TY - JOUR
T1 - Effect of tamoxifen on measurements of hemostasis in healthy women
AU - Mannucci, P. M.
AU - Bettega, D.
AU - Chantarangkul, V.
AU - Tripodi, A.
AU - Sacchini, V.
AU - Veronesi, U.
PY - 1996/9/9
Y1 - 1996/9/9
N2 - Background: Tamoxifen citrate is being evaluated for primary prevention of breast cancer, but this drug with estrogenlike properties may cause changes in the hemostatic system that would increase the risk of thrombosis. Methods: Women who had undergone hysterectomy were consecutively enrolled in the placebo-controlled, randomized, double-blind Breast Carcinoma Chemoprevention Tamoxifen Study, which was designed to evaluate the efficacy of oral tamoxifen citrate (20 mg/d). Our substudy of hemostasis and lipid measurements included the first 68 consecutive women assigned to tamoxifen (n = 31) or placebo (n = 37). Blood specimens were obtained before treatment and after 1, 2, 4, and 6 months of treatment. Measurements included blood cell counts, lipid levels, coagulation activation markers, clotting factors, and anticoagulant and fibrinolysis proteins. Results: Hematocrit and hemoglobin and platelet levels fell slightly but significantly in women treated with tamoxifen. No between-treatment differences were observed in any of the clotting factors. Naturally occurring anticoagulant proteins such as antithrombin and protein C fell slightly in women treated with tamoxifen. However, no significant changes were observed in any of the markers of activated coagulation or fibrinolysis (fibrinopeptide A, prothrombin fragment 1 + 2, thrombin-antithrombin complex, D-dimer). Total and low-density lipoprotein cholesterol levels fell significantly in women treated with tamoxifen. Conclusions: Tamoxifen induced a modest decrease in anticoagulant proteins, but without biochemical signs of activation of coagulation and fibrinolysis. Tamoxifen improved the lipid profile and induced changes in blood cell counts, which should determine an improvement in blood rheologic factors. These preliminary findings seem to justify continuation of the double-blind study in healthy women, but only direct comparison of thromboembolic complications in the 2 treatment groups will establish whether tamoxifen carries a risk of thrombosis.
AB - Background: Tamoxifen citrate is being evaluated for primary prevention of breast cancer, but this drug with estrogenlike properties may cause changes in the hemostatic system that would increase the risk of thrombosis. Methods: Women who had undergone hysterectomy were consecutively enrolled in the placebo-controlled, randomized, double-blind Breast Carcinoma Chemoprevention Tamoxifen Study, which was designed to evaluate the efficacy of oral tamoxifen citrate (20 mg/d). Our substudy of hemostasis and lipid measurements included the first 68 consecutive women assigned to tamoxifen (n = 31) or placebo (n = 37). Blood specimens were obtained before treatment and after 1, 2, 4, and 6 months of treatment. Measurements included blood cell counts, lipid levels, coagulation activation markers, clotting factors, and anticoagulant and fibrinolysis proteins. Results: Hematocrit and hemoglobin and platelet levels fell slightly but significantly in women treated with tamoxifen. No between-treatment differences were observed in any of the clotting factors. Naturally occurring anticoagulant proteins such as antithrombin and protein C fell slightly in women treated with tamoxifen. However, no significant changes were observed in any of the markers of activated coagulation or fibrinolysis (fibrinopeptide A, prothrombin fragment 1 + 2, thrombin-antithrombin complex, D-dimer). Total and low-density lipoprotein cholesterol levels fell significantly in women treated with tamoxifen. Conclusions: Tamoxifen induced a modest decrease in anticoagulant proteins, but without biochemical signs of activation of coagulation and fibrinolysis. Tamoxifen improved the lipid profile and induced changes in blood cell counts, which should determine an improvement in blood rheologic factors. These preliminary findings seem to justify continuation of the double-blind study in healthy women, but only direct comparison of thromboembolic complications in the 2 treatment groups will establish whether tamoxifen carries a risk of thrombosis.
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U2 - 10.1001/archinte.156.16.1806
DO - 10.1001/archinte.156.16.1806
M3 - Article
C2 - 8790074
AN - SCOPUS:0029791115
VL - 156
SP - 1806
EP - 1810
JO - Archives of Internal Medicine
JF - Archives of Internal Medicine
SN - 0003-9926
IS - 16
ER -