Significant differential effects of hormone therapy or tibolone on markers of cardiovascular disease in postmenopausal women: a randomized, double-blind, placebo-controlled, crossover study

Arterioscler Thromb Vasc Biol. 2003 Oct 1;23(10):1889-94. doi: 10.1161/01.ATV.0000091502.96745.95. Epub 2003 Aug 21.

Abstract

Objective: The objective was to compare the effects of tibolone and hormone therapy (HT) on lipid profile, vasodilation, and factors associated with inflammation and hemostasis.

Methods and results: Fifty-three women received micronized progesterone (MP, 100 mg) with conjugated equine estrogen (CEE, 0.625 mg) or tibolone (2.5 mg) daily for 2 months, with a 2-month washout period. Compared with HT, tibolone significantly reduced total cholesterol (P<0.001), triglyceride (P<0.001), and HDL cholesterol (P<0.001) levels as well as triglyceride/HDL cholesterol ratios (P<0.001) but not LDL cholesterol levels. Tibolone significantly improved flow-mediated brachial artery dilator response to hyperemia from baseline values (P<0.001) by a magnitude similar to that found with HT (P=0.628). Compared with tibolone, which showed no changes, HT significantly increased high-sensitivity C-reactive protein (hsCRP, P=0.030) and reduced antithrombin III (P<0.001). HT and tibolone significantly increased prothrombin fragment 1+2 (F1+2) from baseline values (P<0.001 and P=0.004, respectively). The effects of HT and tibolone on hsCRP, antithrombin III, and F1+2 were significantly different. HT and tibolone significantly reduced plasma levels of plasminogen activator inhibitor type 1 antigen from baseline levels (P=0.006 and P=0.005, respectively) to a similar degree (P=0.988).

Conclusions: Tibolone significantly improved flow-mediated brachial artery dilator response by a magnitude similar to that found with CEE+MP; however, tibolone did not significantly change hsCRP and antithrombin III, and tibolone increased F1+2 less than did CEE+MP.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antithrombin III / drug effects
  • Antithrombin III / metabolism
  • Biomarkers / blood
  • C-Reactive Protein / drug effects
  • C-Reactive Protein / metabolism
  • Cardiovascular Diseases / blood
  • Cholesterol / blood
  • Cross-Over Studies
  • Double-Blind Method
  • Estrogen Receptor Modulators / pharmacology*
  • Estrogen Replacement Therapy*
  • Estrogens, Conjugated (USP) / pharmacology
  • Female
  • Humans
  • Medroxyprogesterone Acetate
  • Middle Aged
  • Norpregnenes / pharmacology*
  • Progesterone / pharmacology
  • Triglycerides / blood
  • Vasodilation

Substances

  • Biomarkers
  • Estrogen Receptor Modulators
  • Estrogens, Conjugated (USP)
  • Norpregnenes
  • Triglycerides
  • Progesterone
  • Antithrombin III
  • C-Reactive Protein
  • Cholesterol
  • Medroxyprogesterone Acetate
  • tibolone