Ulipristal Acetate versus Leuprolide Acetate

for Uterine Fibroids

Jacques Donnez, M.D., Ph.D., Janusz Tomaszewski, M.D., Ph.D.,

Francisco V®¢zquez, M.D., Ph.D., Philippe Bouchard, M.D.,

Boguslav Lemieszczuk, M.D., Francesco Bar®Æ, M.D., Ph.D., Kazem Nouri, M.D.,

Luigi Selvaggi, M.D., Krzysztof Sodowski, M.D., Elke Bestel, M.D.,

Paul Terrill, Ph.D., Ian Osterloh, M.R.C.P., and Ernest Loumaye, M.D., Ph.D.,

for the PEARL II Study Group*

Summary:

                          In this article, the authors assess the efficacy of Ulipristal acetate in the treatment of Uterine Leiomyomas compared to Leuprolide Acetate. This study was conducted as a double blind noninferiority trial in which 307 patients that had symptomatic fibroids and excessive uterine bleeding. These patients were randomly assigned and given 3 months of daily therapy of ulipristal PO 5 mg or 10 mg or one-time IM injection of leuprolide acetate 3.75 mg. By doing constructing this study this way, the authors hoped to assess their primary outcome which was to see the proportion of patients that had controlled bleeding by week 13. The results of this study showed that 90% of the patients that received 5mg of ulipristal acetate had their bleeding controlled while 98% of the 10 mg group of ulipristal had their bleeding controlled. This was opposed to the leuprolide group which only had 89% of these patients with controlled bleeding. Additionally, the authors observed the side effects these medications had on the patients. It was found that in the 5 mg and the 10 mg ulipristal acetate groups 11% and 10% of the patients, respectively, reported moderate to severe hot flashes. This side effect profile was much more appealing than side effect prolife reported in the leuprolide acetate group, in which 40% of the patients complained of moderate to severe hot flashes. Both the controlled bleeding and the side effect profiles proved that both 5 mg and the 10 mg daily doses of ulipristal acetate were noninferior to the leuprolide injections. This is a significant study which allows practitioners to present both options to patients and allowing them to weight pros and cons of both medications before deciding which one they would like to take.

Leiomyoma study - site eval