Note de l’association : ces mesures ont été prises dans le groupe de travail « Méningiomes et progestatifs » à l’ANSM, dans lequel l’association siège depuis sa création en janvier 2019.
Informer que l’opération n’est pas toujours obligatoire, car les méningiomes peuvent régresser à l’arrêt du traitement hormonal, est aussi un trvail de fonds de l’association depuis sa création.

Context

In 2018, an increased risk, dependent dose-effect, intracranial meningiomas linked to the prolonged use of cyproterone acetate in high doses (> = 25 mg/day), was quantified and made public in France. Risk reduction measures have been taken by the health authorities with information from health professionals and patients, a recall of the indications aimed at limiting the use and screening of meningiomas by brain MRI.

Objective

The objective of this study was, from data from the National Health Data System (SNDS), to measure the impact of the actions implemented to reduce the risk of meningiomas linked to the use of cyproterone acetate.

Results

Between August 2018 and December 2021 The number of people treated by high-dose cyproterone acetate decreased by 85%, with a more marked drop for women (-88%) than for men (-69%) and transgender women (-50%). In December 2021 7,900 people used Cyproterone acetate in high doses against 55,000 in August 2018 and 85,000 in January 2010. This drop resulted from a large number of treatment stops during the first wave of actions at the end of August 2018 (initial information with very important media coverage, renowning of good use and establishment of surveillance by MRI with doctors) but also during the second wave in June and July 2019 with nominative letters to doctors and patients, and the implementation of an "annual information certificate" to be co -signed by the doctor and patient. Thus almost 92% of people treated in June 2018 no longer continued their treatment in December 2021 with a marked peak after each of the waves of shares in October 2018 and July 2019. We did not find a massive postponement on a given product but a dispersion to other usual hormones (for women 35%) and the Spironolactone, anti -diarogenic effect (for women 5% and for men 3%). Cyproterone acetate establishments fell between June 2018 and December 2021 by more than 94 %.

Le recours aux IRM cérébrales de dépistage de méningiome est devenu fréquent, quoique non systématique, avec près de 70% des femmes utilisatrices d’acétate de cyprotérone en décembre 2021 qui ont réalisé cette imagerie et à un niveau moindre près de 50% des hommes (en août 2018, avant les actions ces taux étaient de 11% et 13%, respectivement). Pour les initiations d’acétate de cyprotérone le recours aux IRM a été inférieur, 45% pour les femmes et 32% chez les hommes.
Le nombre annuel de femmes opérées de méningiome intracrânien, au cours ou dans l’année suivant une exposition à l’acétate de cyprotérone, s’est ainsi réduit de 95 femmes opérées en 2017 à 7 en 2021, soit -93%.

Conclusion

In total, the actions carried out have greatly reduced the consumption of cyproterone acetate, which has since resulted in a collapse of the number of new intracranial meningiomas operated and attributable to this medication.