Fondaparinux Effective in Superficial-Vein Thrombosis
May reduce risk of subsequent deep-vein thrombosis, pulmonary embolism
WEDNESDAY, Sept. 22 (HealthDay News) -- Fondaparinux appears to be safe and effective for reducing symptomatic superficial-vein thrombosis of the legs and may reduce the risk of that condition progressing to deep-vein thrombosis or pulmonary embolism, according to the results of a large randomized trial published in the Sept. 23 issue of the New England Journal of Medicine.
Hervé Decousus, M.D., of the Hôpital Nord in Saint-Etienne, France, and colleagues randomly assigned 3,002 patients to fondaparinux or placebo to study the efficacy and safety of the drug as an anticoagulant treatment for acute, symptomatic superficial-vein thrombosis.
The primary efficacy outcome -- a composite of all-cause death or symptomatic pulmonary embolism, symptomatic deep-vein thrombosis, or symptomatic extension to the saphenofemoral junction or symptomatic recurrence of superficial-vein thrombosis at day 47 -- occurred in 0.9 percent of the 1,502 patients in the treatment arm and 5.9 percent of the 1,500 placebo recipients. Death occurred in 0.1 percent in both groups, but pulmonary embolism or deep-vein thrombosis occurred at an 85-percent lower rate in the treatment arm. Serious adverse events occurred in 0.7 percent of the treatment arm and 1.1 percent of the placebo arm.
"Fondaparinux at a dose of 2.5 mg once a day for 45 days was effective in the treatment of patients with acute, symptomatic superficial-vein thrombosis of the legs and did not have serious side effects," the authors write.
The trial was funded by GlaxoSmithKline; several authors disclosed financial relationships with pharmaceutical companies, including GlaxoSmithKline.