Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation CADTH. Clinical review report. Ulipristal Acetate (Fibristal - Actavis Specialty Pharmaceuticals Co.) indication: uterine fibroids. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Recommendation - Clinical Report. 2014 Authors' conclusions In two phase III RCTs, ulipristal was shown to reduce uterine bleeding in a greater percentage of patients than placebo in PEARL I and to a similar extent as GnRH agonist (i.e., leuprolide) therapy in PEARL II; hence, ulipristal was found to be non-inferior to leuprolide, based on the pre-specified non-inferiority margin of –20% in PEARL II. There were no clear differences between groups in quality of life or non-menstrual bleeding symptom control outcomes detected during 13 weeks of treatment in either study. A large proportion of surgeries were not completed as planned following preoperative study drug treatment, the reasons for which were not provided. Ulipristal treatment appeared generally well tolerated, with comparatively low incidence of WDAEs and SAEs. Of the two trials, headache and hot flashes were the most frequently presenting AEs for ulipristal-treated patients, but neither these nor any other AEs occurred more frequently than observed in the comparator group. However, long-term safety data (beyond three months) for ulipristal is lacking.
Key limitations of the evidence included the lack of North American patients studied, which may reduce
generalizability; the lack of pre-specified surgical end points, which limits the ability to fully evaluate
ulipristal's potential place in therapy; and a lack of data demonstrating superiority over placebo on
validated quality of life instruments — quality of life was identified as a patient-important outcome for
this review.
Indexing Status Subject indexing assigned by CRD MeSH Humans; Leiomyoma; Norpregnadienes Language Published English Country of organisation Canada English summary An English language summary is available. Address for correspondence Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, Ottawa, Ontario Canada, K1S 5S8 Email: requests@cadth.ca AccessionNumber 32014000847 Date abstract record published 17/07/2014 |
