The risk of liver disorders in women prescribed cyproterone acetate in combination with ethinyloestradiol (Dianette): a nested case-control study using the GPRD
Article first published online: 6 MAY 2003
Copyright © 2003 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 12, Issue 7, pages 541–550, October/November 2003
How to Cite
Seaman, H. E., de Vries, C. S. and Farmer, R. D. T. (2003), The risk of liver disorders in women prescribed cyproterone acetate in combination with ethinyloestradiol (Dianette): a nested case-control study using the GPRD. Pharmacoepidem. Drug Safe., 12: 541–550. doi: 10.1002/pds.857
- Issue published online: 15 SEP 2003
- Article first published online: 6 MAY 2003
- Manuscript Accepted: 20 MAR 2003
- Manuscript Revised: 11 FEB 2003
- Manuscript Received: 29 OCT 2002
- Schering AG
- cyproterone acetate;
- liver disorders;
- General Practice Research Database
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.
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.
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]).
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. Copyright © 2003 John Wiley & Sons, Ltd.