OBJECTIVE: To determine the effects of tibolone and continuous combined HRT (ccHRT) on parameters in the clotting cascade. DESIGN: Randomized, double-blind study. SETTING:Hemostasis unit of a university hospital clinic in Germany. PATIENT(S): Sixty healthy postmenopausal women. INTERVENTION(S): Twenty-nine subjects were treated with tibolone (2.5 mg/d) and 31 with oral ccHRTcontaining estradiol (2 mg/d) + estriol (1 mg/d) + norethindrone acetate (1 mg/d). MAIN OUTCOME MEASURE(S): Effects on parameters in the clotting cascade at baseline and after 12 and 24 weeks of treatment. RESULT(S): Tibolone increased fibrinolysis parameters without significantly altering coagulation parameters. Treatment with ccHRT resulted in a stimulating effect on parameters of both fibrinolysis and coagulation. Tibolone showed a stronger reduction of factor VII activity; less reduction of AT-III, protein C activity, and protein S activity; stronger increase of the activated partial thromboplastin time, plasminogen and plasminogen-antiplasminogen complexes; and less increase of D-Dimer than ccHRT. Both preparations similarly reduced climacteric complaints, whereas tibolone showed less breast complaints than ccHRT. CONCLUSION(S): This study confirms that tibolone, and to a lesser extent also ccHRT, changes hemostasis parameters toward a more fibrinolytic profile, which may diminish the risk of venous thrombosis.
RCT Entities:
OBJECTIVE: To determine the effects of tibolone and continuous combined HRT (ccHRT) on parameters in the clotting cascade. DESIGN: Randomized, double-blind study. SETTING: Hemostasis unit of a university hospital clinic in Germany. PATIENT(S): Sixty healthy postmenopausal women. INTERVENTION(S): Twenty-nine subjects were treated with tibolone (2.5 mg/d) and 31 with oral ccHRT containing estradiol (2 mg/d) + estriol (1 mg/d) + norethindrone acetate (1 mg/d). MAIN OUTCOME MEASURE(S): Effects on parameters in the clotting cascade at baseline and after 12 and 24 weeks of treatment. RESULT(S): Tibolone increased fibrinolysis parameters without significantly altering coagulation parameters. Treatment with ccHRT resulted in a stimulating effect on parameters of both fibrinolysis and coagulation. Tibolone showed a stronger reduction of factor VII activity; less reduction of AT-III, protein C activity, and protein S activity; stronger increase of the activated partial thromboplastin time, plasminogen and plasminogen-antiplasminogen complexes; and less increase of D-Dimer than ccHRT. Both preparations similarly reduced climacteric complaints, whereas tibolone showed less breast complaints than ccHRT. CONCLUSION(S): This study confirms that tibolone, and to a lesser extent also ccHRT, changes hemostasis parameters toward a more fibrinolytic profile, which may diminish the risk of venous thrombosis.
Authors: Richard J Santen; D Craig Allred; Stacy P Ardoin; David F Archer; Norman Boyd; Glenn D Braunstein; Henry G Burger; Graham A Colditz; Susan R Davis; Marco Gambacciani; Barbara A Gower; Victor W Henderson; Wael N Jarjour; Richard H Karas; Michael Kleerekoper; Roger A Lobo; JoAnn E Manson; Jo Marsden; Kathryn A Martin; Lisa Martin; JoAnn V Pinkerton; David R Rubinow; Helena Teede; Diane M Thiboutot; Wulf H Utian Journal: J Clin Endocrinol Metab Date: 2010-06-21 Impact factor: 5.958