Effects of either tibolone or continuous combined transdermal estradiol with medroxyprogesterone acetate on coagulatory factors and lipoprotein(a) in menopause

Gynecol Obstet Invest. 2009;68(1):33-9. doi: 10.1159/000211676. Epub 2009 Apr 7.

Abstract

Background/aim: The aim of this prospective controlled study was to compare the effects of two therapies for menopause on factor VII (FVII) and hemostatic variables.

Methods: Postmenopausal women were assigned to receive one of the following treatments: transdermal estradiol (TTS E2; 50 microg) combined in a continuous sequential regimen with oral medroxyprogesterone acetate (MPA; 10 mg/day for 12 days) (group A; n = 20), tibolone (2.5 mg/day) (group B; n = 21) or placebo (group C; n = 19). Sixty women completed the 1-year treatment and underwent follow-up examinations after 3, 6 and 12 months.

Results: TTS E2/MPA induced various changes in procoagulatory factors. At 12 months, fibrinogen, activated FVII (FVIIa) and coagulative FVII (FVIIc) had increased by 10.7, 12.9 and 3.7%, respectively. Among the fibrinolytic factors, plasminogen and alpha2-antiplasmin increased by 11.3 and 7.2%, respectively. Lipoprotein(a) [Lp(a)] and antithrombin III (ATIII) did not show any significant variation. Tibolone induced some changes toward a more homogeneous antithrombotic profile. Fibrinogen, FVIIa and FVIIc decreased significantly by 7.5, 8.1 and 21.3%, respectively. Plasminogen increased (by 11.8%) and Lp(a) decreased (by 28.4%). ATIII was unchanged with tibolone therapy.

Conclusion: Our results show that tibolone induces a significant reduction in FVIIc and Lp(a) and a greater enhancement of factors promoting fibrinolysis than the TTS E2/MPA regimen.

Publication types

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

MeSH terms

  • Administration, Cutaneous
  • Administration, Oral
  • Analysis of Variance
  • Blood Coagulation Factors / drug effects
  • Estradiol / pharmacology*
  • Estradiol / therapeutic use
  • Estrogen Receptor Modulators / pharmacology*
  • Estrogen Receptor Modulators / therapeutic use
  • Estrogen Replacement Therapy / methods*
  • Factor VII / analysis
  • Female
  • Fibrinolysis / drug effects
  • Follow-Up Studies
  • Humans
  • Lipoprotein(a) / analysis
  • Medroxyprogesterone Acetate / pharmacology*
  • Medroxyprogesterone Acetate / therapeutic use
  • Menopause / drug effects*
  • Middle Aged
  • Norpregnenes / pharmacology*
  • Norpregnenes / therapeutic use
  • Postmenopause
  • Prospective Studies

Substances

  • Blood Coagulation Factors
  • Estrogen Receptor Modulators
  • Lipoprotein(a)
  • Norpregnenes
  • Estradiol
  • Factor VII
  • Medroxyprogesterone Acetate
  • tibolone