Effect of two oral doses of 17β-estradiol associated with dydrogesterone on thrombin generation in healthy menopausal women: A randomized double-blind placebo-controlled study

Fundamental and Clinical Pharmacology

Volumn 24, Issue 2, 2010, Pages 239-245

  Rousseau, Alexandra ^a   Robert, Annie ^a   Gerotziafas, Grigoris ^a,b   Torchin, Dahlia ^a   Zannad, Faiez ^c   Lacut, Karine ^d   Libersa, Christian ^e   Dasque, Eric ^a   Démolis, Jean Louis ^a   Elalamy, Ismail ^a,b   Simon, Tabassome ^a  

^a HÔPITAL SAINT ANTOINE   (France)

^b HÔPITAL TENON   (France)

^c UNIVERSITY HOSPITAL OF NANCY   (France)

^d BREST UNIVERSITY HOSPITAL   (France)

^e University of Lille   (France)

Author keywords

Clinical trial; Estrogen; Hormone; Menopause; Therapy; Thrombin; Thrombosis; Venous

Indexed keywords

BLOOD CLOTTING FACTOR 10; BLOOD CLOTTING FACTOR 7; BLOOD CLOTTING FACTOR 8; DYDROGESTERONE; ESTRADIOL; PLACEBO; PROTHROMBIN; THROMBIN; THROMBOPLASTIN;

ARTICLE; BLOOD CLOTTING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; FEMALE; HORMONAL THERAPY; HUMAN; HUMAN EXPERIMENT; MENOPAUSE; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBIN TIME; TREATMENT DURATION;

ADMINISTRATION, ORAL; AGED; BLOOD COAGULATION FACTORS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; DYDROGESTERONE; ESTRADIOL; ESTROGENS; FEMALE; HUMANS; MENOPAUSE; MIDDLE AGED; PROGESTINS; THROMBIN; TIME FACTORS;

EID: 77949879814     PISSN: 07673981     EISSN: 14728206     Source Type: Journal    
DOI: 10.1111/j.1472-8206.2009.00747.x     Document Type: Article

References (30)

1. Cushman M., Kuller L.H., Prentice R. et al. Estrogen plus progestin and risk of venous thrombosis. JAMA (2004) 292 1573 1580.
2. Grady D., Wenger N.K., Herrington D. et al. Postmenopausal hormone therapy increases risk for venous thromboembolic disease. The heart and estrogen/progestin replacement study. Ann. Intern. Med. (2000) 132 689 696.
3. Hoibraaten E., Qvigstad E., Arnesen H., Larsen S., Wickstrom E., Sandset P.M. Increased risk of recurrent venous thromboembolism during hormone replacement therapy - results of the randomized, double-blind, placebo-controlled estrogen in venous thromboembolism trial (EVTET). Thromb. Haemost. (2000) 84 961 967.
4. Hulley S., Grady D., Bush T. et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and estrogen/progestin replacement study (HERS) research group. JAMA (1998) 280 605 613.
5. Rossouw J.E., Anderson G.L., Prentice R.L. et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA (2002) 288 321 333.
6. Pines A., Sturdee D.W., Birkhauser M.H., Schneider H.P., Gambacciani M., Panay N. IMS updated recommendations on postmenopausal hormone therapy. Climacteric (2007) 10 181 194.
7. Stephenson J. FDA orders estrogen safety warnings: agency offers guidance for HRT use. JAMA (2003) 289 537 538.
8. Tchaikovski S.N., van Vliet H.A., Thomassen M.C. et al. Effect of oral contraceptives on thrombin generation measured via calibrated automated thrombography. Thromb. Haemost. (2007) 98 1350 1356.
9. Hemker H.C., Giesen P., Al Dieri R. et al. Calibrated automated thrombin generation measurement in clotting plasma. Pathophysiol. Haemost. Thromb. (2003) 33 4 15.
10. Gerotziafas G.T., Depasse F., Busson J., Leflem L., Elalamy I., Samama M.M. Towards a standardization of thrombin generation assessment: the influence of tissue factor, platelets and phospholipids concentration on the normal values of Thrombogram-Thrombinoscope assay. Thromb. J. (2005) 3 16.
11. Robert A., Aillaud M.F., Eschwege V. et al. Screening for identified and unidentified protein C pathway defects by the Agkistrodon contortrix venom test in consecutive patients. Am. J. Clin. Pathol. (1999) 112 233 237.
12. Hemelaar M., Rosing J., Kenemans P., Thomassen M.C., Braat D.D., van der Mooren M.J. Less effect of intranasal than oral hormone therapy on factors associated with venous thrombosis risk in healthy postmenopausal women. Arterioscler. Thromb. Vasc. Biol. (2006) 26 1660 1666.
13. Koh K.K., Ahn J.Y., Jin D.K. et al. 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) 23 1889 1894.
14. Oger E., Alhenc-Gelas M., Lacut K. et al. Differential effects of oral and transdermal estrogen/progesterone regimens on sensitivity to activated protein C among postmenopausal women: a randomized trial. Arterioscler. Thromb. Vasc. Biol. (2003) 23 1671 1676.
15. Scarabin P.Y., Alhenc-Gelas M., Plu-Bureau G., Taisne P., Agher R., Aiach M. Effects of oral and transdermal estrogen/progesterone regimens on blood coagulation and fibrinolysis in postmenopausal women. A randomized controlled trial. Arterioscler. Thromb. Vasc. Biol. (1997) 17 3071 3078.
16. Teede H.J., McGrath B.P., Smolich J.J. et al. Postmenopausal hormone replacement therapy increases coagulation activity and fibrinolysis. Arterioscler. Thromb. Vasc. Biol. (2000) 20 1404 1409.
17. Caine Y.G., Bauer K.A., Barzegar S. et al. Coagulation activation following estrogen administration to postmenopausal women. Thromb. Haemost. (1992) 68 392 395.
18. Eilertsen A.L., Qvigstad E., Andersen T.O., Sandvik L., Sandset P.M. Conventional-dose hormone therapy (HT) and tibolone, but not low-dose HT and raloxifene, increase markers of activated coagulation. Maturitas. (2006) 55 278 287.
19. Koh K.K., Shin M.S., Sakuma I. et al. Effects of conventional or lower doses of hormone replacement therapy in postmenopausal women. Arterioscler. Thromb. Vasc. Biol. (2004) 24 1516 1521.
20. Dahlback B. Blood coagulation. Lancet (2000) 355 1627 1632.
21. Dielis A.W., Castoldi E., Spronk H.M. et al. Coagulation factors and the protein C system as determinants of thrombin generation in a normal population. J. Thromb. Haemost. (2008) 6 125 131.
22. Butenas S., van't Veer C., Mann K.G. "Normal" thrombin generation. Blood (1999) 94 2169 2178.
23. Gordon E.M., Williams S.R., Frenchek B., Mazur C.A., Speroff L. Dose-dependent effects of postmenopausal estrogen and progestin on antithrombin III and factor XII. J. Lab. Clin. Med. (1988) 111 52 56.
24. Callejon D.R., Franceschini S.A., Montes M.B., Toloi M.R. Hormone replacement therapy and hemostasis: effects in Brazilian postmenopausal women. Maturitas (2005) 52 249 255.
25. Johnson J.V., Lowell J., Badger G.J., Rosing J., Tchaikovski S., Cushman M. Effects of oral and transdermal hormonal contraception on vascular risk markers: a randomized controlled trial. Obstet. Gynecol. (2008) 111 278 284.
26. Sgarabotto M., Baldini M., Dei Cas A. et al. Effects of raloxifene and continuous combined hormone therapy on haemostasis variables: a multicenter, randomized, double-blind study. Thromb. Res. (2007) 119 85 91.
27. Cosman F., Baz-Hecht M., Cushman M. et al. Short-term effects of estrogen, tamoxifen and raloxifene on hemostasis: a randomized-controlled study and review of the literature. Thromb. Res. (2005) 116 1 13.
28. Demirol A., Baykal C., Kirazli S., Ayhan A. Effects of hormone replacement on hemostasis in spontaneous menopause. Menopause (2001) 8 135 140.
29. Post M.S., Rosing J., Van Der Mooren M.J. et al. Increased resistance to activated protein C after short-term oral hormone replacement therapy in healthy post-menopausal women. Br. J. Haematol. (2002) 119 1017 1023.
30. Eilertsen A.L., Liestol S., Mowinckel M.C., Hemker H.C., Sandset P.M. Differential impact of conventional and low-dose oral hormone therapy (HT), tibolone and raloxifene on functionality of the activated protein C system. Thromb. Haemost. (2007) 97 938 943.