Hormone replacement therapy in perimenopausal women and 2-year change of carotid intima-media thickness.
OBJECTIVE
To assess the 2-year effects of a combined regimen of oral 17beta-estradiol and desogestrel (17betaE-D) and a sequential combination of conjugated equine estrogens and norgestrel (CEE-N) on common carotid intima-media thickness and end-diastolic lumen diameter in comparison to placebo in perimenopausal women.


METHODS
The study was a single center, randomized, group-comparative, double-blind study with respect to the 17betaE-D and placebo groups and open with respect to CEE-N. After cycle 6, the blind was broken and the trial was continued as an open trial for another 18 months for the active study arms. The study included 121 perimenopausal women recruited from the general population. Common carotid intima-media thickness and end-diastolic lumen diameter were measured at baseline and cycle 24 with B-mode ultrasonography.


RESULTS
At cycle 24 small changes in intima-media 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 17betaE-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 17betaE-D and CEE-N, respectively.


CONCLUSIONS
In this study among perimenopausal women a significant effect of 17betaE-D and CEE-N on common carotid intima-media thickness and lumen diameter could not be demonstrated. Although the sample size of the present trial is too limited to provide definite conclusions, the direction of the effect is in agreement with evidence from earlier studies on the effects of hormone replacement therapy in postmenopausal women.
de Kleijn
M J
MJ
Julius Center for Patient Oriented Research, University Medical Center Utrecht, The Netherlands.
Bots
M L
ML
Bak
A A
AA
Westendorp
I C
IC
Planellas
J
J
Coelingh Bennink
H J
HJ
Witteman
J C
JC
Grobbee
D E
DE
D000328:Adult; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging* / Q000473:pathology; D017135:Desogestrel / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004958:Estradiol / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy; D006801:Humans; D008875:Middle Aged; D017697:Premenopause; D013997:Time Factors; D017539:Tunica Intima / Q000473:pathology; D017540:Tunica Media / Q000473:pathology; D014463:Ultrasonography
D004958:Estradiol; D017135:Desogestrel