Format

Send to

Choose Destination
Eur J Obstet Gynecol Reprod Biol. 2017 Jan;208:91-96. doi: 10.1016/j.ejogrb.2016.11.003. Epub 2016 Nov 19.

Real world data of 1473 patients treated with ulipristal acetate for uterine fibroids: Premya study results.

Author information

1
Service de Gynécologie Obstétrique, Hôpital Bicêtre, GHU Sud, AP-HP, F-94276, Le Kremlin Bicêtre, France; Inserm, Centre of Research in Epidemiology and Population Health (CESP), U1018, F-94276, Le Kremlin Bicêtre, France; Faculty of Medicine, Univ Paris Sud, F-94276, Le Kremlin Bicêtre, France. Electronic address: herve.fernandez@aphp.fr.
2
PAN-Klinik, Zentrum für gynäkologische Endoskopie, Zeppelinstraße 1, 50667 Köln, Germany.
3
CircleNottingham, Nottingham NHS Treatment Centre, Queen's Medical Centre Campus, Lister Road, Nottingham, NG7 2FT, United Kingdom.
4
Hospital do Espírito Santo - Évora, EPE, Gynaecology and Obstetrics Department, Largo Senhor da Pobreza, 7000-811, Évora, Portugal.
5
Gedeon Richter/Preglem S.A., Route de Frontenex 41A, 1207 Geneva, Switzerland.
6
Department of Obstetrics and Gynecology, Ludwig Maximilians Universität, Marchioninistr. 15, D-81377 Munich, Germany.

Abstract

OBJECTIVES:

To characterize and describe treatment with Ulipristal acetate (UPA) in a pre-operative setting and to evaluate the safety, effectiveness, and Health Related Quality of Life (HRQoL) outcomes in a population treated according to standard clinical practice in the EU.

STUDY DESIGN:

Multi-centre, prospective, non-interventional study (PREMYA) of patients diagnosed with moderate to severe symptoms of uterine fibroids and undergoing a pre-operative treatment with UPA (Esmya®) at 73 clinical practice sites within the EU. Patients were followed during UPA treatment and for 12 months after treatment discontinuation for a total of 15 months follow-up. Data was collected every 3 months in accordance with standard care visits.

RESULTS:

A total of 1568 women were enrolled, of whom 1473 were found to be eligible for data analysis. Only 38.8% of patients underwent surgery, of which the majority were of a conservative/minimally invasive nature. Physicians' assessments of patients' overall symptomatic change, as measured on the Clinical Global Impression-Improvement (CGI-I) scale, indicated that 60% of patients were much improved or very much improved at 3 months. Pain and quality of life after treatment cessation remain lower than baseline during the entire period of follow-up CONCLUSIONS: The majority of patients do not undergo surgery immediately after treatment cessation. Quality of life and pain are highly improved by Esmya® treatment.

KEYWORDS:

Bleeding; Pain; Quality of life; Ulipristal acetate; Uterine fibroids

PMID:
27898340
DOI:
10.1016/j.ejogrb.2016.11.003
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center