Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials.

AIM To critically discuss the use of tibolone (T), in light of a series of very recent double-blind placebo (PL) controlled trials (LISA, LIFT, OPAL, THEBES, LIBERATE) conducted worldwide in a large number of postmenopausal women (PMW). METHODS The most relevant publications on T therapy in PMW were considered with emphasis on menopausal symptoms, quality of life, sexuality, bone, cardiovascular system (CVS) and oncologic risk. RESULTS T significantly relieves climacteric symptoms and improves mood and sexual well-being (LISA). T is as effective as estrogen-progestin therapy in preventing bone loss and reducing the relative risk of vertebral and non-vertebral fractures (LIFT). By using surrogate endpoints of the individual risks for the CVS, studies show mixed results, but a favourable effect on acute miocardial infarction and thromboembolism has been documented (THEBES, LIFT, OPAL). Although findings about endometrial and colon cancer are reassuring, conclusive data on breast cancer risk with T are not available and an increased risk of recurrence in women with previous breast cancer emerged (LIBERATE). CONCLUSIONS T is effective in treating menopausal syndrome with a good tolerability profile. In spite of some unsolved issues in term of safety, T is still a good treatment option for early PMW.