A Comparison of Enoxaparin with Placebo for the Prevention of Venous Thromboembolism in Acutely Ill Medical Patients
Meyer Michel Samama, M.D., Alexander Thomas Cohen, M.D., Jean-Yves Darmon, M.D., Louis Desjardins, M.D., Amiram Eldor, M.D., Charles Janbon, M.D., Alain Leizorovicz, M.D., Hélène Nguyen, Pharm.D., Carl-Gustav Olsson, M.D., Ph.D., Alexander Graham Turpie, M.D., Nadine Weisslinger, M.D., for The Prophylaxis in Medical Patients with Enoxaparin Study Group
Background The efficacy and safety of thromboprophylaxis inpatients with acute medical illnesses who may be at risk forvenous thromboembolism have not been determined in adequatelydesigned trials.
Methods In a double-blind study, we randomly assigned 1102 hospitalizedpatients older than 40 years to receive 40 mg of enoxaparin,20 mg of enoxaparin, or placebo subcutaneously once daily for6 to 14 days. Most patients were not in an intensive care unit.The primary outcome was venous thromboembolism between days1 and 14, defined as deep-vein thrombosis detected by bilateralvenography (or duplex ultrasonography) between days 6 and 14(or earlier if clinically indicated) or documented pulmonaryembolism. The duration of follow-up was three months.
Results The primary outcome could be assessed in 866 patients.The incidence of venous thromboembolism was significantly lowerin the group that received 40 mg of enoxaparin (5.5 percent[16 of 291 patients]) than in the group that received placebo(14.9 percent [43 of 288 patients]) (relative risk, 0.37; 97.6percent confidence interval, 0.22 to 0.63; P< 0.001). Thebenefit observed with 40 mg of enoxaparin was maintained atthree months. There was no significant difference in the incidenceof venous thromboembolism between the group that received 20mg of enoxaparin (15.0 percent [43 of 287 patients]) and theplacebo group. The incidence of adverse effects did not differsignificantly between the placebo group and either enoxaparingroup. By day 110, 50 patients in the placebo group had died(13.9 percent), 51 in the 20-mg group had died (14.7 percent),and 41 in the 40-mg group had died (11.4 percent); the differenceswere not significant.
Conclusions Prophylactic treatment with 40 mg per day of enoxaparinsubcutaneously safely reduces the risk of venous thromboembolismin patients with acute medical illnesses.
Source Information
From the Département d'Hématologie Biologique, Hôtel Dieu, Paris (M.M.S.); the Department of Academic Medicine, Guy's, King's, and St. Thomas' School of Medicine, London (A.T.C.); the Département Cardiovasculaire, Laboratoires Rhône–Poulenc Rorer, Montrouge, France (J.-Y.D., H.N., N.W.); the Service d'Hématologie, Centre Hospitalier Universitaire de Québec, Quebec, Canada (L.D.); the Institute of Hematology, Sourasky Medical Center, Ichilov Hospital, Tel Aviv, Israel (A.E.); the Service de Médecine Interne, Centre Hospitalier Universitaire Hôpital Saint-Eloi, Montpellier, France (C.J.); the Service de Pharmacologie Clinique, University of Lyons, Lyons, France (A.L.); the Department of Internal Medicine, University Hospital of Lund, Lund, Sweden (C.-G.O.); and the Department of Medicine, Hamilton Health Sciences Corporation General Division, Hamilton, Ont., Canada (A.G.T.).
Address reprint requests to Dr. Samama at the Département d'Hématologie Biologique, Hôtel Dieu, 1 Pl. du Parvis Notre Dame, 75181 Paris CEDEX 04, France.
Enoxaparin for the Prevention of Venous Thromboembolism
Sosis M. B., Hynson J. M., Calderon E. J., Varela J. M., de la Puente M. A. G., Samama M. M., Cohen A. T., Leizorovicz A., The Prophylaxis in Medical Patients with Enoxaparin Study Group
Extract |
Full Text
N Engl J Med 2000;
342:136-137, Jan 13, 2000.
Correspondence
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