Hormone replacement therapy in perimenopausal women and 2-year change of carotid intima-media thickness

Objectives: To assess the 2-year effects of a combined regimen of oral 17 b eta-estradiol and desogestrel (17 beta E-D) and a sequential combination of conjugated equine estrogens and norgestrel (CEE-N) on common carotid intim a-media thickness and end-diastolic lumen diameter in comparison to placebo in perimenopausal women. Methods: The study was a single center, randomize d, group-comparative, double-blind study with respect to the 17 beta E-D an d placebo groups and open with respect to CEE-N. After cycle 6, the blind w as broken and the trial was continued as an open trial for another 18 month s for the active study arms. The study included 121 perimenopausal women re cruited from the general population. Common carotid intima-media thickness and end-diastolic lumen diameter were measured at baseline and cycle 24 wit h B-mode ultrasonography. Results: At cycle 24 small changes in intima-medi a thickness and lumen diameter were observed. Relative to placebo, changes in intima-media thickness were - 0.009 mm [95% CI - 0.045; 0.027] for 17 be ta E-D and - 0.016 mm [95% CI - 0.055; 0.024] for CEE-N. For end-diastolic lumen diameter the changes were - 0.091 mm [95% CI - 0.236; 0.055] and - 0. 125 mm [95% CI - 0.820; 0.032] for 17 beta E-D and CEE-N, respectively. Con clusions: In this study among perimenopausal women a significant effect of 17 beta E-D and CEE-N on common carotid intima-media thickness and lumen di ameter could not be demonstrated. Although the sample size of the present t rial is too limited to provide definite conclusions, the direction of the e ffect is in agreement with evidence from earlier studies on the effects of hormone replacement therapy in postmenopausal women. (C) 1999 Elsevier Scie nce Ireland Ltd. All rights reserved.