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


Reference:

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. Pharmacoepidemiology and Drug Safety, 12 (7), pp. 541-550.

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Official URL:

http://dx.doi.org/10.1002/pds.857

Abstract

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.

Details

Item Type Articles
CreatorsSeaman, H. E., de Vries, C. S. and Farmer, R. D. T.
DOI10.1002/pds.857
DepartmentsFaculty of Science > Pharmacy & Pharmacology
RefereedYes
StatusPublished
ID Code19925

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