Diane-35 ED also known as Dianette is used fot the treatment of androgen-dependent diseases in women, such as acne, especially pronounced forms and those which are accompanied by seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenetic alopecia and mild forms of hirsutism. Diane-35 is also indicated for oral contraception in women with androgen-dependent diseases and for the treatment of polycystic ovary syndrome.The aim of treatment with Diane 35 is to block the peripheral action of male hormones commonly present in the female body.
When androgen activity is increased in women, conditions such as acne, seborrhea and hirsutism and female pattern baldness can result. These conditions are known as symptoms of androgenization.
Diane-35 ED contains two hormones: cyproterone acetate, a progestogen, and ethinyl estradiol, an estrogen. Cyproterone acetate inhibits the influence of androgens, and reduces the activity of the sebaceous gland which plays an important role in the development of acne and seborrhea.
What’s unique about Diane-35 is its ability to block androgen activity at the pilosebaceous unit. While all oral contraceptives may decrease the production of androgens to some extent, only Diane-35 decreases the ability of androgens to bind to their receptors, improving signs of androgenization such as acne, seborrhea and hirsutism in women.
Because Diane-35 ED contains both an estrogen and progestin, it provides extremely reliable contraception with good cycle control in patients treated for acne, seborrhea and hirsutism. It has many properties in common with other estrogen/progestogen combination oral contraceptives, meaning that the same contraindications and precautions applicable to this class of drugs should be considered."
The recommended duration of treatment is at least several months, as improvement may not be observed until four or five cycles of use. Research has shown that within three to six months of therapy, acne can be improved and suppressed.
It is recommended that a patient continue treatment for another three to four cycles after signs of androgen-related activity have subsided.
Efficacy data from three pivotal clinical trials of Diane-35, including trials in Canada, provides results from 1,462 women with symptoms of androgenization, including severe acne, over a period of 23,549 cycles. In these trials, acne was improved in 38% of patients after three months, and in 91% of patients after 12 months. Improvement was steady with progression of therapy and, by the end of 36 cycles, all cases of facial acne were completely healed.
In these trials, associated symptoms of seborrhea and hirsutism, also showed a similar efficacy profile. By cycle 9, improvement of oily hair and skin was noted in 61% of the women taking Diane-35 ED. While significant improvement in hirsutism was slower to occur, a trend towards improvement was observed consistently throughout the treatment period. After 36 cycles of therapy, hirsutism on the face, chest and abdomen, remitted in 60%, 95% and 82% of the patients respectively.
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