REAL WORLD DATA OF 1473 PATIENTS TREATED WITH ULIPRISTAL ACETATE FOR UTERINE FIBROIDS: PREMYA STUDY RESULTS

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 M...

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Bibliographic Details
Published in:European journal of obstetrics & gynecology and reproductive biology 2017-01, Vol.208, p.91-96
Main Authors: Fernandez, Hervé, Schmidt, Torsten, Powell, Martin, Costa, Ana Patrícia Freitas, Arriagada, Pablo, Thaler, Christian
Format: Article
Language:English
Subjects:
Abdominal Pain - etiology
Abdominal Pain - prevention & control
Adult
Bleeding
Cohort Studies
Contraceptive Agents - adverse effects
Contraceptive Agents - therapeutic use
European Union
Female
Follow-Up Studies
Gonadotropin-Releasing Hormone - agonists
Humans
Hysterectomy - adverse effects
Leiomyoma - drug therapy
Leiomyoma - physiopathology
Leiomyoma - surgery
Leiomyomatosis - drug therapy
Leiomyomatosis - physiopathology
Leiomyomatosis - surgery
Middle Aged
Norpregnadienes - adverse effects
Norpregnadienes - therapeutic use
Obstetrics and Gynecology
Organ Sparing Treatments - adverse effects
Pain
Prospective Studies
Quality of Life
Severity of Illness Index
Ulipristal acetate
Uterine Diseases - drug therapy
Uterine Diseases - physiopathology
Uterine Diseases - surgery
Uterine fibroids
Uterine Hemorrhage - etiology
Uterine Hemorrhage - prevention & control
Uterine Myomectomy - adverse effects
Uterine Neoplasms - drug therapy
Uterine Neoplasms - physiopathology
Uterine Neoplasms - surgery
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Summary: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.
ISSN:0301-2115
1872-7654
DOI:10.1016/j.ejogrb.2016.11.003