Long-term medical management of uterine fibroids with
ulipristal acetate

J 2016

Long-term medical management of uterine fibroids with ulipristal acetate

DONNEZ, Jacques, Olivier DONNEZ, Dace MATULE, Hans Joachim AHRENDT, Robert HUDEČEK et. al.

Základní údaje

Originální název

Long-term medical management of uterine fibroids with ulipristal acetate

Autoři

DONNEZ, Jacques (56 Belgie), Olivier DONNEZ (56 Belgie), Dace MATULE (428 Lotyšsko), Hans Joachim AHRENDT (276 Německo), Robert HUDEČEK (203 Česká republika, garant, domácí), Janos ZATIK (348 Maďarsko), Zaneta KASILOVSKIENE (440 Litva), Mihai Cristian DUMITRASCU (642 Rumunsko), Hervé FERNANDEZ (250 Francie), David H. BARLOW (826 Velká Británie a Severní Irsko), Philippe BOUCHARD (250 Francie), Bart C.J.M. FAUSER (528 Nizozemské království), Elke BESTEL (756 Švýcarsko) a Ernest LOUMAYE (756 Švýcarsko)

Vydání

Fertility and Sterility, New York, Elsevier Science Inc. 2016, 0015-0282

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30214 Obstetrics and gynaecology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 4.447

Kód RIV

RIV/00216224:14110/16:00089363

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/j.fertnstert.2015.09.032

UT WoS

000373402600027

Klíčová slova anglicky

Ulipristal acetate; uterine fibroid; pain; bleeding; fibroid volume; long-term

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 27. 7. 2016 11:41, Soňa Böhmová

Anotace

V originále

Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. Intervention(s): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. Main Outcome Measure(s): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. Result(s): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness R16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. Conclusion(s): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate.

Citovat

DONNEZ, Jacques, Olivier DONNEZ, Dace MATULE, Hans Joachim AHRENDT, Robert HUDEČEK, Janos ZATIK, Zaneta KASILOVSKIENE, Mihai Cristian DUMITRASCU, Hervé FERNANDEZ, David H. BARLOW, Philippe BOUCHARD, Bart C.J.M. FAUSER, Elke BESTEL a Ernest LOUMAYE. Long-term medical management of uterine fibroids with ulipristal acetate. Fertility and Sterility. New York: Elsevier Science Inc., 2016, roč. 105, č. 1, s. "165"-"173e4", 13 s. ISSN 0015-0282. Dostupné z: https://dx.doi.org/10.1016/j.fertnstert.2015.09.032.

@article{1334878,
   author = {Donnez, Jacques and Donnez, Olivier and Matule, Dace and Ahrendt, Hans Joachim and Hudeček, Robert and Zatik, Janos and Kasilovskiene, Zaneta and Dumitrascu, Mihai Cristian and Fernandez, Hervé and Barlow, David H. and Bouchard, Philippe and Fauser, Bart C.J.M. and Bestel, Elke and Loumaye, Ernest},
   article_location = {New York},
   article_number = {1},
   doi = {http://dx.doi.org/10.1016/j.fertnstert.2015.09.032},
   keywords = {Ulipristal acetate; uterine fibroid; pain; bleeding; fibroid volume; long-term},
   language = {eng},
   issn = {0015-0282},
   journal = {Fertility and Sterility},
   title = {Long-term medical management of uterine fibroids with ulipristal acetate},
   volume = {105},
   year = {2016}
}

TY  - JOUR
ID  - 1334878
AU  - Donnez, Jacques - Donnez, Olivier - Matule, Dace - Ahrendt, Hans Joachim - Hudeček, Robert - Zatik, Janos - Kasilovskiene, Zaneta - Dumitrascu, Mihai Cristian - Fernandez, Hervé - Barlow, David H. - Bouchard, Philippe - Fauser, Bart C.J.M. - Bestel, Elke - Loumaye, Ernest
PY  - 2016
TI  - Long-term medical management of uterine fibroids with ulipristal acetate
JF  - Fertility and Sterility
VL  - 105
IS  - 1
SP  - "165"-"173e4"
EP  - "165"-"173e4"
PB  - Elsevier Science Inc.
SN  - 00150282
KW  - Ulipristal acetate
KW  - uterine fibroid
KW  - pain
KW  - bleeding
KW  - fibroid volume
KW  - long-term
N2  - Objective: To investigate the efficacy and safety of repeated 12-week courses of 5 or 10 mg daily ulipristal acetate for intermittent treatment of symptomatic uterine fibroids. Design: Double-blind, randomized administration of four 12-week courses of ulipristal acetate. Setting: Gynecology centers. Patient(s): Four hundred fifty-one subjects with symptomatic uterine fibroid(s) and heavy menstrual bleeding. Intervention(s): Four repeated 12-week treatment courses of daily 5 or 10 mg ulipristal acetate. Main Outcome Measure(s): Endometrial safety and general safety, laboratory parameters, amenorrhea, controlled bleeding, fibroid volume, quality of life (QoL), and pain. Result(s): Efficacy results, such as bleeding control and fibroid volume reduction, were in line with previously published data. Pain and QoL showed marked improvements from screening, even during the off-treatment intervals. The safety profile of ulipristal acetate was confirmed, and repeated treatment courses did not increase the occurrence of adverse reactions. There were no significant changes in laboratory parameters during the study. The percentage of subjects with endometrial thickness R16 mm was 7.4% (all subjects) after the first treatment course and returned to below screening levels (4.9%) in subsequent treatment courses. As in previous studies, ulipristal acetate did not increase the occurrence of endometrial features of concern. The frequency of nonphysiological changes did not increase with repeated treatment. They were observed in 17.8% and 13.3% of biopsies after treatment courses 2 and 4, respectively, and were reversible after treatment cessation. Conclusion(s): The results of this study demonstrate the efficacy and further support the safety profile of repeated intermittent treatment of symptomatic fibroids with ulipristal acetate.
ER  -

DONNEZ, Jacques, Olivier DONNEZ, Dace MATULE, Hans Joachim AHRENDT, Robert HUDEČEK, Janos ZATIK, Zaneta KASILOVSKIENE, Mihai Cristian DUMITRASCU, Hervé FERNANDEZ, David H. BARLOW, Philippe BOUCHARD, Bart C.J.M. FAUSER, Elke BESTEL a Ernest LOUMAYE. Long-term medical management of uterine fibroids with ulipristal acetate. \textit{Fertility and Sterility}. New York: Elsevier Science Inc., 2016, roč.~105, č.~1, s.~''165''-''173e4'', 13 s. ISSN~0015-0282. Dostupné z: https://dx.doi.org/10.1016/j.fertnstert.2015.09.032.

Podrobný výpis o publikaci