Ulipristal acetate versus leuprolide acetate for uterine fibroids
| Autor: | Donnez, J, Tomaszewski, J, Vázquez, F, Bouchard, P, Lemieszczuk, B, Baró, F, Nouri, K, Selvaggi, L, Sodowski, K, Bestel, E, Terrill, P, Osterloh, I, Loumaye, E, the PEARL II Study Group, MILANI, RODOLFO |
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| Přispěvatelé: | Donnez, J, Tomaszewski, J, Vázquez, F, Bouchard, P, Lemieszczuk, B, Baró, F, Nouri, K, Selvaggi, L, Sodowski, K, Bestel, E, Terrill, P, Osterloh, I, Loumaye, E, Milani, R, the PEARL II Study, G, Vázquez, F, Baró, F, PEARL II Study Group, PERINO, A |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Adult
medicine.medical_specialty Uterine fibroids Intention to Treat Analysi Urology Administration Oral Endometrium Injections Intramuscular law.invention chemistry.chemical_compound Young Adult Primary outcome Randomized controlled trial Double-Blind Method law Ulipristal acetate Selective progesterone receptor modulator medicine Uterine Neoplasm Ulipristal Menorrhagia Gynecology Intention-to-treat analysis Leiomyoma business.industry Obstetrics and Gynecology Uterine bleeding Uterine fibroids uterine leiomyomas uterine bleeding ulipristal acetate leuprolide acetate medical therapy General Medicine Norpregnadiene Middle Aged medicine.disease Settore MED/40 - Ginecologia E Ostetricia medicine.anatomical_structure chemistry Amenorrhea Female medicine.symptom Leuprolide business Human |
| Popis: | A b s t r ac t Background The 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. Methods In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic 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 intramuscular 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 prespecified noninferiority margin of −20%. Results Uterine 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 percentage 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 acetate. Median times to amenorrhea were 7 days for patients receiving 5 mg of ulipristal 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 |
| Databáze: | OpenAIRE |
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