Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids

Antonino Perino, Francisco Vázquez, Kazem Nouri, Janusz Tomaszewski, Elke Bestel, Paul Terrill, Luigi Selvaggi, Ian Osterloh, Boguslav Lemieszczuk, Krzysztof Sodowski, Francesco Baró, Ernest Loumaye, Jacques Donnez, Philippe Bouchard

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Abstract

BackgroundThe efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear.MethodsIn this double-blind noninferiority trial, we randomly assigned 307 patients with symp- tomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intra- muscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespeci- fied noninferiority margin of −20%.ResultsUterine bleeding was controlled in 90% of patients receiving 5 mg of ulipristal acetate, in 98% of those receiving 10 mg of ulipristal acetate, and in 89% of those receiving leuprolide acetate, for differences (as compared with leuprolide acetate) of 1.2 per- centage points (95% confidence interval [CI], −9.3 to 11.8) for 5 mg of ulipristal acetate and 8.8 percentage points (95% CI, 0.4 to 18.3) for 10 mg of ulipristal ace- tate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulip- ristal acetate, 5 days for those receiving 10 mg of ulipristal acetate, and 21 days for those receiving leuprolide acetate. Moderate-to-severe hot flashes were reported for 11% of patients receiving 5 mg of ulipristal acetate, for 10% of those receiving 10 mg of ulipristal acetate, and for 40% of those receiving leuprolide acetate (P<0.001 for each dose of ulipristal acetate vs. leuprolide acetate).ConclusionsBoth 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.
Lingua originaleEnglish
pagine (da-a)421-432
Numero di pagine12
RivistaNew England Journal of Medicine
Volume366
Stato di pubblicazionePublished - 2012

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All Science Journal Classification (ASJC) codes

  • Medicine(all)

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Perino, A., Vázquez, F., Nouri, K., Tomaszewski, J., Bestel, E., Terrill, P., Selvaggi, L., Osterloh, I., Lemieszczuk, B., Sodowski, K., Baró, F., Loumaye, E., Donnez, J., & Bouchard, P. (2012). Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids. New England Journal of Medicine, 366, 421-432.