title: Risk of meningioma among users of high doses of cyproterone acetate as compared with the general population: evidence from a population-based cohort study.
abstract: OBJECTIVE
  Information from the spontaneous reporting system raised the hypothesis of an increased risk of meningioma in patients treated with high doses of cyproterone acetate (CPA). The objective of this study was to test the hypothesis of an increased risk of meningioma among users of high dose CPA as compared with non-users in a medical records computerized database.
  
  
  METHODS
  A retrospective cohort study was performed in a Spanish primary care database (BIFAP). Meningioma incidence rates were compared in patients exposed to high dose CPA (users) with those non-exposed and with those exposed to low dose CPA. Poisson regression analysis was used to estimate the incidence rate ratios after adjusting for age and gender.
  
  
  RESULTS
  Among 2474 users of high dose cyproterone (6663 person-years) four meningioma cases were identified, resulting in an incidence rate (IR) of 60.0 (95% CI 16.4, 153.7) per 100,000 person-years, which was significantly higher than that observed among the non-users (IR 6.6; 95% CI 6.0, 7.3) and among women users of low dose cyproterone (IR 0.0, 95% CI upper limit 5.5). After adjusting for age and gender, patients exposed to high dose CPA showed an increased risk of meningioma of 11.4 (95% CI 4.3, 30.8) as compared with non-users.
  
  
  CONCLUSIONS
  The results of this study support the hypothesis that the exposure to high dose CPA increases the risk of meningioma.
authors.affiliation: Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency for Medicines and Medical Devices, Madrid, Spain. miguel.gil@bifap.org
authors.forename: Miguel
authors.initials: M
authors.lastname: Gil
authors.forename: Belén
authors.initials: B
authors.lastname: Oliva
authors.forename: Julia
authors.initials: J
authors.lastname: Timoner
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Maciá
authors.forename: Verónica
authors.initials: V
authors.lastname: Bryant
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: de Abajo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D015331:Cohort Studies; D017373:Cyproterone Acetate / Q000008:administration & dosage / Q000009:adverse effects*; D016208:Databases, Factual / Q000706:statistics & numerical data; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D016347:Medical Records Systems, Computerized / Q000706:statistics & numerical data; D008579:Meningioma / Q000139:chemically induced* / Q000453:epidemiology; D008875:Middle Aged; D016012:Poisson Distribution; D011320:Primary Health Care; D012044:Regression Analysis; D012189:Retrospective Studies; D012306:Risk; D012737:Sex Factors; D013030:Spain; D013997:Time Factors; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D017373:Cyproterone Acetate