Enoxaparin and prevention of venous thrombo-embolism in medical units: new indication. No tangible benefit.
(1) In France, enoxaparin 40 mg has been granted a license extension to cover the prevention of deep vein thrombosis in patients confined to bed for acute medical reasons and who have at least one other risk factor. (2) In this indication the clinical file is based on one placebo-controlled trial with methodological weaknesses, such as the use of a surrogate end point (phlebography) and exclusion of a large number of patients from analysis. (3) In this trial fewer than 1% of the 1 102 patients enrolled had a clinical venous thrombosis in the placebo group. Enoxaparin was no more effective than the placebo on clinical outcome measures. (4) Massive bruising at the injection site was more common on enoxaparin than on the placebo. (5) Two trials versus unfractionated heparin, one of which involved nearly 1 000 patients, also failed to show any superiority of enoxaparin over placebo. (6) The cost of enoxaparin in this indication is unjustified, given the lack of proven benefit.
D000925:Anticoagulants / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D017277:Drug Approval; D017984:Enoxaparin / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D005602:France; D006801:Humans; D013923:Thromboembolism / Q000188:drug therapy*; D016896:Treatment Outcome
D000925:Anticoagulants; D017984:Enoxaparin; D005343:Fibrinolytic Agents