PMID- 12679756
OWN - NLM
STAT- MEDLINE
DCOM- 20030501
LR  - 20220409
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 145
IP  - 4
DP  - 2003 Apr
TI  - Randomized comparison of enoxaparin with unfractionated heparin for the 
      prevention of venous thromboembolism in medical patients with heart failure or 
      severe respiratory disease.
PG  - 614-21
AB  - BACKGROUND: We compared the efficacy and safety of the low-molecular weight 
      heparin enoxaparin with unfractionated heparin (UFH) for the prevention of venous 
      thromboembolic disease in patients with heart failure or severe respiratory 
      disease. METHODS: This was a multicenter, controlled, randomized, open study in 
      which patients received either enoxaparin (40 mg once daily) or UFH (5000 IU 3 
      times daily) for 10 +/- 2 days in 64 medical departments in Germany. Patients 
      were stratified and enrolled according to their underlying disease: severe 
      respiratory disease or heart failure. The primary efficacy parameter was a 
      thromboembolic event up to 1 day after the treatment period. RESULTS: Of the 665 
      patients enrolled, 451 patients were able to be evaluated in the primary efficacy 
      analysis. The incidence of thromboembolic events was 8.4% with enoxaparin and 
      10.4% with UFH. Enoxaparin was at least as effective as UFH, with a 1-sided 
      equivalence region of -4% (90% CI -2.5-6.5, P =.015). Enoxaparin was associated 
      with fewer deaths, less bleeding, and significantly fewer adverse events (45.8% 
      vs 53.8%, P =.044). CONCLUSIONS: Enoxaparin is at least as effective as UFH in 
      the prevention of thromboembolic events in patients with heart failure or severe 
      respiratory disease. Its beneficial safety profile and once-daily administration 
      is advantageous for inpatient and outpatient use.
FAU - Kleber, Franz-Xaver
AU  - Kleber FX
AD  - Department Internal Medicine, Unfallkrankenhaus, Lehrkrankenhaus der Freien 
      Universitat Berlin, Berlin, Germany. franz-xaverk@ukb.de
FAU - Witt, Christian
AU  - Witt C
FAU - Vogel, Gunter
AU  - Vogel G
FAU - Koppenhagen, Klaus
AU  - Koppenhagen K
FAU - Schomaker, Ulrike
AU  - Schomaker U
FAU - Flosbach, Curt Werner
AU  - Flosbach CW
CN  - THE-PRINCE Study Group
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Anticoagulants)
RN  - 0 (Enoxaparin)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Aged
MH  - Anticoagulants/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Administration Schedule
MH  - Enoxaparin/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Heart Failure/*complications
MH  - Hemorrhage/chemically induced
MH  - Heparin/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Respiratory Tract Diseases/*complications
MH  - Thromboembolism/complications/*prevention & control
MH  - Venous Thrombosis/complications/*prevention & control
EDAT- 2003/04/08 05:00
MHDA- 2003/05/02 05:00
CRDT- 2003/04/08 05:00
PHST- 2003/04/08 05:00 [pubmed]
PHST- 2003/05/02 05:00 [medline]
PHST- 2003/04/08 05:00 [entrez]
AID - S000287030300070X [pii]
AID - 10.1067/mhj.2003.189 [doi]
PST - ppublish
SO  - Am Heart J. 2003 Apr;145(4):614-21. doi: 10.1067/mhj.2003.189.