Ameli, health insurance site, takes up the information:
Androcur and generics: reduction in the risk of meningioma thanks to new practices
The EPI-Phare scientific interest group (GIS EPI-Phare) led, from the National Health Data System (SNDS), a study (1) relating to the period 2010-2021 in order to measure the impact of the actions implemented from 2018 by the National Agency for the Safety of Medicines and Health Products (ANSM) and Health Insurance to combat the risk of meningiomas linked to the use of acetate Cyproterone. The study highlights profound changes in practices, which have allowed a significant reduction in risk.
Decrease in the use of cyproterone acetate (Androcur and generics)
In 2018, the risk of meningiomas linked to the prolonged use of cyproterone acetate at high doses (greater than or equal to 25 mg/day) was quantified for the first time by health insurance. The study showed that it is multiplied by 7 for women treated with high doses over a long period (more than 6 months) and by 20 after 5 years of treatment.
The recent study by Epi-Phare is the first to demonstrate the profound change in practices in the use of Androcur and its generics since the implementation of new recommendations in 2018 .
It highlights a significant decrease, between August 2018 and December 2021, of the use of cyproterone acetate in high doses in all those exposed and especially in women :
- – 88 % in women ;
- – 69 % in men ;
- – 50 % in transgender women.
In total, in December 2021, 7,900 people used cyproterone acetate in high doses against 55,000 in August 2018.
This drop is linked to treatment stops (92 % of people treated in June 2018 had stopped their treatment in 2021) and the decrease in treatment initiations (- 94 %) .
Best monitoring by imaging of people treated by cyproterone acetate
The study also shows a clear improvement in imaging monitoring, in accordance with the recommendations of the ANSM, since brain MRI screening in patients under cyproterone acetate has significantly progressed .
In 2021 , more than 50 % of them carried out this exam (70 % of women and 50 % of men) against less than 10 % in 2018.
However, in December 2021, the MRI production rate to the initiation of treatment, necessary since July 2019, remained less than 50 %.
Decrease in meningioma surgical ablations linked to cyproterone acetate
It is established that the size of the meningiomas associated with cyproterone acetate decreases or stabilizes when stopping treatment, which is why their systematic removal by heavy surgery and at risk is not to be favored.
The study reveals a very sharp decrease in the number of meningioma operations in connection with Androcur and its generics (- 93 %) , especially among women (7 operations in 2021 against 95 in 2017).
The actions carried out by the ANSM with the support of health insurance made it possible to very significantly reduce the risk of meningioma linked to the use of Androcur and its generics.
The impact study should be continued, in the same way as those devoted to nomestrol and chlormadinone acetate, currently being completed.
(1) Use of High dose Cyproterone Acetate and Risk of Intracranial Meningioma in Women: Cohort Study. BMJ 2021; 372: N37.
Reminder of the recommendations in the event of a cyproterone acetate prescription
- Outside AMM indications such as acne, seborrhea and moderate hirsutism are to be avoided ;
- The use of cyproterone acetate in children and menopausal women is not recommended ;
- prescription (indication and dosage) must be reassessed annually ;
- the effective minimum dosage to control symptoms should be used ;
- prolonged and high doses uses are to be avoided ;
- An annual information certificate must be coined each year by the prescribing doctor and his patient (it is essential for the delivery of the product in pharmacies) ;
- IRM brain imaging should be carried out at the start of treatment for all patients ;
- In the event of a continuation of treatment, the MRI will be renewed at 5 years then every 2 years ;
- In the event of a meningioma discovery, the treatment must be stopped permanently. A neurosurgical opinion is recommended.
