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Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients

Leizorovicz, A.; Cohen, A.T.; Turpie, A. G. G.; Olsson, Carl-Gustav LU ; Vaitkus, P. T.; Goldhaber, S. Z. and Stu, Prevent Med Thromboprophylaxis (2004) In Circulation 110(7). p.874-879
Abstract
Background-Considerable variability exists in the use of pharmacological thromboprophylaxis among acutely ill medical patients, partly because clinically relevant end points have not been fully assessed in this population. We undertook an international, multicenter, randomized, double-blind, placebo-controlled trial using clinically important outcomes to assess the efficacy and safety of dalteparin in the prevention of venous thromboembolism in such patients. Methods and Results-Patients (n=3706) were randomly assigned to receive either subcutaneous dalteparin 5000 IU daily or placebo for 14 days and were followed up for 90 days. The primary end point was venous thromboembolism, defined as the combination of symptomatic deep vein... (More)
Background-Considerable variability exists in the use of pharmacological thromboprophylaxis among acutely ill medical patients, partly because clinically relevant end points have not been fully assessed in this population. We undertook an international, multicenter, randomized, double-blind, placebo-controlled trial using clinically important outcomes to assess the efficacy and safety of dalteparin in the prevention of venous thromboembolism in such patients. Methods and Results-Patients (n=3706) were randomly assigned to receive either subcutaneous dalteparin 5000 IU daily or placebo for 14 days and were followed up for 90 days. The primary end point was venous thromboembolism, defined as the combination of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, and asymptomatic proximal deep vein thrombosis detected by compression ultrasound at day 21 and sudden death by day 21. The incidence of venous thromboembolism was reduced from 4.96% (73 of 1473 patients) in the placebo group to 2.77% (42 of 1518 patients) in the dalteparin group, an absolute risk reduction of 2.19% or a relative risk reduction of 45% (relative risk, 0.55; 95% CI, 0.38 to 0.80; P=0.0015). The observed benefit was maintained at 90 days. The overall incidence of major bleeding was low but higher in the dalteparin group (9 patients; 0.49%) compared with the placebo group (3 patients; 0.16%). Conclusions-Dalteparin 5000 IU once daily halved the rate of venous thromboembolism with a low risk of bleeding. (Less)
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organization
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type
Contribution to journal
publication status
published
subject
keywords
DEEP-VEIN THROMBOSIS, ACUTE PULMONARY-EMBOLISM, anticoagulants, prevention, thrombosis, CARE, PROPHYLAXIS, DIAGNOSIS, PATHOPHYSIOLOGY, REGISTRY, EFFICACY, embolism, CLINICAL-PRACTICE, heparin
in
Circulation
volume
110
issue
7
pages
874 - 879
publisher
Lippincott Williams and Wilkins
external identifiers
  • wos:000223331600018
  • scopus:4143085802
ISSN
1524-4539
DOI
10.1161/01.cir.0000138928.83266.24
language
English
LU publication?
yes
id
9c0b889c-75bd-4047-9313-3d7907b51923 (old id 1417196)
date added to LUP
2009-06-16 16:50:52
date last changed
2017-12-10 04:25:02
@article{9c0b889c-75bd-4047-9313-3d7907b51923,
  abstract     = {Background-Considerable variability exists in the use of pharmacological thromboprophylaxis among acutely ill medical patients, partly because clinically relevant end points have not been fully assessed in this population. We undertook an international, multicenter, randomized, double-blind, placebo-controlled trial using clinically important outcomes to assess the efficacy and safety of dalteparin in the prevention of venous thromboembolism in such patients. Methods and Results-Patients (n=3706) were randomly assigned to receive either subcutaneous dalteparin 5000 IU daily or placebo for 14 days and were followed up for 90 days. The primary end point was venous thromboembolism, defined as the combination of symptomatic deep vein thrombosis, symptomatic pulmonary embolism, and asymptomatic proximal deep vein thrombosis detected by compression ultrasound at day 21 and sudden death by day 21. The incidence of venous thromboembolism was reduced from 4.96% (73 of 1473 patients) in the placebo group to 2.77% (42 of 1518 patients) in the dalteparin group, an absolute risk reduction of 2.19% or a relative risk reduction of 45% (relative risk, 0.55; 95% CI, 0.38 to 0.80; P=0.0015). The observed benefit was maintained at 90 days. The overall incidence of major bleeding was low but higher in the dalteparin group (9 patients; 0.49%) compared with the placebo group (3 patients; 0.16%). Conclusions-Dalteparin 5000 IU once daily halved the rate of venous thromboembolism with a low risk of bleeding.},
  author       = {Leizorovicz, A. and Cohen, A.T. and Turpie, A. G. G. and Olsson, Carl-Gustav and Vaitkus, P. T. and Goldhaber, S. Z. and Stu, Prevent Med Thromboprophylaxis},
  issn         = {1524-4539},
  keyword      = {DEEP-VEIN THROMBOSIS,ACUTE PULMONARY-EMBOLISM,anticoagulants,prevention,thrombosis,CARE,PROPHYLAXIS,DIAGNOSIS,PATHOPHYSIOLOGY,REGISTRY,EFFICACY,embolism,CLINICAL-PRACTICE,heparin},
  language     = {eng},
  number       = {7},
  pages        = {874--879},
  publisher    = {Lippincott Williams and Wilkins},
  series       = {Circulation},
  title        = {Randomized, placebo-controlled trial of dalteparin for the prevention of venous thromboembolism in acutely ill medical patients},
  url          = {http://dx.doi.org/10.1161/01.cir.0000138928.83266.24},
  volume       = {110},
  year         = {2004},
}