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High-Dose Cyproterone Acetate and Intracranial Meningioma: Impact of the Risk Minimisation Measures Implemented in
Noémie Roland1, Anke Neumann1, Bérangère Baricault1
1EPI-PHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products-ANSM, French National Health Insurance-CNAM), Saint-Denis, France.
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.
Results:
Between 2018 and 2021, the number of individuals exposed to CPA fell by 85% (55 000 in August 2018 versus 7900 users of high-dose CPA in December 2021), corresponding to two waves of decrease in both use and initiation. This drop was greater among cisgender women (88%) than men (69%) or transgender women (50%). Cerebral imaging screening increased from 11% in June 2018 to 70% in June 2021 for ciswomen (13%-51% for men, 9%-60% for transwomen). After CPA discontinuation, no massive shift to a single product was observed, but, instead, dispersion towards other hormonal therapies. The overall annual rate of meningioma surgery associated with CPA exposure spectacularly decreased between 2017 and 2021 (-93% for ciswomen and -86% for men).
Conclusion:
In France, high-dose CPA use sharply decreased after the implementation of national regulatory measures without a massive switch to other hormonal therapies. The increase in cerebral imaging screening did not result in an increase in meningioma surgery associated with CPA, but rather a massive drop of over 90%.
