Job Harenberg, Gottfried Weidinger, Joachim Brom, Sylvia Haas
• Jahr: 2003
• Umfang: 8 S.
• Fussnoten: Elektronische Reproduktion der Druck-Ausgabe 06. Dezmber 2017 ; Gesehen am 21.04.2022
• Titel Quelle: Enthalten in: Thrombosis and haemostasis
• Ort Quelle: Stuttgart : Thieme, 1976
• Jahr Quelle: 2003
• Band/Heft Quelle: 90(2003), 08, Seite 252-259
• ISSN Quelle: 2567-689X
• DOI: doi:10.1160/TH02-09-0061
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 180000141X

Abstract

<p>Subcutaneous body weight-adjusted low molecular weight heparin (LMWH) has been proven as effective and safe as intravenous aPTT-adjusted unfractionated heparin (UFH) for the treatment of patients with acute deep venous thrombosis (DVT). In this study we evaluate the efficacy of the initial treatment of proximal DVT with a fixed-dose, body weight-independent application of the LMWH Certoparin with a six month follow-up.</p> <p>In a prospective, multicentre, randomized, active-controlled study 1220 patients with objectively diagnosed proximal DVT were randomly assigned to subcutaneous 8000 U anti-factor Xa of Certoparin twice daily for 10 to 14 days or intravenous aPTT-adjusted UFH for 5 to 8 days. Both regimen were followed by oral anticoagulation for 6 months. The primary end point was the rate of symptomatic and objectively confirmed thromboembolic events within 6 months. The aim of the study was to demonstrate the non-inferiority of the Certoparin regimen as compared to UFH.</p> <p>The per-protocol analysis revealed 22 (3.8%) thromboembolic events in the Certoparin group and 24 (4.3%) in patients assigned to UFH within 6 months, thereby proving the non-inferiority (p<0.01), confirmed by intent-to-treat analysis (p<0.001). Major bleeding occurred in 6 and 7 patients started on Certoparin or UFH during the treatment period. Thromboembolic events were equally distributed in body weight categories with < 50,50-80 and >80 kg as followed:0,3.6% and 4.1% of patients for the Certoparin group and 0, 4.6% and 4.2% of patients for the UFH group. The same was true for major bleeding complications with 0, 2.9% and 1.5% for Certoparin and 0, 3.5% and 4.2% for UFH. Overall mortality was 1.9 % in the Certoparin group and 2.7 % in the UFH group.</p> <p>Fixed-dose body weight-independent subcutaneous LMWH Certoparin is at least as efficacious and safe as intravenous aPTT-adjusted UFH for the initial treatment of acute proximal DVT. This effect is maintained during a 6-months follow-up of treatment with oral anticoagulation.</p>