PMID- 10823256
OWN - NLM
STAT- MEDLINE
DCOM- 20000905
LR  - 20171116
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 83
IP  - 5
DP  - 2000 May
TI  - Fixed-dose, body weight-independent subcutaneous LMW heparin versus adjusted dose 
      unfractionated intravenous heparin in the initial treatment of proximal venous 
      thrombosis. EASTERN Investigators.
PG  - 652-6
AB  - BACKGROUND: Body weight-adjusted subcutaneous low-molecular-weight heparin (LMWH) 
      has been proven to be at least as effective and safe as dose-adjusted intravenous 
      unfractionated heparin (UFH) for the treatment of patients with venous 
      thromboembolism. However, body weight-adjusted dosage of low-molecular-weight 
      heparin may be cumbersome and could lead possibly to incorrect dosing. Therefore 
      a fixed LMWH dose, independent of body-weight, might rationalize initial 
      treatment for venous thromboembolism. METHODS: Patients with proven proximal 
      deep-vein thrombosis were randomly assigned to fixed dose subcutaneous LMWH 
      Certoparin (8,000 anti-factor Xa U b.i.d.; 265 patients) or to adjusted dose i.v. 
      UFH (273 patients) for 12 days. Vitamin K antagonists were started between day 3 
      and 7 and continued for up to 6 months. The primary outcome measure was a 30 
      percent or greater improvement in the Marder Score, as revealed by repeated 
      venography on day 12 (end of the initial treatment). The secondary composite 
      outcome measure included death, recurrent venous thromboembolism and major 
      bleeding and was assessed at day 12 and after 6 months by a blinded adjunction 
      committee. RESULTS: The Marder score improved by 30% or more in 30.3% and 25.0% 
      of patients assigned to LMWH (198 paired venograms) and UFH (192 paired 
      venograms), respectively (2p = 0.26). At the end of the initial treatment, the 
      composite outcome was observed in 4 of the 265 patients (1.5%) randomized to 
      LMWH, as compared with 14 of the 273 patients (5.1%) randomized to UFH (2p = 
      0.03). At 6 months these figures were 6.8% and 12.8%, respectively (risk 
      reduction 0.53, confidence interval 0.31-0.90, 2p = 0.02). CONCLUSION: Fixed dose 
      subcutaneous LMWH certoparin is at least as efficacious as UFH in resolving 
      proximal vein thrombosis.
FAU - Harenberg, J
AU  - Harenberg J
AD  - Dept. of Medicine, University Hospital, Mannheim, Germany. 
      J-Harenberg@t-online.de
FAU - Schmidt, J A
AU  - Schmidt JA
FAU - Koppenhagen, K
AU  - Koppenhagen K
FAU - Tolle, A
AU  - Tolle A
FAU - Huisman, M V
AU  - Huisman MV
FAU - Buller, H R
AU  - Buller HR
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Thromb Haemost
JT  - Thrombosis and haemostasis
JID - 7608063
RN  - 0 (Anticoagulants)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 12001-79-5 (Vitamin K)
RN  - 9005-49-6 (Heparin)
RN  - V72OT3K19I (certoparin)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Aged
MH  - Anticoagulants/*administration & dosage/adverse effects/therapeutic use
MH  - Body Weight
MH  - Cohort Studies
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  - Phlebography
MH  - Popliteal Vein
MH  - Postoperative Complications/diagnostic imaging/drug therapy/mortality
MH  - Recurrence
MH  - Treatment Outcome
MH  - Venous Thrombosis/diagnostic imaging/*drug therapy/mortality
MH  - Vitamin K/antagonists & inhibitors
EDAT- 2000/05/24 09:00
MHDA- 2000/09/09 11:01
CRDT- 2000/05/24 09:00
PHST- 2000/05/24 09:00 [pubmed]
PHST- 2000/09/09 11:01 [medline]
PHST- 2000/05/24 09:00 [entrez]
AID - 00050652 [pii]
PST - ppublish
SO  - Thromb Haemost. 2000 May;83(5):652-6.