Category: Professional Posters
Purpose: Ulipristal acetate (UPA), is a selective progesterone-receptor modulator, it decreases fibroid size and reduces menstrual bleeding. On 31 May 2018, the European Medicines Agency (EMA) recommended that several measures be put in place to minimise the risk of rare but serious liver injury with Esmya (UPA). This study was designed to evaluate the long term safety of UPA in real-world practice, with focus on liver safety.
Methods: This retrospective study consisted up to 8 consecutive 3-month courses of daily UPA 5mg. The electronic records of patients treated with UPA from January 2014 to December 2018 were reviewed. The main outcome measures were included the liver function test values (alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total bilirubin) and symptoms of liver injury.
Results: All data was reported in a descriptive manner with no formal statistical comparisons. The 189 pre-menopausal women, with moderate to severe symptomatic uterine fibroids, were included. The median age was 45 years (range, 19-58 years) and the median number of intermittent treatment courses was 3 intermittent courses (range, 1-8 courses). All patients received 5mg/day UPA. No patients reported ALT/AST > 5×Upper Limit Normal (ULN) or ALP > 2×ULN or the combination of ALT/AST >3×ULN and total bilirubin >2×ULN during long-term intermittent treatment courses with 5mg UPA. Five patients (2.6%) reported ALT/AST > 3×ULN, but no signs of liver injury are identified.
Conclusion: In this retrospective study, repeated UPA treatment did not present the signal of hepatic toxicity. The results of this study support the liver safety profile of extended use with UPA 5 mg/day. Based on the recent EMA review, the benefit/risk ratio of UPA remains positive, considering that periodic liver monitoring before, during, and after treatment with UPA for the prevention of rare risk of liver toxicity.