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


CONCLUSIONS
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.
Department of Gynecology and Obstetrics, University Sapienza, Rome, Italy. giuseppina.perrone@uniroma1.it
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D000279:Administration, Cutaneous; D000284:Administration, Oral; D000704:Analysis of Variance; D001779:Blood Coagulation Factors / Q000187:drug effects; D004958:Estradiol / Q000494:pharmacology* / Q000627:therapeutic use; D020847:Estrogen Receptor Modulators / Q000494:pharmacology* / Q000627:therapeutic use; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005167:Factor VII / Q000032:analysis; D005260:Female; D005342:Fibrinolysis / Q000187:drug effects; D005500:Follow-Up Studies; D006801:Humans; D017270:Lipoprotein(a) / Q000032:analysis; D017258:Medroxyprogesterone Acetate / Q000494:pharmacology* / Q000627:therapeutic use; D008593:Menopause / Q000187:drug effects*; D008875:Middle Aged; D009652:Norpregnenes / Q000494:pharmacology* / Q000627:therapeutic use; D017698:Postmenopause; D011446:Prospective Studies
D001779:Blood Coagulation Factors; D020847:Estrogen Receptor Modulators; D017270:Lipoprotein(a); D009652:Norpregnenes; D004958:Estradiol; D005167:Factor VII; D017258:Medroxyprogesterone Acetate; C027385:tibolone