Prescription Appropriateness of Cyproterone Acetate/Ethinylestradiol in Primary Care: A Population-Based Study in Italy

Clin Drug Investig. 2017 Aug;37(8):755-762. doi: 10.1007/s40261-017-0529-9.


Background and objective: We evaluated the prescription appropriateness of cyproterone acetate in combination with ethinylestradiol (CPA/EE) in a primary care setting before and after the 2013 European Medicines Agency's (EMA) recommendation relating to the risk profile of CPA/EE.

Methods: Data were obtained from the Health Search IMS Health Longitudinal Patient Database (HSD). We compared the results from 2011 to 2012 with the results of 2014, namely before and after the 2013 EMA recommendation, and investigated the burden of concurrent use of CPA/EE and other hormonal contraceptives (HCs) and the reported indication at the time of CPA/EE prescription.

Results: Overall, 1189 new users of CPA/EE were identified: 495 in 2011, 446 in 2012, and 261 in 2014. Concomitant use of CPA/EE and other HCs was found in 1% of cases in 2011-2012 and 2% of cases in 2014, while potential concomitant use was observed in 4% of cases in 2011 and 2% of cases in 2012 and 2014. A recent (within 365 days) diagnosis of any hyperandrogenic condition was detected in 22 and 24% of CPA/EE users in 2011 and 2012, respectively, and in 24% of cases in 2014. The percentage of CPA/EE users with a recent acne diagnosis and/or treatment was 19, 21, and 18% in 2011, 2012, and 2014, respectively.

Conclusions: Apart from an overall reduction in CPA/EE prescriptions in the HSD, no substantial difference was found in terms of the proportions of patients diagnosed with acne or other hyperandrogenic conditions and/or potential concomitant use of HCs before and after the EMA recommendation.

MeSH terms

  • Acne Vulgaris / drug therapy*
  • Adolescent
  • Adult
  • Cyproterone Acetate / therapeutic use*
  • Drug Combinations
  • Drug Utilization
  • Ethinyl Estradiol / therapeutic use*
  • Female
  • Humans
  • Middle Aged
  • Primary Health Care*
  • Young Adult


  • Drug Combinations
  • Ethinyl Estradiol
  • Cyproterone Acetate
  • Cyproterone acetate, ethinyl estradiol drug combination