Pharmacoepidemiol Drug Saf. 2003 Oct-Nov;12(7):541-50

The risk of liver disorders in women prescribed cyproterone acetate in combination with ethinyloestradiol (Dianette): a nested case-control study using the GPRD.

Seaman HE,de Vries CS,Farmer RD.

Department of Pharmacoepidemiology, Postgraduate Medical School (E5), University of Surrey, Stirling House, Surrey Research Park, Guildford, GU2 7DJ, UK. h.seaman@surrey. Ac.uk

Purpose:

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]).

Conclusion:

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.





See Also:

Hirsutism

Alopecia

Do you have an unanswered women's health question?

Please let us have your general question on our NEW FORUM / MESSAGE BOARDS facility and we will try to answer it for you. I am sure that you will appreciate that we cannot offer advice on the management of an individual's specific problem.

Women's Health

Women's Health Forum

Thank you for choosing to visit us.

This is the personal website of David A Viniker MD FRCOG, Consultant Obstetrician and Gynaecologist at Whipps Cross University Hospital, London.

I do hope that you find the answers to your questions in the patient information and medical advice provided. If you still have unanswered questions, please consider entering them into one of our forums and I will try to assist you.

Women's Health