Hormone replacement therapy and endothelial function. Results of a randomized controlled trial in healthy postmenopausal women.
OBJECTIVE
To compare the effects of 3 months treatment with tibolone (a single entity synthetic steroid hormone with estrogenic, progestanic and androgenic activities), or continuous combined conjugated equine estrogens (CEE) plus medroxyprogesterone acetate (MPA), with placebo, on endothelial function.


METHODS
A single center, randomized, double-blind, placebo-controlled study.


METHODS
Research center as part of the University Medical Center Utrecht.


METHODS
One hundred and five healthy postmenopausal women, sampled from the general population.


METHODS
Three months treatment with tibolone or CEE+MPA or placebo.


METHODS
At baseline and after 3 months, endothelial function was assessed non-invasively by measuring percent lumen diameter change in the brachial artery after reactive hyperemia and sublingual nitroglycerine spray.


RESULTS
Results are presented as mean differences between treatment groups of endothelium dependent flow mediated dilatation (fmd) and endothelium independent nitroglycerine induced dilatation with 95% confidence intervals (95% CI). After treatment, there was a significant difference in mean fmd between the CEE+MPA group and the placebo group of 2.5% (95% CI: 0.3-4.6) while the tibolone group and the placebo group did not differ significantly (0.6%; 95% CI: 1.6-2.8). Nitroglycerine induced dilatation did not differ significantly between the groups.


CONCLUSIONS
Hormone replacement therapy with CEE+MPA for 3 months increases endothelium dependent fmd of the brachial artery in healthy postmenopausal women. Tibolone did not alter fmd. The clinical significance of this improvement in fmd for cardiovascular disease risk needs to be established.
de Kleijn
M J
MJ
Julius Center for General Practice and Patient Oriented Research, University Medical Center Utrecht, HP D01.335, PO Box 85500, 3508 GA, Utrecht, The Netherlands
Wilmink
H W
HW
Bots
M L
ML
Bak
A A
AA
van der Schouw
Y T
YT
Planellas
J
J
Engelen
S
S
Banga
J D
JD
Grobbee
D E
DE
D000368:Aged; D002318:Cardiovascular Diseases / Q000517:prevention & control; D016001:Confidence Intervals; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004730:Endothelium, Vascular / Q000187:drug effects* / Q000473:pathology; D004966:Estrogens, Conjugated (USP) / Q000627:therapeutic use*; D005260:Female; D020249:Hormone Replacement Therapy / Q000379:methods*; D006801:Humans; D008525:Medroxyprogesterone / Q000627:therapeutic use*; D008875:Middle Aged; D009652:Norpregnenes / Q000627:therapeutic use*; D017698:Postmenopause; D012016:Reference Values
D004966:Estrogens, Conjugated (USP); D009652:Norpregnenes; C027385:tibolone; D008525:Medroxyprogesterone