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001-es BibID:	BIBFORM013825
Első szerző:	Decousus, Hervé
Cím:	Fondaparinux for the Treatment of Superficial-Vein Thrombosis in the Legs / Hervé Decousus, Paolo Prandoni, Patrick Mismetti, Rupert M. Bauersachs, Zoltán Boda, Benjamin Brenner, Silvy Laporte, Lajos Matyas, Saskia Middeldorp, German Sokurenko, Alain Leizorovicz, The CALISTO Study Group
Dátum:	2010
Megjegyzések:	The efficacy and safety of anticoagulant treatment for patients with acute, symptomaticsuperficial-vein thrombosis in the legs, but without concomitant deep-veinthrombosis or symptomatic pulmonary embolism at presentation, have not been established.MethodsIn a randomized, double-blind trial, we assigned 3002 patients to receive either fondaparinux,administered subcutaneously at a dose of 2.5 mg once daily, or placebo for45 days. The primary efficacy outcome was a composite of death from any cause orsymptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomaticextension to the saphenofemoral junction or symptomatic recurrence ofsuperficial-vein thrombosis at day 47. The main safety outcome was major bleeding.The patients were followed until day 77.ResultsThe primary efficacy outcome occurred in 13 of 1502 patients (0.9%) in the fondaparinuxgroup and 88 of 1500 patients (5.9%) in the placebo group (relative riskreduction with fondaparinux, 85%; 95% confidence interval [CI], 74 to 92; P<0.001).The incidence of each component of the primary efficacy outcome was significantlyreduced in the fondaparinux group as compared with the placebo group, except forthe outcome of death (0.1% in both groups). The rate of pulmonary embolism ordeep-vein thrombosis was 85% lower in the fondaparinux group than in the placebogroup (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions wereobserved at day 77. A total of 88 patients would need to be treated to prevent oneinstance of pulmonary embolism or deep-vein thrombosis. Major bleeding occurredin one patient in each group. The incidence of serious adverse events was 0.7% withfondaparinux and 1.1% with placebo.ConclusionsFondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatmentof patients with acute, symptomatic superficial-vein thrombosis of the legsand did not have serious side effects.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	The New England Journal of Medicine. - 363 : 13 (2010), p. 1222-1232. -
További szerzők:	Prandoni, Paolo Mismetti, Patrick Bauersachs, Rupert M. Boda Zoltán (1947-) (belgyógyász, haematologus, klinikai onkológus) Brenner, Benjamin Laporte, Silvy Mátyás Lajos Middeldorp, Saskia Sokurenko, German Leizorovicz, Alain The CALISTO Study Group
Internet cím:	Intézményi repozitóriumban (DEA) tárolt változat DOI elektronikus változat
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