What is Diane-35?
Diane-35, also known by generic names like co-cyprindiol, is a medication for women of reproductive age. It is composed of two active ingredients: cyproterone acetate and ethinyl estradiol. Cyproterone acetate is a potent anti-androgen, meaning it blocks the effects of male hormones called androgens. Ethinyl estradiol is a synthetic estrogen. This combination of a progestin with strong anti-androgen effects and an estrogen gives Diane-35 its unique pharmacological profile, allowing it to address hormonal imbalances effectively.
How Does Diane-35 Work?
The mechanism of action for Diane-35 is twofold, providing both its therapeutic and contraceptive benefits. The combination of cyproterone acetate and ethinyl estradiol works synergistically to produce these effects.
Anti-androgenic effect
Androgens are male sex hormones that are also present in smaller quantities in women. An excess of androgens or a heightened sensitivity to them can cause conditions like severe acne, oily skin (seborrhoea), and excessive hair growth (hirsutism). The cyproterone acetate in Diane-35 combats this in several ways:
- Blocks receptors: It competitively inhibits androgen receptors in target organs, preventing androgens like testosterone from binding and exerting their effects.
- Reduces androgen synthesis: It suppresses the production of androgens in the ovaries by acting on the hypothalamo-pituitary-ovarian axis.
The ethinyl estradiol component further enhances this anti-androgen effect. It increases the levels of sex hormone-binding globulin (SHBG), a protein that binds to and reduces the amount of free-circulating androgens in the bloodstream.
Contraceptive effect
In addition to its anti-androgen properties, Diane-35 functions as a combined oral contraceptive. The combination of cyproterone acetate and ethinyl estradiol works to prevent pregnancy by:
- Inhibiting ovulation: It suppresses the release of eggs from the ovaries.
- Altering cervical mucus: It changes the consistency of cervical mucus, making it more difficult for sperm to travel to the egg.
- Changing the endometrium: It alters the lining of the uterus, making it less receptive to a fertilized egg.
Approved and Off-Label Uses
Diane-35 is prescribed for specific conditions and should not be used solely for contraception.
- Severe Acne: It is used for moderate to severe acne associated with androgen sensitivity when other treatments, such as topical therapies or systemic antibiotics, have proven ineffective. Clinical studies have shown high success rates in clearing or significantly improving acne within 6 to 12 months.
- Hirsutism: It effectively treats excessive facial and body hair growth in women, with improvements typically seen after several months of treatment.
- Polycystic Ovary Syndrome (PCOS): While not its primary indication, Diane-35 is used to manage hyperandrogenism and irregular menstrual cycles in women with PCOS. It has shown superiority over metformin in reducing androgen levels but is less effective at reducing insulin resistance.
Important Considerations and Risks
Despite its effectiveness, Diane-35 carries significant risks, particularly related to venous thromboembolism (VTE) or blood clots. Regulatory bodies emphasize that its use should be reserved for specific cases where benefits outweigh the risks and that patients should be regularly reviewed by a physician.
Potential Side Effects
Side effects can vary and may include:
- Breast tenderness or swelling
- Headaches or migraines
- Nausea
- Mood changes, including depression
- Weight changes
- Reduced libido
Risk of Venous Thromboembolism (VTE)
The risk of VTE with Diane-35 is a major concern. Observational studies have shown that the risk is 1.5 to 2 times higher than with combined oral contraceptives (COCs) containing levonorgestrel. Key factors that increase this risk include:
- Increasing age
- Smoking
- Obesity
- Prolonged immobility
Patients should be made aware of the signs of blood clots, such as pain and swelling in the legs, or breathlessness and chest pain, and seek immediate medical attention if they occur.
Comparison of Diane-35 with Other Treatments
Choosing the right treatment for hyperandrogenic symptoms involves weighing efficacy against safety risks. Here is a comparison of Diane-35 with some other hormonal therapies:
| Feature | Diane-35 (Ethinyl Estradiol/Cyproterone Acetate) | Yaz/Yasmin (Ethinyl Estradiol/Drospirenone) | Metformin (Non-hormonal) |
|---|---|---|---|
| Primary Use | Severe acne, hirsutism, PCOS symptoms | Acne, PCOS symptoms, water retention | Insulin resistance, PCOS |
| Anti-androgen Strength | Strongest available combined pill | Moderate effects | No anti-androgen effect |
| Contraceptive Effect | High effectiveness | High effectiveness | None |
| Blood Clot Risk | Higher risk than levonorgestrel COCs | Increased risk compared to levonorgestrel COCs | No increased risk |
| Common Side Effects | Headaches, breast tenderness, mood changes | Nausea, breast tenderness, headaches | Gastrointestinal issues (especially early) |
| Insulin Resistance | Can potentially worsen | May improve slightly | Significantly improves insulin sensitivity |
Conclusion
Diane-35 is a highly effective medication for treating severe androgen-related skin conditions like acne and hirsutism in women, as well as managing symptoms of PCOS. Its potent anti-androgen and contraceptive properties stem from the combination of cyproterone acetate and ethinyl estradiol. However, this effectiveness comes with a noted risk profile, particularly an increased risk of venous thromboembolism compared to other combined oral contraceptives. Therefore, it is typically considered a second-line treatment, reserved for patients who have not responded to safer alternatives and must be used under close medical supervision. A thorough discussion of the potential benefits and significant risks with a healthcare provider is essential before starting treatment with Diane-35.
For further information on the benefit-risk balance, consult authoritative health sources like the European Medicines Agency: Benefits of Diane 35 and its generics outweigh risks in certain patient groups.
