PMID- 8902991
OWN - NLM
STAT- MEDLINE
DCOM- 19970311
LR  - 20220409
IS  - 0340-6245 (Print)
IS  - 0340-6245 (Linking)
VI  - 76
IP  - 4
DP  - 1996 Oct
TI  - A multicenter randomized double-blind study of enoxaparin compared with 
      unfractionated heparin in the prevention of venous thromboembolic disease in 
      elderly in-patients bedridden for an acute medical illness. The Enoxaparin in 
      Medicine Study Group.
PG  - 529-34
AB  - A multicenter, randomized double-blind study compared in two parallel groups the 
      efficacy and safety of a low molecular weight heparin (LMWH) enoxaparin 20 mg 
      once daily, with unfractionated heparin (UFH) 5000 IU twice daily, administered 
      subcutaneously for 10 days, in the prevention of venous thrombosis disease in 442 
      hospitalized elderly patients bedridden for an acute medical illness. The main 
      efficacy endpoint was defined as the occurrence of venous thrombosis, diagnosed 
      by a daily fibrinogen uptake test, and/or documented clinical pulmonary embolism. 
      Intention-to-treat analysis of efficacy showed that the incidence of venous 
      thromboembolic events was low: 4.8% (10/207) in the LMWH group (9 episodes of 
      isotopic venous thrombosis and one of scintigraphic pulmonary embolism), and 4.6% 
      (10/216) in the UFH group (10 episodes of isotopic venous thrombosis). The two 
      treatments were equivalent, where equivalence was defined as a maximum difference 
      of 7% between the two groups (p = 0.0005). There were no significant differences 
      in terms of safety between the 216 patients in the LMWH group and the 223 
      patients in the UFH group who received at least one injection of the randomized 
      treatment. During the study period, 15 patients (3.4%) died (7 in the LMWH group 
      and 8 in the UFH group): 2 sudden deaths, one in each group including one case in 
      which pulmonary embolism could not be excluded since no autopsy was performed, 
      and 13 others deaths unrelated to the study treatments. Six patients (1.4%) 
      presented a bleeding complication: 2 (0.9%) in the enoxaparin group (one major 
      and one minor hemorrhage), and 4 (1.8%) in the UFH group (2 major and 2 minor 
      hemorrhages). These results indicate that subcutaneous enoxaparin 20 mg once 
      daily for 10 days is as effective and well tolerated as subcutaneous UFH 5000 IU 
      twice daily in the prevention of venous thromboembolic disease in bedridden 
      elderly in-patients presenting an acute medical illness.
FAU - Bergmann, J F
AU  - Bergmann JF
AD  - Clinique therapeutique, Hopital Lariboisiere, Paris, France.
FAU - Neuhart, E
AU  - Neuhart E
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 (Enoxaparin)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Acute Disease
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Chi-Square Distribution
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Enoxaparin/adverse effects/*therapeutic use
MH  - Female
MH  - Heparin/adverse effects/*therapeutic use
MH  - Hospitals
MH  - Humans
MH  - Immobilization
MH  - Injections, Subcutaneous
MH  - Male
MH  - Pulmonary Embolism/mortality/*prevention & control
MH  - Thrombophlebitis/mortality/*prevention & control
MH  - Treatment Outcome
EDAT- 1996/10/01 00:00
MHDA- 1996/10/01 00:01
CRDT- 1996/10/01 00:00
PHST- 1996/10/01 00:00 [pubmed]
PHST- 1996/10/01 00:01 [medline]
PHST- 1996/10/01 00:00 [entrez]
PST - ppublish
SO  - Thromb Haemost. 1996 Oct;76(4):529-34.