Effects of HRT with estradiolvalerate 2-mg + levonorgestrel 75 µg (NUVELLE^®) on clotting and lipid profile

Abstract number: P1235

Falciani M., Beninato L., Bruni V., Checcucci V., Pampaloni F., Cellai A. P., Scarselli G., Abbate R., Fedi S., Bucciantini M. S.

University of Florence, Italy

Alterations of hemostasis and lipid profile may be induced by estro-progestin preparations for HRT but no information is available of a biphasic preparation (estradiolvalerate 2 mg + levonorgestrel 75 µg (NUVELLE^®) on clotting and lipid profile. In this study, the effects of this preparation on Fibrinogen (Fbg), Factor VII (F VII), Factor VIII (F VIII), protein C (PC), protein S (PS), prothrombin fragment 1 + 2 (F1 + 2), activated protein C resistance (APCR), lipoprotein (a) [Lp(a)], homocysteine (Hcy) plasma levels and lipid profile [total cholesterol (tChol), HDL cholesterol (HDL chol) LDL cholesterol (LDL chol) and Triglycerides (TG)] have been investigated in 40 postmenopausal women (mean age 50.7, range 45–59, mean BMI 23.84, range 17.96–37.5, estradiol <30 pg mL^-1 and FSH < 40 IU L^-1) before (T0), after 3 (T1) and 6 (T2) months of treatment. A significant decrease at 6th month of treatment of Fbg (from T0313.3 to T2283.5 mg dL^-1, P < 0.0001), F VII (from T0116.2 to T2105.5%, P = 0.002), PC (from T0124.2 to T2110.2%, P < 0.0001), PS (from T0 94.6 to T2 83.7%, P < 0.001), Hcy (from T0 10.0 <=gmol L^-1 to T2 9.0 <=gmol L^-1, P < 0.001) was observed. A slight increase of F1 + 2 (from T0 0.9 to T2 1.1 nmol L^-1, P < 0.001) and no changes of APCR and F VIII were observed. Concerning the lipid profile, a decrease of TChol (from T0240.2 to T2211.3 mg dL^-1, P < 0.0001) HDL chol (from T0 69.7 to T2 62.8 mg dL^-1, P < 0.0002) LDL chol (from T0146.9 to T2128.9 mg dL^-1, P < 0.0001) and TG (from T0113.3 to T2101.4 mg dL^-1) was found. A significant decrease of Lp(a) (from T0214.4 to T2170.6 mg L^-1, P < 0.0001) was observed in women with Lp(a) plasma levels both higher than 300 mg L^-1 (-23.3% at T2) and/or lower than 300 mg L^-1 (-16.2% at T2). Our results show that this biphasic preparation determines a reduction in the levels of hemostasis-related risk factors associated with an increased risk for cardiovascular disease and moderate changes in blood clotting activation state which remains in the normal range.