TRIP

Morning-After Pill Does Double Duty (CME/CE)

MedPageToday, 2012

– is a selective progesterone-receptor modulator, a class of drugs proposed as a possible treatment for fibroids, according to Jacques Donnez, MD, PhD, of the Saint-Luc Catholic University of Louvain in Brussels, and colleagues.
In two randomized controlled trials, the compound outperformed placebo and was noninferior to an established medical therapy for fibroids, leuprolide acetate (Lupron), Donnez and colleagues reported in the Feb.
The studies "represent an important step" toward medical therapy for fibroids, according to Elizabeth Stewart, MD, of the Mayo Clinic in Rochester, Minn.
Advances in interventional therapies in recent years have led to minimally invasive alternatives to hysterectomy, Stewart noted in an accompanying editorial.
"Unfortunately," she argued, "the rate of hysterectomy continues to be high, and there remains substantial need for effective medical therapy."
While leuprolide is effective, it lowers estrogen levels, leading to symptoms such as hot flashes, and also has long-term effects on bone density.
On the other hand, a concern about selective progesterone-receptor modulators has been a potential for endometrial proliferation, possibly leading to hyperplasia or carcinoma, Stewart noted.
The two studies – dubbed PEARL I and II – investigated the effects of ulipristal compared with placebo or leuprolide in women with symptomatic fibroids and excessive uterine bleeding.
In both trials, women intended to have surgery as a definitive treatment for fibroids, and the therapy was intended to reduce bleeding and fibroid volume.
In the placebo-controlled trial, 96 women got 5 mg daily of the drug, 98 got 10 mg a day, and 48 got the matching placebo for up to 13 weeks of therapy.
The primary endpoint was control of bleeding, defined as a score of less than 75 on the pictorial blood-loss assessment chart, and reduction of fibroid volume.