Concerns were raised by drug regulators in 2018 about a potential link between liver injury and use of the drug ulipristal acetate (5 mg) which is prescribed for the treatment of uterine fibroid in women. This observation however was made among only a small number of women with uterine fibroids. To understand whether a research study to look more closely at this question is possible, primary care and hospital data collected by the Clinical Practice Research Datalink (CPRD) will be used to examine the records of a larger pool of women with uterine fibroids. We would like to find out how many women had a diagnosis of uterine fibroid in the CPRD since 2010, the number of who were treated or not treated with the drug and the medical conditions that they had before and after 2010. We are especially interested in the numbers of women who used ulipristal acetate and have a report of liver problems and the numbers who never used the drug and had a diagnosis of liver problems.
Counts from this feasibility study will help us to decide whether data from CPRD alone can be used to undertake this study or whether we may also need to obtain data from other data sources to address the study question.
For appropriate power calculation, information is being collected as follows:
Size of study population:
- GROUP1: Women (18-55 years) taking Esmya
- GROUP2: Women with incident or prevalent diagnosis of uterine fibroids recorded on or after 01/01/2010, aged 18-55 at date of first diagnosis captured after 01/01/2010 who never prescribed Esmya 5mg
Cumulative follow-up time:
- GROUP1:
- Total number of women with minimum 12 months of follow-up in the CPRD prior to index date of uterine fibroid diagnosis
- Total cumulative follow-up time of Esmya use defined as the time from date of first Esmya prescription day until up to 196 days following last prescription.
- GROUP2:
- Total number of women with minimum 12 months of follow-up in the CPRD prior to index date of uterine fibroid diagnosis
- Total follow-up time of patients with uterine fibroids from date of first diagnosis until any record indicative of uterine surgery or up to date, whichever earlier.
- Number of patients in GROUP 2 with for whom date of first diagnosis equals uterine surgery date
Number of events (all below for both GROUP1 and GROUP2, respectively).
- Number of patients with any record of acute liver injury
- Separate counts of number of patients with
- potential toxic liver injury including Drug Induced Liver Injury,
- autoimmune liver disease,
- Liver transplantation,
- Severe liver disease of interest,
- any abnormal liver function test (defined both by Read codes and laboratory test values)
- Number of patients with codes indicative of liver injury/liver disease in HES
(Data about number of patients matching several of above categories also requested. Above list is preliminary.)
- Number of patients with any liver function test result available
CPRD data may be integrated with information from other sources to calculate statistical power of planned study.
Diagnosis of Liver injury (autoimmune liver disease, liver transplant, severe liver disease), Liver function tests
Kevin Moore - Chief Investigator - University College London ( UCL )
Krisztian Nagy - Corresponding Applicant - Auxiliis Pharma
Wouter Wijker - Collaborator - Auxiliis Pharma
HES Admitted Patient Care;HES Outpatient