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.
|
Authors | F 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 |
Journal | Thrombosis and haemostasis
(Thromb Haemost)
Vol. 77
Issue 5
Pg. 834-8
(May 1997)
ISSN: 0340-6245 [Print] Germany |
PMID | 9184388
(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)
|