Tibolone in postmenopausal women: a review based on recent randomised controlled clinical trials.
OBJECTIVE
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.
Biglia
Nicoletta
N
Gynecological Oncology Department, University of Turin, Mauriziano Umberto I Hospital, Turin, Italy.
Maffei
Silvia
S
Lello
Stefano
S
Nappi
Rossella E
RE
D001943:Breast Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D020847:Estrogen Receptor Modulators / Q000009:adverse effects* / Q000627:therapeutic use*; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D005260:Female; D006801:Humans; D009203:Myocardial Infarction / Q000517:prevention & control; D009652:Norpregnenes / Q000009:adverse effects* / Q000627:therapeutic use*; D017698:Postmenopause; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence; D013923:Thromboembolism / Q000517:prevention & control
D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; C027385:tibolone