Abstract | BACKGROUND: Hospitalised medical patients are at significant risk of venous thromboembolic disease through fatal pulmonary embolism; low-molecular-weight heparins have been proved efficient in preventing deep venous thrombosis in surgical and medical patients, but their effect on mortality in bedridden medical patients remains unknown. METHODS: In a multi-centre, randomised, double-blind, placebo-controlled study, 2,474 consecutive patients aged over 40 years admitted to internal medicine departments in the last 24 h and unable to move alone were randomised to receive 0.3 ml nadroparin (7,500 anti-Xa units) or placebo for up to 21 days. The primary end-point was overall mortality at day 21. RESULTS: There were no significant differences between the patients' characteristics. Overall mortality between the two groups was not statistically different [10.08% (124 of 1,230) versus 10.29% (128 of 1,244), respectively, in the nadroparin and in the placebo groups; relative risk reduction 0.02, CI (-0.27, +0.25), P=0.89]. An autopsy was performed in 123 of the 252 patients who died (49%). Pulmonary embolism was discovered at autopsy in 10 of 63 patients in the nadroparin group and in 17 of 60 in the placebo group [relative risk reduction 0.38, CI (-0.27, +0.70), P=0.13]. CONCLUSION:
Nadroparin does not have a significant effect on mortality in bedridden medical patients, based on the study results. The study provides no data suggesting that low-molecular-weight heparins might reduce the incidence of thromboembolic in-patients hospitalised for an acute medical disease.
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Authors | I Mahé, J F Bergmann, P d'Azémar, J J Vaissie, C Caulin |
Journal | European journal of clinical pharmacology
(Eur J Clin Pharmacol)
Vol. 61
Issue 5-6
Pg. 347-51
(Jul 2005)
ISSN: 0031-6970 [Print] Germany |
PMID | 15981008
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anticoagulants
- Nadroparin
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Topics |
- Acute Disease
- Adult
- Aged
- Aged, 80 and over
- Anticoagulants
(administration & dosage, therapeutic use)
- Autopsy
- Double-Blind Method
- Female
- Hospitals
- Humans
- Incidence
- Male
- Middle Aged
- Nadroparin
(administration & dosage, therapeutic use)
- Prospective Studies
- Pulmonary Embolism
(epidemiology, mortality, prevention & control)
- Survival Analysis
- Thromboembolism
(epidemiology, mortality, prevention & control)
- Venous Thrombosis
(epidemiology, mortality, prevention & control)
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