OBJECTIVE: To investigate the effects of combined hormone replacement therapy (HRT) on various parameters of coagulation and fibrinolysis that may contribute to increased risk for venous thromboembolic events. DESIGN: Prospective, randomized, double-blind, placebo-controlled study. SETTING: Academic hospital. PATIENT(S): Sixty-one healthy postmenopausal women with intact uterus. INTERVENTION(S): Patients were randomized to receive continuous combined HRT (estradiol, 2 mg/d, and norethisterone acetate, 1 mg/d) or placebo for 6 months. MAIN OUTCOME MEASURE(S): Markers of coagulation and fibrinolysis were measured before therapy and after 3 and 6 months of therapy. RESULT(S): The groups did not differ significantly in levels of prothrombin fragments 1 and 2 and thrombin-antithrombin III complex after 3 and 6 months of therapy. After 6 months of HRT, significant decreases in activity of antithrombin III and protein C and levels of plasminogen activator inhibitor-1 antigen, tissue-type plasminogen activator antigen, and euglobulin clot lysis time and a significant increase in D-dimer level were found compared with placebo. CONCLUSION(S): Continuous combined HRT for several months produced no net activation of coagulation but improved fibrinolysis in healthy postmenopausal women with no risk factors for venous thromboembolic events.
RCT Entities:
OBJECTIVE: To investigate the effects of combined hormone replacement therapy (HRT) on various parameters of coagulation and fibrinolysis that may contribute to increased risk for venous thromboembolic events. DESIGN: Prospective, randomized, double-blind, placebo-controlled study. SETTING: Academic hospital. PATIENT(S): Sixty-one healthy postmenopausal women with intact uterus. INTERVENTION(S): Patients were randomized to receive continuous combined HRT (estradiol, 2 mg/d, and norethisterone acetate, 1 mg/d) or placebo for 6 months. MAIN OUTCOME MEASURE(S): Markers of coagulation and fibrinolysis were measured before therapy and after 3 and 6 months of therapy. RESULT(S): The groups did not differ significantly in levels of prothrombin fragments 1 and 2 and thrombin-antithrombin III complex after 3 and 6 months of therapy. After 6 months of HRT, significant decreases in activity of antithrombin III and protein C and levels of plasminogen activator inhibitor-1 antigen, tissue-type plasminogen activator antigen, and euglobulin clot lysis time and a significant increase in D-dimer level were found compared with placebo. CONCLUSION(S): Continuous combined HRT for several months produced no net activation of coagulation but improved fibrinolysis in healthy postmenopausal women with no risk factors for venous thromboembolic events.
Authors: Daniela Amorim Melgaço Guimarães; Maria das Graças Carvalho; Jarbas Cardoso; Marinez de Oliveira Sousa; Romerson Martins Franco; Hilton de Almeida Franco; Túlio César Alvim; George da Silva Teixeira; Luci Maria SantAna Dusse; Ana Paula Fernandes Journal: J Thromb Thrombolysis Date: 2007-12-04 Impact factor: 2.300