Efficacy and safety of vilaprisan in women with uterine
fibroids: Data from the phase 2b randomized controlled trial
ASTEROID 2

J 2020

Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2

GEMZELL-DANIELSSON, Kristina, Oskari HEIKINHEIMO, Janos ZATIK, Robert POKA, Tomasz RECHBERGER et. al.

Základní údaje

Originální název

Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2

Autoři

GEMZELL-DANIELSSON, Kristina (752 Švédsko), Oskari HEIKINHEIMO (246 Finsko), Janos ZATIK (348 Maďarsko), Robert POKA (348 Maďarsko), Tomasz RECHBERGER (616 Polsko), Robert HUDEČEK (203 Česká republika, domácí), Kathrin PETERSDORF (276 Německo), Francisco RAMIREZ (276 Německo), Thomas FAUSTMANN (276 Německo), Esther GROETTRUP-WOLFERS a Christian SEITZ (276 Německo, garant)

Vydání

EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY, AMSTERDAM, ELSEVIER SCIENCE BV, 2020, 0301-2115

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30214 Obstetrics and gynaecology

Stát vydavatele

Německo

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 2.435

Kód RIV

RIV/00216224:14110/20:00116813

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1016/j.ejogrb.2020.05.043

UT WoS

000573036000002

Klíčová slova anglicky

Vilaprisan; Heavy menstrual bleeding; Uterine fibroids; Amenorrhea; Selective progesterone receptor modulator

Štítky

14110411, GPK, GPKgyn, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 11. 11. 2020 11:19, Mgr. Tereza Miškechová

Anotace

V originále

Objective: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. Study design: The randomized, parallel-group, double-blind, placeboand active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with >1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. Results: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (80 mL and 50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. Conclusion: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. (C) 2020 Published by Elsevier B.V.

Citovat

GEMZELL-DANIELSSON, Kristina, Oskari HEIKINHEIMO, Janos ZATIK, Robert POKA, Tomasz RECHBERGER, Robert HUDEČEK, Kathrin PETERSDORF, Francisco RAMIREZ, Thomas FAUSTMANN, Esther GROETTRUP-WOLFERS a Christian SEITZ. Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2. EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY. AMSTERDAM: ELSEVIER SCIENCE BV, 2020, roč. 252, SEP 2020, s. 7-14. ISSN 0301-2115. Dostupné z: https://dx.doi.org/10.1016/j.ejogrb.2020.05.043.

@article{1688898,
   author = {GemzellandDanielsson, Kristina and Heikinheimo, Oskari and Zatik, Janos and Poka, Robert and Rechberger, Tomasz and Hudeček, Robert and Petersdorf, Kathrin and Ramirez, Francisco and Faustmann, Thomas and GroettrupandWolfers, Esther and Seitz, Christian},
   article_location = {AMSTERDAM},
   article_number = {SEP 2020},
   doi = {http://dx.doi.org/10.1016/j.ejogrb.2020.05.043},
   keywords = {Vilaprisan; Heavy menstrual bleeding; Uterine fibroids; Amenorrhea; Selective progesterone receptor modulator},
   language = {eng},
   issn = {0301-2115},
   journal = {EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY},
   title = {Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2},
   url = {https://www.sciencedirect.com/science/article/pii/S0301211520303262?via%3Dihub},
   volume = {252},
   year = {2020}
}

TY  - JOUR
ID  - 1688898
AU  - Gemzell-Danielsson, Kristina - Heikinheimo, Oskari - Zatik, Janos - Poka, Robert - Rechberger, Tomasz - Hudeček, Robert - Petersdorf, Kathrin - Ramirez, Francisco - Faustmann, Thomas - Groettrup-Wolfers, Esther - Seitz, Christian
PY  - 2020
TI  - Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2
JF  - EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY
VL  - 252
IS  - SEP 2020
SP  - 7-14
EP  - 7-14
PB  - ELSEVIER SCIENCE BV
SN  - 03012115
KW  - Vilaprisan
KW  - Heavy menstrual bleeding
KW  - Uterine fibroids
KW  - Amenorrhea
KW  - Selective progesterone receptor modulator
UR  - https://www.sciencedirect.com/science/article/pii/S0301211520303262?via%3Dihub
L2  - https://www.sciencedirect.com/science/article/pii/S0301211520303262?via%3Dihub
N2  - Objective: To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. Study design: The randomized, parallel-group, double-blind, placeboand active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with >1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. Results: Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (80 mL and 50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. Conclusion: Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. (C) 2020 Published by Elsevier B.V.
ER  -

GEMZELL-DANIELSSON, Kristina, Oskari HEIKINHEIMO, Janos ZATIK, Robert POKA, Tomasz RECHBERGER, Robert HUDEČEK, Kathrin PETERSDORF, Francisco RAMIREZ, Thomas FAUSTMANN, Esther GROETTRUP-WOLFERS a Christian SEITZ. Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2. \textit{EUROPEAN JOURNAL OF OBSTETRICS \&{}amp; GYNECOLOGY AND REPRODUCTIVE BIOLOGY}. AMSTERDAM: ELSEVIER SCIENCE BV, 2020, roč.~252, SEP 2020, s.~7-14. ISSN~0301-2115. Dostupné z: https://dx.doi.org/10.1016/j.ejogrb.2020.05.043.

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