Fondaparinux feasible for superficial-vein thrombosis in the legs
MedWire News: The anticoagulant fondaparinux can be used to effectively treat superficial-vein thrombosis of the leg, results of a multinational study have shown.
Hervé Decousus (Hôpital Nord, Saint-Etienne, France) and colleagues carried out the study, which included 3002 patients from 171 centers in 17 countries, to identify a well-defined treatment for patients with superficial-vein thrombosis of the leg.
Patients with acute, symptomatic superficial-vein thrombosis in the legs, but without concomitant deep vein thrombosis (DVT) or symptomatic pulmonary embolism (PE), were randomly assigned to receive either fondaparinux, administered subcutaneously at a dose of 2.5 mg once daily (n=1502), or placebo (n=1500) for 45 days.
The researchers then assessed the patients at day 47 and day 77 for the composite outcome of death from any cause, or symptomatic PE, symptomatic DVT, symptomatic extension to the saphenofemoral junction, or symptomatic recurrence of superficial-vein thrombosis.
Decousus and team report that the composite outcome occurred in 13 (0.9%) patients in the fondaparinux group and 88 (5.9%) patients in the placebo group at day 47, which was equivalent to an 85% reduction in the risk for symptomatic thromboembolic complications or death. Similar results were observed at day 77.
The rate of PE or DVT was also 85% lower in the fondaparinux group than in the placebo group (0.2% vs 1.3%), but the mortality rate did not vary between the groups (0.1% vs 0.1%).
In addition, significantly more patients in the placebo group than in the fondaparinux group had undergone surgery for superficial-vein thrombosis by day 77 (4.1% vs 1.0%).
One patient in each group suffered major bleeding and the incidence of serious adverse events did not differ between the groups, at 0.7% for fondaparinux and 1.1% for placebo.
Superficial-vein thrombosis of the leg is a common condition that puts patients at risk for subsequent symptomatic venous thromboembolic complications, remark Decousus and co-authors in the New England Journal of Medicine. "Fondaparinux administered at a dose of 2.5 mg once daily for 45 days is effective and widely applicable for the treatment of such patients," they conclude.
In an accompanying editorial, Lee Goldman (Columbia University, New York, USA) and Jeffrey Ginsberg (McMaster University, Hamilton, Ontario, Canada) point out that in this study, about 88 patients needed to be treated with fondaparinux to prevent one nonfatal episode of DVT or PE.
They calculated that the net cost of fondaparinux treatment for 1500 patients would be approximately US$2.88 million, or US$1,900 per treated patient, without any lives saved.
So until cost-effectiveness data are available, "it would seem premature to recommend that fondaparinux be used routinely in the treatment of superficial-vein thrombosis," Goldman and Ginsberg write.
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By Laura Dean