Tibolone: new preparation. Menopausal symptoms: oestrogen-progestogen combinations are still the reference treatment.
(1) For symptoms of oestrogen deficiency linked to the menopause, the standard treatment is an oestrogen-progestogen combination. Various dose strengths and formulations are available for continuous or sequential administration. (2) Marketing authorization has been granted in France for continuous tibolone monotherapy (without a progestogen). Tibolone, a synthetic steroid with progestogenic, oestrogenic and androgenic properties, has been available in some countries for more than 10 years. (3) The available clinical file mainly comprises data from trials with a low level of evidence. The largest trial, involving 437 patients, showed no difference in symptom relief between tibolone and continuous oestrogen-progestogen administration. (4) The most frequent short-term side effects of tibolone are irregular bleeding (in approximately 30% of women), oedema, breast tension and nausea. (5) No long-term data on the risk of breast cancer are available, and data on the risks of endometrial cancer are inadequate. The androgenic lipid profile induced by tibolone is unfavourable (reduction in HDL-cholesterol). Tibolone has a positive effect on bone density, but subsequent effects on the risk of fracture have barely been assessed. (6) In practice, tibolone has no particular advantages over oestrogen-progestogen combinations. On the contrary, it bears a poorly assessed risk of severe adverse reactions. Oestrogen-progestogen combinations remain the reference treatment for treating menopausal symptoms.
D045930:Anabolic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000728:Androgens / Q000009:adverse effects / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D004338:Drug Combinations; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000627:therapeutic use; D005260:Female; D005602:France; D006801:Humans; D008593:Menopause / Q000187:drug effects*; D009652:Norpregnenes / Q000009:adverse effects / Q000627:therapeutic use*; D011372:Progestins / Q000627:therapeutic use; D018570:Risk Assessment; D020018:Sexual Dysfunctions, Psychological / Q000188:drug therapy; D016896:Treatment Outcome
D045930:Anabolic Agents; D000728:Androgens; D004338:Drug Combinations; D004967:Estrogens; D009652:Norpregnenes; D011372:Progestins