Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: A prospective randomised double-blind study

Service Médecine A, AP-HP, Hôpital Lariboisière, 2, rue Ambroise Paré, 75010, Paris, France.
European Journal of Clinical Pharmacology (Impact Factor: 2.7). 08/2005; 61(5-6):347-51. DOI: 10.1007/s00228-005-0944-3
Source: PubMed

ABSTRACT 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.
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.
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].
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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    • "In comparison to placebo, nadroparin failed to reduce the incidence of thromboembolic episodes, as well as the rate of mortality. The result reported by Mahe et al (2005) was in contrast with that of Gardlund (1996), who found a reduction in total mortality in patients hospitalized with an infectious disease. A meta-analysis of randomized trials addressed the value of prophylaxis with UFH or low molecular weight heparin (LMWH) in internal medicine (Mismetti et al, 2000). "
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