title: Real world data of 1473 patients treated with ulipristal acetate for uterine fibroids: Premya study results.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: 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.
authors.forename: Hervé
authors.initials: H
authors.lastname: Fernandez
authors.affiliation: PAN-Klinik, Zentrum für gynäkologische Endoskopie, Zeppelinstraße 1, 50667 Köln, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Schmidt
authors.affiliation: CircleNottingham, Nottingham NHS Treatment Centre, Queen's Medical Centre Campus, Lister Road, Nottingham, NG7 2FT, United Kingdom.
authors.forename: Martin
authors.initials: M
authors.lastname: Powell
authors.affiliation: Hospital do Espírito Santo - Évora, EPE, Gynaecology and Obstetrics Department, Largo Senhor da Pobreza, 7000-811, Évora, Portugal.
authors.forename: Ana Patrícia Freitas
authors.initials: AP
authors.lastname: Costa
authors.affiliation: Gedeon Richter/Preglem S.A., Route de Frontenex 41A, 1207 Geneva, Switzerland.
authors.forename: Pablo
authors.initials: P
authors.lastname: Arriagada
authors.affiliation: Department of Obstetrics and Gynecology, Ludwig Maximilians Universität, Marchioninistr. 15, D-81377 Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Thaler
mesh_terms: D015746:Abdominal Pain / Q000209:etiology / Q000517:prevention & control; D000328:Adult; D015331:Cohort Studies; D003270:Contraceptive Agents / Q000009:adverse effects / Q000627:therapeutic use; D005062:European Union; D005260:Female; D005500:Follow-Up Studies; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists*; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects; D007889:Leiomyoma / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D018231:Leiomyomatosis / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D008875:Middle Aged; D009649:Norpregnadienes / Q000009:adverse effects / Q000627:therapeutic use*; D059351:Organ Sparing Treatments / Q000009:adverse effects; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index; D014591:Uterine Diseases / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery; D014592:Uterine Hemorrhage / Q000209:etiology / Q000517:prevention & control; D063186:Uterine Myomectomy / Q000009:adverse effects; D014594:Uterine Neoplasms / Q000188:drug therapy* / Q000503:physiopathology / Q000601:surgery
chemical_list: D003270:Contraceptive Agents; D009649:Norpregnadienes; D007987:Gonadotropin-Releasing Hormone; C555622:ulipristal acetate
keywords: Bleeding; Pain; Quality of life; Ulipristal acetate; Uterine fibroids