HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Subcutaneous recombinant hirudin (HBW 023) versus intravenous sodium heparin in treatment of established acute deep vein thrombosis of the legs: a multicentre prospective dose-ranging randomized trial. International Multicentre Hirudin Study Group.

Abstract
The aim of this multicentre, prospective, randomised, dose-ranging study was to compare the safety and efficacy of subcutaneous recombinant hirudin (HBW 023) against intravenous sodium heparin in acute lower limb deep venous thrombosis (DVT). Patients were randomized to treatment with either HBW 023 or heparin for 5 +/- 1 days. HBW 023 was given according to body-weight in three dose groups. Thromboembolic disease was assessed by phlebography and ventilation/perfusion (V/Q) scanning on Day 1 and Day 5 +/- 1. One hundred and fifty-five patients were enrolled, of these 121 were evaluable for efficacy analysis. Significantly fewer patients on HBW 023 developed new V/Q abnormalities during the treatment period, (p = 0.006). There was no difference between the groups in thrombus extension or regression, major bleeding complications or serious adverse events. There were significantly fewer findings of new V/Q mismatch after treatment with HBW 023, and anticoagulant control was superior in these patients.
AuthorsF Schiele, F Lindgaerde, H Eriksson, J P Bassand, A Wallmark, P O Hansson, G Grollier, M Sjo, M Moia, A Camez, V Smyth, M Walker
JournalThrombosis and haemostasis (Thromb Haemost) Vol. 77 Issue 5 Pg. 834-8 (May 1997) ISSN: 0340-6245 [Print] Germany
PMID9184388 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Fibrinolytic Agents
  • Hirudins
  • Recombinant Proteins
  • Heparin
Topics
  • Adult
  • Aged
  • Dose-Response Relationship, Drug
  • Female
  • Fibrinolytic Agents (adverse effects, pharmacokinetics, therapeutic use)
  • Heparin (adverse effects, pharmacokinetics, therapeutic use)
  • Hirudin Therapy
  • Hirudins (adverse effects, pharmacokinetics)
  • Humans
  • Infusions, Intravenous
  • Injections, Intravenous
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Patient Selection
  • Prospective Studies
  • Recombinant Proteins (adverse effects, pharmacokinetics, therapeutic use)
  • Thrombophlebitis (drug therapy)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: