Abstract
Objectives
Hormone therapy (HT) is associated with a modest, but significantly increased risk
for arterial and venous thromboembolism. We have compared the effects of estrogen,
tibolone, and raloxifene on relevant markers of coagulation activation and investigated
whether there is a dose–response relationship of oral HT.
Methods
Randomized, open-label, comparative study of 202 healthy women who were assigned to
receive treatment for 12 weeks with either low-dose hormone therapy containing 1 mg 17β-estradiol + 0.5 mg norethisterone acetate (NETA) (n = 50), conventional-dose HT containing 2 mg 17β-estradiol and 1 mg NETA (n = 50), 2.5 mg tibolone (n = 51), or 60 mg raloxifene (n = 51).
Results
The groups were comparable with regard to demographic characteristics and laboratory
variables at baseline. D-dimer increased markedly in the conventional-dose HT group,
but remained unchanged in the low-dose HT group. Tibolone was associated with a medium
increase, whereas raloxifene was associated with a decrease in D-dimer levels. Changes
in prothrombin fragment 1 + 2 showed a similar pattern for all four groups, whereas no significant differences
in changes of thrombin–antithrombin complex were observed.
Conclusions
Our data suggest that low-dose HT is associated with less activation of coagulation
than conventional-dose HT. This finding may be of clinical importance since randomized
clinical trials showing increased risk of thrombosis have utilized conventional-dose
HT.
Keywords
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Article info
Publication history
Accepted:
April 11,
2006
Received in revised form:
April 4,
2006
Received:
January 30,
2006
Identification
Copyright
© 2006 Elsevier Ireland Ltd. Published by Elsevier Inc. All rights reserved.