|Title: ||Fondaparinux for the treatment of superficial vein thrombosis in the legs|
|Authors: ||Decousus, Herve|
Vaquero Puerta, Carlos
Bauersachs, Rupert M.
Calixto Study Group
|Issue Date: ||2010|
|Publisher: ||Massachussetts Medical Society|
|Description: ||Producción Científica|
|Citation: ||New England Journal of Medicine, Sept. 2010 p.363-373|
|Abstract: ||The efficacy and safety of anticoagulant treatment for patients with acute, symptom- atic superf
icial-vein thrombosis in the legs, but without concomitant deep-vein thrombosis or symptomatic
pulmonary embolism at presentation, have not been es- tablished.
In a randomized, double-blind trial, we assigned 3002 patients to receive either fonda- parinux,
administered subcutaneously at a dose of 2.5 mg once daily, or placebo for
45 days. The primary eff icacy outcome was a composite of death from any cause or symptomatic
pulmonary embolism, symptomatic deep-vein thrombosis, or symp- tomatic extension to the
saphenofemoral junction or symptomatic recurrence of superf icial-vein thrombosis at day 47. The
main safety outcome was major bleeding. The patients were followed until day 77.
The primary eff icacy outcome occurred in 13 of 1502 patients (0.9%) in the fonda- parinux group
and 88 of 1500 patients (5.9%) in the placebo group (relative risk reduction with fondaparinux,
85%; 95% conf idence interval [CI], 74 to 92; P<0.001). The incidence of each component of the
primary efficacy outcome was significantly reduced in the fondaparinux group as compared with the
placebo group, except for the outcome of death (0.1% in both groups). The rate of pulmonary
embolism or deep-vein thrombosis was 85% lower in the fondaparinux group than in the pla- cebo
group (0.2% vs. 1.3%; 95% CI, 50 to 95; P<0.001). Similar risk reductions were observed at day 77.
A total of 88 patients would need to be treated to prevent one instance of pulmonary embolism or
deep-vein thrombosis. Major bleeding occurred in one patient in each group. The incidence of
serious adverse events was 0.7% with fondaparinux and 1.1% with placebo.
Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treat- ment of
patients with acute, symptomatic superf icial-vein thrombosis of the legs and did not have serious
side effects. (Funded by GlaxoSmithKline; ClinicalTrials
.gov number, NCT00443053.)|
|Keywords: ||Trombosis-Atención médica|
|Peer Review: ||SI|
|Rights Owner: ||Massachusset Study Group|
|Appears in Collections:||DEP11 - Artículos de revista|