Roland Noémie, Neumann Anke, Baricault Bérangère, Dayani Pauline, Duranteau Lise, Fontanel Sylvie, Yoldjian Isabelle, Froelich Sébastien, Zureik Mahmoud, Weill Alain
EPI-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.
French National Agency for the Safety of Medicines and Health Products (ANSM), Saint-Denis, France.
Pharmacoepidemiol Drug Saf. 2025 Jan;34(1):e70078. doi: 10.1002/pds.70078.
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).
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.
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).
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%.
评估2018年8月和2019年6月法国实施的国家监管行动对降低醋酸环丙孕酮（CPA）使用相关脑膜瘤风险的影响。
利用法国国家医疗数据库，我们计算了2010 - 2021年顺性别女性、男性和跨性别女性中CPA使用者的月度数量、进行脑部成像筛查的使用者月度比例以及与CPA使用相关的脑膜瘤手术年发生率。分析了CPA停药和换药情况。
2018年至2021年期间，接触CPA的人数下降了85%（2018年8月为55000人，2021年12月高剂量CPA使用者为7900人），对应使用和起始的两波下降。这种下降在顺性别女性中（88%）比男性（69%）或跨性别女性（50%）更大。顺性别女性的脑部成像筛查从2018年6月的11%增加到2021年6月的70%（男性为13% - 51%，跨性别女性为9% - 60%）。在停用CPA后，未观察到向单一产品的大规模转移，而是转向了其他激素疗法。2017年至2021年期间，与CPA接触相关的脑膜瘤手术总体年发生率大幅下降（顺性别女性下降93%，男性下降86%）。
在法国，实施国家监管措施后，高剂量CPA的使用急剧下降，且未大规模转向其他激素疗法。脑部成像筛查的增加并未导致与CPA相关的脑膜瘤手术增加，反而大幅下降了90%以上。
