The influence of 5-year therapy with tibolone on the lipid profile in postmenopausal women with mild hypercholesterolemia.

Our objective was to investigate the effects of 5-year therapy with tibolone on the lipid profile in postmenopausal women with mild hypercholesterolemia (total cholesterol, 241 +/- 7 mg/dl; LDL cholesterol, 153 +/- 9 mg/dl). Eighty-two patients were divided into two groups. Group A (53 women) received 2.5 mg of tibolone per day. Group B (29 women) received no tibolone. Total, low- and high-density lipoprotein cholesterol and lipoprotein(a) were found to be decreased in the tibolone group, by 17.7%, 32%, 15.5% and 12%, respectively (p < 0.01) throughout the 5-year treatment, while triglycerides showed no significant change. The lipid profile in the control group remained at its initial values. Menopausal symptoms disappeared in the treatment group within the first 5 months, whereas they deteriorated in the control group during the first 2 years. Although a few unwanted side-effects on hormone-dependent tissues were observed (including vaginal spotting in 11.3% and febrile hemorrhagic cystic mastopathy in 3.8%) long-term therapy with tibolone seemed to be well tolerated, and appeared to have a beneficial effect on the levels of serum lipids.