title: Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease.
abstract: 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.
authors.affiliation: Department Internal Medicine, Unfallkrankenhaus, Lehrkrankenhaus der Freien Universität Berlin, Berlin, Germany. franz-xaverk@ukb.de
authors.forename: Franz-Xaver
authors.initials: FX
authors.lastname: Kleber
authors.forename: Christian
authors.initials: C
authors.lastname: Witt
authors.forename: Günter
authors.initials: G
authors.lastname: Vogel
authors.forename: Klaus
authors.initials: K
authors.lastname: Koppenhagen
authors.forename: Ulrike
authors.initials: U
authors.lastname: Schomaker
authors.forename: Curt Werner
authors.initials: CW
authors.lastname: Flosbach
mesh_terms: D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D017984:Enoxaparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000150:complications*; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012140:Respiratory Tract Diseases / Q000150:complications*; D013923:Thromboembolism / Q000150:complications / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000150:complications / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D006493:Heparin