Long-term medical management of uterine fibroids with ulipristal acetate

Donnez, Jacques; Donnez, Olivier; Matule, Dace; Ahrendt, Hans-Joachim; Hudeček, Robert; Zatik, János; Kasilovskienė, Žaneta; Dumitrașcu, Mihai Cristian; Fernandez, H.; Barlow, David H.; Bouchard, Philippe; Fauser, Bart C.J.M.; Bestel, Elke; Loumaye, Ernest

doi:10.1016/j.fertnstert.2015.09.032

Cited by 150 publications

(149 citation statements)

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“…Previous clinical studies illustrated the reversibility of PAEC induced by UPA on endometrial biopsies [3] [4]. Moreover, the occurrence of non-physiological changes of the endometrium does not increase with up to 4 treatment courses and returns to pretreatment levels within 3 months of completion of treatment, as recently reported [7]. …”

Section: Introductionmentioning

confidence: 58%

“…The effect of repeated intermittent use of UPA 5 or 10 mg daily (up to 4 courses) have been previously studied [7]; However long term safety of up to 8 courses of treatment separated by off treatment periods of 2 menstrual cycles, for up to 4 years of treatment and subject follow up in total, considering the long term safety implications, is believed to be of special interest for clinicians. Under such circumstances, UPA may be employed in women of more advanced reproductive age approaching menopause avoiding the need for any surgery.…”

Section: Introductionmentioning

confidence: 99%

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Safety after extended repeated use of ulipristal acetate for uterine fibroids

et al. 2017

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ObjectiveTo assess long term safety of extended repeated 3-month courses of ulipristal acetate (UPA) 10 mg/day, for up to 8 courses, with focus on endometrial and laboratory safety parameters.MethodsThis long-term, multi-center, open-label cohort, follow up study consisted of up to 8 consecutive 3-month courses of daily UPA 10 mg, each separated by a drug free period of 2 spontaneous menstrual bleeds. Sixty-four pre-menopausal women, with moderate to severe symptomatic uterine myoma(s) and heavy bleeding were enrolled and were studied for approximately 4 years. The main outcome measures were endometrial histology, laboratory parameters and general safety.ResultsAll data was reported in a descriptive manner with no formal statistical comparisons. In the 64 women, non-physiological changes (mostly cyst formation, epithelial and vascular changes) in endometrial histology at screening and after treatment courses 4 and 8 were observed in 18.0%, 21.4% and 16.3% of biopsies, respectively. After treatment cessation, such changes were observed in 9.1% of biopsies. All endometrial biopsies were benign after course 8. The median endometrial thickness was 7.0 mm, 10–18 days after the start of menses following treatment courses 5–8, compared to 9.0 mm at screening (before UPA treatment). No changes in the number and type of laboratory results outside the normal ranges were observed with the increasing treatment courses. In total, adverse events were reported in 10 (16%), 12 (19%), 8 (14%) and 5 (9%) subjects, during treatment courses 5, 6, 7 and 8, respectively of which the most frequent adverse events were headache and hot flush.ConclusionThe results of this study further support the safety profile of extended repeated 3 months treatment of symptomatic fibroids with ulipristal acetate 10 mg/day. Repeated UPA treatment courses did not result in any changes of concern in endometrial histology, endometrial thickness, or laboratory safety measures.

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Section: Introductionmentioning

confidence: 58%

Section: Introductionmentioning

confidence: 99%

Safety after extended repeated use of ulipristal acetate for uterine fibroids

et al. 2017

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“…After four treatment courses, amenorrhea was seen in 63% of those who took 5 mg UPA per day as compared to 73% of those who took 10 mg UPA per day. Fibroid volume reduced by 73% in both groups [18].…”

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confidence: 89%

Medical Management of Symptomatic Fibroids: Worth It?

Hegde¹

2017

J Obstet Gynecol India

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“…Дан-ные показания основываются на результатах 3 фазы серии исследований (PEARL I, PEARL II, PEARL III, PEARL IV), степень доказательности А1 [20,21,22]. Лечение эндометриоза пока не входит в показания для приема УПА.…”

Section: подходы к медикаментозному лечению сочетанной патологии маткиunclassified

Concomitant endometriosis and leiomyoma in women of reproductive age

Zaporozhchenko

Сидоренко

Парубина

2017

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Endometriosis and leiomyoma commonly co-exist inside one uterus. Specialized surgical centers report detection frequency of comorbid endometriosis during surgery or laparoscopy that varies from 20 to 87% in patients with symptomatic fibroids.In authors practice the histological study of surgery samples from patients diagnosed with symptomatic fibroids (113 hysterectomies) revealed concomitant endometriosis in 26.5% cases.Clinical and morphological analysis showed that in patients with multiply fibroids, large volumes or submucous myomas comorbid adenomyosis doesn’t interfere significantly with the clinic course. But in cases of small-size solitary intramural or subserosis fibroids the clinic of symptomatic myomas is determined by the comorbid adenomyosis of diffuse-nodular or diffuse-lesion forms and 2–3 stages.Thus, endometriosis associated with leiomyomas causes more severe course of comorbidity. Patients with symptomatic fibroids are exposed to higher risk of endometriosis development, which must be kept in mind when planning the surgery treatment. Authors propose to enhance laparoscopic myomectomy with target revision of pelvis to reveal possible endometriosis, because laparoscopy provides the best opportunity to visualization of endometriosis lesions.The choice of pharmacotherapy of concomitant uterine pathology is limited. Gonadotropin-releasing hormone agonists is the only currently available group of drugs that labeled both for the treatment of endometriosis and fibroids. Selective progesterone-receptor modulator ulipristal acetate due to its unique antiproliferative and selective proapoptotic effect on the leiomyomas cellular component is very promising in the uterine-sparing therapy of myomas. In addition, it has pharmacodynamic effects on the endometrium, including antiproliferative effects that may contribute to the treatment of endometriosis. Clinical trial of ulipristal on this indication is ongoing (NCT02213081). For the present, in the absence of approved algorithms for the treatment of co-morbid pathology, the individual approach with combining preparations of different classes is relevant.

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Long-term medical management of uterine fibroids with ulipristal acetate

Abstract: NCT01629563.

Cited by 150 publications

References 11 publications

Safety after extended repeated use of ulipristal acetate for uterine fibroids

Safety after extended repeated use of ulipristal acetate for uterine fibroids

Medical Management of Symptomatic Fibroids: Worth It?

Concomitant endometriosis and leiomyoma in women of reproductive age

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