AW and JC devised and you can prepared the study. AW written the newest manuscript. BC performed data administration. BC and you will PN did statistical analyses. AW and you may JC made sure project and read management. The people (AW, PN, ML, BC, TP, LD, ALB, IY, SFo, SFr, and you will JC) triggered interpretation of analysis and you will changed the manuscript. All the authors acknowledged the past manuscript. The brand new corresponding creator (AW) attests that all noted people fulfill crafting conditions which zero other people fulfilling the newest requirements was in fact omitted. AW and you may JC will be the guarantors.
Funding: This research is financed from the French Federal Medical insurance Fund (CNAM) and the Fitness Product Epidemiology Scientific Appeal Group (ANSM-CNAM EPI-PHARE SIG). AW, JC, and you will BC was team from French Federal Health insurance Finance, PN are a member of staff of the French National Agency having Medication and you can Health Circumstances Protection. Today’s report stands for the opinions of your own people and you can really does not at all times echo the career of the companies.
Contending interests: Every article writers get done the newest ICMJE consistent disclosure form from the and you will declare: assistance off French Federal Medical insurance Finance (CNAM) and also the Fitness Product Epidemiology Medical Focus Class (ANSM-CNAM EPI-PHARE SIG) with the submitted really works; no monetary matchmaking with one companies that may have an interest regarding the registered operate in the earlier 3 years; no other relationships or activities which will appear to have influenced the fresh new filed works.
Top honors author (AW) affirms that the manuscript try an honest, direct and transparent membership of the data are stated; one no key factors of analysis had been excluded; and therefore one inaccuracies throughout the studies while the structured (and you may, when the relevant, registered) was in fact explained.
Dissemination so you can users and you will associated diligent and public organizations: The outcomes was presented to patient organization agents. Patients who’d made use of cyproterone acetate mg along side earlier a few age (and their general practitioners) received a development page home bringing more information about what doing (second material S18).
Variety of recognized evidence in women and you can girls and you may business regarding highest dosage cyproterone acetate (ten mg and 50 mg) by nation when you look at the Europe
Analysis communities
A few almost every other susceptibility analyses was basically conducted: study of your own 2007-14 started otherwise control classification main cohort who had been coordinated getting age within initiation and you will time of go after-right up, and you will a nested circumstances-handle learn from the latest 2007-14 fundamental cohort.
Results
Occurrence, relative chance, and you will modified hazard ratio regarding meningioma based on exposure to cyproterone acetate (main cohort, 2007-14; n=253 777)
The newest estimated number of people which have meningioma due to cyproterone acetate is over 500 from inside the France toward months 2007-fifteen (62 per year; supplementary question S16). So it estimate is dependent on an old-fashioned calculation that does not be the cause of people who have a diagnosis one or more season immediately following discontinuation of cyproterone acetate, people who have an analysis once a first category out of really some established (control classification) and you will next resumption out of cyproterone acetate, and you can meningiomas treated from the medical pursue-up in the place of functions otherwise radiotherapy.
Additionally, the current presence of progesterone receptors in arachnoid structure, where meningiomas happen, could have been recognized for five ages.5556575859 Several authors features claimed an effective heterogeneous shipment out-of progesterone receptors according to website out of meningiomas. A great rostrocaudal gradient of progesterone receptors, that have increased density regarding receptors throughout the skull base, keeps have a tendency to become reported, and is actually confirmed by several publications.6061 Our interested in away from an effective predominance out of prior head legs meningiomas pertaining to usage of cyproterone acetate, good progestogen, try consistent with such biological conclusions.
Strengths associated with the studies
Numerous constraints plus concern this new medical and you may histological features out-of meningioma. SNDS doesn’t have studies into result of magnetized resonance imaging otherwise histology, otherwise if meningiomas try unmarried otherwise multiple, with the exception of operations you to definitely include collection of anatomical places.
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