Two studies show efficacy of oral ulipristal acetate compared with placebo, leuprolide acetate
WEDNESDAY, Feb. 1 (HealthDay News) -- For women with symptomatic fibroids, a daily dose of 5 or 10 mg oral ulipristal acetate is efficacious for controlling uterine bleeding before surgery, compared with placebo or leuprolide acetate, according to two studies published in the Feb. 2 issue of the New England Journal of Medicine.
Jacques Donnez, M.D., Ph.D., from Cliniques Universitaires Saint-Luc Catholic University of Louvain in Brussels, and colleagues investigated the efficacy and safety of oral ulipristal acetate for treatment of symptomatic fibroids before surgery. Women with symptomatic fibroids, excessive bleeding, and anemia were randomly allocated to receive daily oral ulipristal acetate at 5 mg (96 women) or 10 mg (98 women), or placebo (48 women) for up to 13 weeks. At 13 weeks, uterine bleeding was controlled in 91, 92, and 19 percent of women receiving 5-mg ulipristal acetate, 10-mg ulipristal acetate, and placebo, respectively. The median change in fibroid size was −21, −12, and +3 percent, respectively. The most common adverse effects, headache and breast tenderness, occurred at similar rates in those receiving ulipristal acetate or placebo.
In a second study, Donnez and colleagues compared the efficacy and side-effect profile of ulipristal acetate with leuprolide acetate for treatment of uterine fibroids before surgery. Three hundred seven patients received three months of oral ulipristal acetate (5 or 10 mg) or once-monthly intramuscular leuprolide acetate injections. Uterine bleeding was controlled in 90, 98, and 89 percent of those receiving 5-mg ulipristal acetate, 10-mg ulipristal acetate, and leuprolide acetate, respectively; hot flashes, mild to moderate in severity, occurred in 11, 10, and 40 percent of patients, respectively.
"Both the 5-mg and 10-mg daily doses of ulipristal acetate were noninferior to once-monthly leuprolide acetate in controlling uterine bleeding and were significantly less likely to cause hot flashes," the authors of the second study write.
Several authors from both studies disclosed financial ties to pharmaceutical companies, including PregLem, which funded the studies.
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