Effect of ulipristal acetate on leomyoma of uterus
DOI:
https://doi.org/10.18203/2320-1770.ijrcog20240773Keywords:
UPA, Leomyoma, UterusAbstract
Background: The efficacy and side-effect profile of ulipristal acetate (UPA) for the treatment of symptomatic uterine fibroids before surgery are unclear. Main objective of the study to see the effect of UPA on leomyoma.
Methods: An observational clinical trial was conducted at the department of gynaecology and obstetrics, Sir Salimullah medical college and Mitford hospital, Dhaka, from January to June 2015. Thirty women aged 18-48 with symptomatic fibroid uterus were studied. They received Tablet UPA 5 mg/day for 3 months. Evaluation included history taking, physical examination, pelvic ultrasonography, and necessary investigations.
Results: The majority of patients (43.3%) were ≤30 years old. Before intervention, heavy bleeding was observed in all patients until the 8th day of menstruation. During intervention, majority had no bleeding from the 5th to 8th day, with only a few experiencing heavy bleeding on the 7th and 8th day. After intervention, most patients had no bleeding from the 5th to 8th day, with a few reporting spotting on the 5th day. Before treatment, 60% had fibroid size >10 cm2. After treatment, 92.3% had fibroid size <10 cm2, with 7.7% showing no fibroids. Mean uterine size decreased post-treatment. Majority (57.7%) had hemoglobin >11 gm/dl. Side effects included headache (11.5%), hot flashes (15.4%), and nausea/vertigo (19.2%). Treatment success rate was 86.7%.
Conclusions: In a group of selected patients with fibroid uterus and heavy menstrual bleeding, UPA (5 mg/day for 3 months) successfully decreases blood loss and shrinks fibroid and uterine size by 86.7%.
References
Donnez J, Tomaszewski J, Vazquez F, Bouchard P, Lemieszczuk B, Baro F. Ulipristal Acetate versus Leuprolide Acetate for Uterine Fibroids. N Engl J Med. 2012;366(5):421-32.
Donnez J, Tatarchuk TF, Bouchard P, Puscasiu L, Zakharenko NF. Ulipristal Acetate versus Placebo for Fibroid Treatment before Surgery. N Engl J Med. 2012;366(5):409-20.
Donnez J, Vazquez F, Tomaszewski J, Nouri K, Bouchard P, Fauser BC, et al. Long-term treatment of uterine fibroids with ulipristal acetate. Fertil Steril. 2014;101(6):1565-73.
Biglia N, Carinelli S, Maiorana A, D'Alonzo M, Lo Monte G, Marci R. Ulipristal acetate: a novel pharmacological approach for the treatment of uterine fibroids. Drug Des Devel Ther. 2014;8:285-92.
Rabe T, Ahrendt HJ, Albring C, Bitzer J, Bouchard P, Cirkel U, et al. Ulipristal Acetate for Symptomatic Uterine Fibroids and Myoma-Related Hypermenorrhea. J Reproduktionsmed Endokrinol. 2013;10(1):82-101.
Monleon J, Martinez-Varea A, Galliano D, Pellicer A. Successful Pregnancy after treatment with Ulipristal acetate for uterine fibroids. Case Rep Obstetr Gynecol. 2014;2014:314587.
Okolo S. Incidence, aetiology and epidemiology of uterine fibroids. Best Pract Res Clin Obstet Gynaecol. 2008;22:571-88.
Marshall LM, Spiegelman D, Barbieri RL, Goldman MB, Manson JE, Colditz GA, et al. Variation in the inci¬dence of uterine leiomyoma among premenopausal women by age and race. Obstet Gynecol. 1997;90(6):967-73.
Day Baird D, Dunson DB, Hill MC, Cousins D, Schectman JM. High cumulative incidence of uterine leiomyoma in black and white women: ultrasound evidence. Am J Obstet Gynecol. 2003;188(1):100-7.
Kjerulff KH, Langenberg P, Seidman JD, Stolley PD, Guzinski GM. Uterine leiomyomas. Racial differences in severity, symptoms and age at diagnosis. J Reprod Med. 1996;41(7):483-90.
Huyck KL, Panhuysen CI, Cuenco KT, Zhang J, Goldhammer H, Jones ES, et al. The impact of race as a risk factor for symptom severity and age at diagnosis of uterine leiomyomata among affected sisters. Am J Obstet Gynecol. 2008;198:168.e1.
Melis GB, Piras B, Marotto MF, Orru MM, Maricosu G, Pilloni M, et al. Pharmacokinetic evaluation of ulipristal acetate for uterine leiomyoma treatment. Expert Opin Drug Metab Toxicol. 2012;8(7):901-8.
Khan AT, Shehmar M, Gupta JK. Uterine fibroids: current perspectives. Int J Womens Heal. 2014;6:95-114.
De Leo V, Morgante G, La Marca A, Musacchio MC, Sorace M, Cavicchioli C, et al. A benefit-risk assessment of medical treatment for uterine leiomyomas. Drug Safety. 2002;25:759-79.
Eisinger SH, Meldrum S, Fiscella K, Le Roux HD, Guzick DS. Low-dose mifepristone for uterine leiomyomata. Obstetr Gynecol. 2003;101:243-50.
Chabbert-Buffet N, Meduri G, Bouchard P, Spitz IM. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update. 2005;11(3):293-307.
Maruo T, Matsuo H, Samoto T, Shimomura Y, Kurachi O, Gao Z, et al. Effects of progesterone on uterine leiomyoma growth and apoptosis. Steroids. 2000;65(10):585-92.
Spitz IM. Clinical utility of progesterone receptor modulators and their effect on the endometrium. Curr Opin Obstet Gynecol. 2009;21(4):318-24.
Talaulikar VS, Manyonda IT. Ulipristal acetate: a novel option for the medical management of symptomatic uterine fibroids. Adv Ther. 2012;29(8):655-63.
Donnez J, Hudecek R, Donnez O, Matule D, Arhendt HJ, Zatik J, et al. Efficacy and safety of repeated use of ulipristal acetate in uterine fibroids. Fertil Steril. 2015;103(2):519-27.