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Fernandez, Herve; Schmidt, Torsten; Powell, Martin; Freitas Costa, Ana Patricia; Arriagada, Pablo; Thaler, Christian (2017): Real world data of 1473 patients treated with ulipristal acetate for uterine fibroids: Premya study results. In: European Journal of Obstetrics & Gynecology and Reproductive Biology, Vol. 208: pp. 91-96
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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 (R)) 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 (R) treatment.