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Should we limit the use of Dianette?

Q - Is there any good evidence to support limiting the duration of the prescribing of Dianette?

A - Dianette contains 35µg ethinylestradiol and 2mg cyproterone acetate. Indications for Dianette are severe acne that has failed to respond to oral antibiotics, and moderately severe hirsutism, due to its oestrogen-dominant and anti-androgenic effects.

It is also an effective low-dose combined oral contraceptive, although it is only licensed for this purpose when used primarily for its medical indication.

There is some epidemiological evidence the incidence of venous thromboembolism (VTE) in users of Dianette is higher than in users of low-dose COCs.

A recent case-control study using the UK General Practice Research Database found a four-fold increase in the risk of VTE in women taking COCs containing cyproterone acetate versus COCs containing levonorgestrel.

Further, some concerns have been raised on hepatic effects associated with long-term use of high doses of cyproterone acetate (mostly based on animal work).

The CSM recommends women should discontinue Dianette three to four cycles after the acne/hirsutism has resolved. This is usually after one to three years.

If acne recurs or the alternatives fail, then either Yasmin or repeated courses of Dianette may be given. Otherwise, continued use of Dianette on a named-patient basis as therapy for acne or hirsutism could be justified on the basis of benefit due to its therapeutic effect balancing any increased risks associated with continued use.

Dr Anne MacGregor is a medical adviser for the Margaret Pyke Memorial Trust, London

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