Impact of estetrol (E4) on hemostasis, metabolism and bone turnover in postmenopausal women.

Autor: Douxfils J; Department of Pharmacy, Namur Thrombosis and Hemostasis Center, University of Namur, Namur, Belgium.; QUALIblood s.a, Namur, Belgium., Gaspard U; Department of Obstetrics and Gynecology, University of Liège, Liège, Belgium., Taziaux M; Estetra SRL, an affiliate company of Mithra Pharmaceuticals, Liège, Belgium., Jost M; Estetra SRL, an affiliate company of Mithra Pharmaceuticals, Liège, Belgium., Bouvy C; QUALIblood s.a, Namur, Belgium., Lobo RA; Department of Obstetrics and Gynecology, Columbia University Irving Medical Center, New York, NY, USA., Utian WH; Case Western Reserve Medical School, Cleveland, OH, USA., Foidart JM; Department of Obstetrics and Gynecology, University of Liège, Liège, Belgium.; Estetra SRL, an affiliate company of Mithra Pharmaceuticals, Liège, Belgium.
Jazyk: angličtina
Zdroj: Climacteric : the journal of the International Menopause Society [Climacteric] 2023 Feb; Vol. 26 (1), pp. 55-63. Date of Electronic Publication: 2022 Nov 18.
DOI: 10.1080/13697137.2022.2139599
Abstrakt: Objective: This study aimed to determine the effects of estetrol (E4) on hemostasis, lipids, carbohydrate metabolism and bone turnover in postmenopausal women.
Methods: This study was a multicenter, randomized, double-blind placebo-controlled phase 2 trial. Participants ( n  = 180, age 43-64 years) received E4 2.5 mg, 5 mg, 10 mg and 15 mg or placebo once daily for 12 weeks. Changes from baseline at week 12 were evaluated versus placebo for hemostasis parameters, sex hormone binding globulin (SHBG), lipids, carbohydrate metabolism and bone markers.
Results: Changes for hemostasis parameters were minimal with a small increase only in the normalized activated protein C sensitivity ratio in the E4 15 mg group versus placebo. SHBG increased in the E4 5 mg, 10 mg and 15 mg groups versus placebo. High-density lipoprotein cholesterol increased in all E4 groups; changes were not consistent for other lipids. Significant decreases versus placebo were seen for insulin resistance (E4 10 mg group), hemoglobin A1c (E4 15 mg group) and type 1 collagen C-terminal telopeptide (E4 10 mg and 15 mg groups). Small decreases in osteocalcin in the E4 5 mg, 10 mg and 15 mg groups were significant versus the increase observed in placebo.
Conclusion: E4 had limited impact on hemostasis and potentially beneficial effects on lipids, carbohydrate metabolism and bone turnover.
Databáze: MEDLINE
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