Diane-35: Dosing, Efficacy, Compliance and Cost

March 2, 2007

Dosing

Diane-35® is sold in blister pack units containing 21 tablets
Each tablet contains 2mg of cyproterone acetate and 0.035mg of ethinyl estradiol. Each cycle consists of 21 days on the medication and a 7-day interval without it.
The first treatment course begins on the first day of the woman’s menstrual cycle
Treatment should be continued for several months, since it usually takes at least four cycles to see an improvement in acne. After symptoms have subsided, patients should continue treatment for at least an additional three to four cycles.

Improvements in seborrhea are generally seen after 2 to 3 months.
Improvements to acne are generally seen after 3 to 4 months.
Numerous studies have proven the efficacy of hormonal therapy in treating acne over 6 or more months of use.
Many studies demonstrated the efficacy of Diane-35 in acne over the last 20 years: The Aydinlik trial that included 1161 patients followed for 3 years showed facial acne significantly improved or healed in 72%, 91% and 100% after 6, 12 and 36 months of treatment.
In a comparative trial with Minovral (levonorgestrel 150ug/EE 30ug), Diane had a 70% reduction of acne after 6 cycles compared to 35% for the levonorgestrel preparation.
Another study comparing Diane-35 and Marvelon (desogestrel 150ug/EE 30ug) over a period of 9 months found acne to improved by 81% with Diane-35 and 63% with Marvelon.
Greenwood compared the reduction of lesion between Diane-35 and tetracycline. Results were 74% for Diane-35 and 68% for tetracycline.
In the small number of women with severe hyperandrogenism and in whom progress is poor after 3 to 6 months of Diane-35® alone, additional cyproterone acetate of 12.5 to100 mg/day may be given on days 5-14 of the menstrual cycle. This is not commonly done for acne control.

Side effects of these higher doses include:
- fatigue
- depression
- reduced libido
- weight gain
- breast tenderness
- worsening of the lipid profile.

Patients should take Diane-35® at the same time each day with liquid.
Both constituents of Diane-35® (cyproterone acetate and ethinyl estradiol) are completely absorbed when taken orally.

Diane-35 is sold to pharmacy wholesalers at a cost of $19.00 per cycle.
The cost for the patient will vary a lot depending on the point of purchase (all chains sell the product at a different price) and the province (different coverage and pharmacist dispensing fees).