Long-term effects of tibolone on circulating levels of vascular cell adhesion molecules and E-selectin in postmenopausal women.
OBJECTIVE
Adherence of lymphocytes and monocytes to cell adhesion molecules (vascular cell adhesion molecules [VCAMs]) expressed by activated endothelial cells is the first step in the development of atherosclerotic disease. It is known that administration of tibolone for 8 weeks reduces serum levels of VCAMs in postmenopausal women. We evaluated the effects of the administration of tibolone in postmenopausal women for 1 year.


METHODS
Randomized, placebo-controlled, crossover trial.


METHODS
Healthy volunteers in an academic environment.


METHODS
Thirty-six healthy women in postmenopause since 1-4 years.


METHODS
Group A received 2.5 mg/d of tibolone and group B received placebo for 12 months; treatment was subsequently crossed over for 1 month.


METHODS
Serum concentrations of VCAM-1, intercellular adhesion molecule-1 (ICAM-1), and E-selectin were evaluated at baseline and at 6, 12, and 13 months.


RESULTS
Baseline concentration of VCAM-1, ICAM-1, and E-selectin were similar in both groups. At months 6 and 12, mean concentrations of VCAM-1, ICAM-1, and E-selectin decreased significantly in group A but not in group B. At month 13, levels returned to baseline in group A, whereas they decreased significantly in group B.


CONCLUSIONS
Tibolone causes a rapid and sustained decrease in circulating levels of VCAMs; the effect is lost soon after stopping the treatment. Tibolone induces favorable changes in endothelial function and may exert a direct cardiovascular protective effect in postmenopausal women.
Cicinelli
Ettore
E
Department of Obstetrics and Gynecology, Section of Internal Medicine, University of Bari, Bari, Italy. Cicinelli@gynecology1.uniba.it
Ranieri
Giuseppe
G
Maffei
Silvia
S
Colafiglio
Giuseppe
G
Ria
Roberto
R
Bellavia
Marina
M
Schonauer
Matteo M
MM
D018592:Cross-Over Studies; D019040:E-Selectin / Q000097:blood*; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D009652:Norpregnenes / Q000008:administration & dosage*; D015990:Placebo Effect; D017698:Postmenopause / Q000097:blood* / Q000187:drug effects*; D019010:Vascular Cell Adhesion Molecule-1 / Q000097:blood*
D019040:E-Selectin; D020847:Estrogen Receptor Modulators; D009652:Norpregnenes; D019010:Vascular Cell Adhesion Molecule-1; C027385:tibolone