Publications by authors named "Isabelle Yoldjian"
Purpose: To measure the impact of national regulatory actions implemented in France in August 2018 and June 2019 to reduce the risk of meningioma associated with the use of cyproterone acetate (CPA).
Methods: Using the French National Healthcare database, we calculated the monthly number of CPA users among cisgender women, men and transgender women in 2010-2021, the monthly proportion of users with cerebral imaging screening, and the annual rate of meningioma surgery associated with CPA use. CPA discontinuations and switches were analysed.
The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.
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- The study investigates the behavior of progestin-related osteomeningiomas after stopping hormonal treatment, focusing on a group of 36 patients who had used specific progestins.
- Results indicate that while the soft tissue part of these tumors tends to shrink after treatment discontinuation (77.1%), the bony component often increases in size (81.3%), especially with longer progestin use and estrogen combination.
- The findings highlight the importance of careful monitoring for patients with these tumors after they stop progestin treatment due to the differing responses of the tumor's soft and bony components.
Decisions on market authorization (MA) and reimbursement have different durations across countries because of health technology assessment (HTA) procedures and negotiations between manufacturers and national authorities. To overcome this delay, France has implemented a Temporary Authorization for Use (ATU) program that allows early access to drugs before MA, in order to treat patients with unmet medical needs. The objectives of our study were to establish the added therapeutic benefit (ATB) of ATUs for solid tumors and to investigate the correlations between three tools evaluating ATB and survival outcomes and drug costs.
View Article and Find Full Text PDFBackground: The behavior of meningiomas under influence of progestin therapy remains unclear.
Objective: To investigate the relationship between growth kinetics of intracranial meningiomas and usage of the progestin cyproterone acetate (PCA).
Methods: This study prospectively followed 108 women with 262 intracranial meningiomas and documented PCA use.
Objective: To assess the risk of meningioma associated with use of high dose cyproterone acetate, a progestogen indicated for clinical hyperandrogenism.
Design: Observational cohort study.
Setting: Data from SNDS, the French administrative healthcare database, between 2007 and 2015.