Lack of effect of a low-molecular-weight heparin (nadroparin) on mortality in bedridden medical in-patients: a prospective randomised double-blind study
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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.
KeywordsPulmonary Embolism Enoxaparin Deep Venous Thrombosis Medical Patient Relative Risk Reduction
Funding: This study was supported by a grant for Independent Research from Sanofi-Choay.
- 2.THRIFT Consensus Group (1992) Risk of and prophylaxis for venous thromboembolism in hospital patients. BMJ 305:567–572Google Scholar
- 6.Halkin H, Goldberg J, Modan M, Modan B (1982) Reduction of mortality in general medical in-patients by low dose heparin prophylaxis. Ann Intern Med 96:561–565Google Scholar
- 8.Fraisse F, Holzapfel L, Couland JM, Simonneau G, Bedock B, Feissel M, Herbecq P, Pordes R, Poussel JF, Roux L (2000) Nadroparin in the prevention of deep vein thrombosis in acute decompensated COPD. The association of non-university affiliated intensive care specialist physicians of France. Am J Respir Crit Care Med 161:1109–1114PubMedGoogle Scholar
- 13.Chauvenet M, Caulin C. Les exigences pour une AMM européenne d’un médicament de la thrombose. In: «Les médicaments de la thrombose. Nouveautés dans l’évaluation et l‘utilisation ». Ed Springer. pp 39–76Google Scholar
- 17.Collignon F, Frydman A, Caplain H et al (1995) Comparison of the pharmacokinetic profiles of three low molecular mass heparins—dalteparin, enoxaparin and nadroparin—administered subcutaneously in healthy volunteers (doses for prevention of thromboembolism). Thromb Haemost 73:630–640PubMedGoogle Scholar
- 18.Mahé I, Drouet L, Chassany O, Grenard AS, Caulin C, Bergmann JF (2002) Low molecular weight heparin for the prevention of deep venous thrombosis: a suitable monitoring in elderly patients? Pathophysiol Haemost Thromb 32:134–136Google Scholar