The risk of liver disorders in women prescribed cyproterone acetate in combination with ethinyloestradiol (Dianette): a nested case-control study using the GPRD.
OBJECTIVE
To explore the risk of liver disorders associated with cyproterone acetate combined with ethinyloestradiol (CPA/EE). CPA/EE is licensed in the UK for the treatment of women with acne and hirsutism and is a treatment option for polycystic ovary syndrome (PCOS). It acts as a contraceptive also.


METHODS
Using the General Practice Research Database, we conducted a cohort analysis and case-control study in women aged 15-39 with acne, hirsutism or PCOS to estimate the risk of liver disorders associated with CPA/EE.


RESULTS
Compared with cases exposed to conventional combined oral contraceptives (COCs), the age-adjusted incidence rate ratio for liver disorders in women using CPA/EE was 1.7 (95% CI: 0.9, 3.4) and compared with no use it was 1.5 (95% CI: 0.8, 2.8). In the case-control study, the adjusted odds ratio (OR) for liver disorders in women exposed to CPA/EE was 1.6 (95% CI: 0.7, 3.5) and 0.8 (95% CI: 0.5, 1.3) for exposure to conventional COCs, compared with no use. The risk of liver disorders in women prescribed CPA/EE was not significantly greater than that in women prescribed conventional COCs (OR: 2.1 [95% CI: 0.9, 4.8]).


CONCLUSIONS
Our results do not indicate an increased risk for liver disorders associated with CPA/EE use in women with acne, hirsutism or PCOS after adjusting for potential confounding. This may be due to lack of statistical power.
Seaman
H E
HE
Department of Pharmacoepidemiology, Postgraduate Medical School (E5), University of Surrey, Stirling House, Surrey Research Park, Guildford, GU2 7DJ, UK. h.seaman@surrey.ac.uk
de Vries
C S
CS
Farmer
R D
RD
D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D015331:Cohort Studies; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage / Q000009:adverse effects*; D017373:Cyproterone Acetate / Q000008:administration & dosage / Q000009:adverse effects*; D019992:Databases as Topic; D004739:England / Q000453:epidemiology; D004997:Ethinyl Estradiol / Q000008:administration & dosage / Q000009:adverse effects*; D005194:Family Practice; D005260:Female; D006801:Humans; D015994:Incidence; D008107:Liver Diseases / Q000453:epidemiology* / Q000209:etiology*; D016017:Odds Ratio; D012307:Risk Factors
D003277:Contraceptives, Oral, Combined; D004997:Ethinyl Estradiol; D017373:Cyproterone Acetate