European Heart Journal Advance Access originally published online on May 4, 2005
European Heart Journal 2005 26(14):1362-1368; doi:10.1093/eurheartj/ehi311
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Significant differential effects of lower doses of hormone therapy or tibolone on markers of cardiovascular disease in post-menopausal women: a randomized, double-blind, crossover study
1Division of Cardiology, Gil Heart Center, Gachon Medical School, 1198 Kuwol-dong, Namdong-gu, Incheon 405-760, Korea
2Department of Laboratory Medicine, Gil Heart Center, Gachon Medical School, Incheon, Korea
3Department of Statistics, Ewha Womans University, Seoul, Korea
Received 27 January 2005; revised 26 March 2005; accepted 7 April 2005; online publish-ahead-of-print 4 May 2005.
* Corresponding author. Tel: +82 32 460 3683; fax: +82 32 460 3117. E-mail address: kwangk{at}ghil.com
See page 1345 for the editorial comment on this article (doi:10.1093/eurheartj/ehi354)
Aims We have previously reported that lower doses of hormone therapy (L-HT) and tibolone have different effects on markers of cardiovascular disease when compared with conventional doses of HT. The objective was to compare the effects of L-HT and tibolone on lipid profile, vasodilation, and factors associated with inflammation and haemostasis.
Methods and results Forty-one women received a combination of micronized progesterone 100 mg with conjugated equine estrogen 0.3 mg vs. tibolone 2.5 mg alone daily in random order during 2 months with 2 months washout period. When compared with L-HT, tibolone significantly reduced total cholesterol (P<0.001), triglyceride (P<0.001), HDL cholesterol (P<0.001) levels, and triglyceride/HDL cholesterol ratios (P=0.004) except total cholesterol/HDL cholesterol ratios. Tibolone improved flow-mediated response to hyperaemia from baseline values (P<0.001) by a similar magnitude to L-HT. L-HT and tibolone did not increase high-sensitivity C-reactive protein relative to baseline values. L-HT reduced antithrombin III from baseline values (P=0.037), compared with tibolone showing no changes. However, there was no difference between either. In contrast, tibolone increased pro-thrombin fragment 1+2 (F1+2) from baseline values (P=0.002), compared with L-HT showing no changes. Tibolone significantly reduced plasma plasminogen activator inhibitor type 1 (PAI-1) antigen levels from baseline values (P=0.004), compared with L-HT showing no changes. The effects of L-HT and tibolone on F1+2 and PAI-1 were significantly different (P=0.045 and P=0.008, respectively).
Conclusion Both tibolone and L-HT improved flow-mediated response by a similar magnitude and did not significantly increase high-sensitivity C-reactive protein. However, tibolone significantly reduced PAI-1, but increased F1+2 more than L-HT.
Key Words: Hormone therapy • Lower doses • Tibolone • Endothelial function • Inflammation • Haemostasis
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