PMID- 14555312
OWN - NLM
STAT- MEDLINE
DCOM- 20040930
LR  - 20171116
IS  - 1592-8721 (Electronic)
IS  - 0390-6078 (Linking)
VI  - 88
IP  - 10
DP  - 2003 Oct
TI  - Comparison of six-month outcome of patients initially treated for acute deep vein 
      thrombosis with a low molecular weight heparin Certoparin at a fixed, 
      body-weight-independent dosage or unfractionated heparin.
PG  - 1157-62
AB  - BACKGROUND AND OBJECTIVES: Body weight-adjusted subcutaneous low molecular weight 
      heparin (LMWH) has been proven to be more effective and safer than aPTT-adjusted 
      intravenous unfractionated heparin (UFH) for the initial treatment of patients 
      with acute symptomatic deep venous thrombosis (DVT) based on analyses pooling the 
      results of studies with different LMWHs. We investigated whether these findings 
      hold for a particular LMWH by pooling the results of two independent studies. 
      DESIGN AND METHODS: Patients with acute symptomatic proximal DVT (n=1758), proven 
      by ascending phlebography or compression ultrasound, received either a fixed, 
      body weight independent dose of 8,000 IU Certoparin b.i.d. (n=893) for 8.6 days 
      or intravenous UFH (n=865) adjusted to an 1.5 to 3.0-fold prolongation of the 
      aPTT for 12.0 days both followed by vitamin K-antagonists for 6 months. RESULTS: 
      Venous thromboembolism (VTE) re-occurred in 5.1% and 3.1% (RRR 0.62, CI 
      0.39-0.98, 2p=0.04), major bleeding in 3.5% and 1.9% (RRR 0.55, CI 0.31-0.99, 
      2p=0.05), mortality in 3.6% and 2.1% (RRR 0.59, CI 0.34-1.04, 2p=0.08), and the 
      composite outcome of all three events in 10.3% and 6.3% (RRR 0.61, CI 0.44 to 
      0.84, 2p=0.002) of patients at 6 months initially randomised to UFH and LMWH, 
      respectively. INTERPRETATION AND CONCLUSIONS: The initial treatment of acute DVT 
      with a fixed dose of the LMWH, certoparin, is more effective in reducing, over 6 
      months, the re-occurrence of VTE and the composite outcome of recurrent VTE, 
      major bleeding, and mortality without any relation of the bodyweight of the 
      patients to recurrent venous thromboembolism or major bleeding complications.
FAU - Harenberg, Job
AU  - Harenberg J
AD  - IV. Dept. of Medicine, University Hospital, Mannheim, Ruprecht-Karls University 
      Heidelberg, Mannheim, Germany. j-harenberg@t-online.de
FAU - Riess, Hanno
AU  - Riess H
FAU - Buller, Harry R
AU  - Buller HR
FAU - Brom, Joachim
AU  - Brom J
FAU - Weidinger, Gottfried
AU  - Weidinger G
FAU - Huisman, Menno V
AU  - Huisman MV
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - Italy
TA  - Haematologica
JT  - Haematologica
JID - 0417435
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
MH  - Anticoagulants/administration & dosage/adverse effects/therapeutic use
MH  - Body Weight/*physiology
MH  - Drug Administration Schedule
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/*administration & dosage/adverse effects/*therapeutic use
MH  - Heparin, Low-Molecular-Weight/*administration & dosage/adverse 
      effects/*therapeutic use
MH  - Humans
MH  - Injections, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Venous Thrombosis/*drug therapy/mortality
EDAT- 2003/10/14 05:00
MHDA- 2004/10/01 05:00
CRDT- 2003/10/14 05:00
PHST- 2003/10/14 05:00 [pubmed]
PHST- 2004/10/01 05:00 [medline]
PHST- 2003/10/14 05:00 [entrez]
PST - ppublish
SO  - Haematologica. 2003 Oct;88(10):1157-62.