Abstract
This study aimed at investigating changes in postmenopausal women's cardiovascular risk markers induced by hormone therapy regimens of low (1.0 mg) or ultra-low (0.5 mg) doses of micronized estradiol (mE(2)) and levonorgestrel (LNG). Three randomized placebo-controlled trials were reanalyzed with regard to changes in cardiovascular risk markers, such as serum lipids, lipoproteins, and coagulation parameters. Trial 1 (n = 210) was an 8-week study comparing the effects of 1.0 or 0.5 mg of unopposed mE(2) on menopausal symptoms. Trial 2 (n = 194) was a 24-week study comparing the effects of 1.0 mg of mE(2) combined with 10, 20, or 40 μg of LNG on endometrial safety. Trial 3 (n = 195) was a 52-week study comparing the effects of 1.0 or 0.5 mg mE(2) + 40 μg LNG on bone metabolism. 1.0 mg of unopposed mE(2) reduced low-density lipoprotein cholesterol (LDL-C) after as little as 8 weeks. 1.0 mg mE(2) for 24 weeks lowered the serum levels of total cholesterol (TC) and LDL-C, whereas the addition of LNG caused decreases in the levels of high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) in a dose-dependent fashion. 1.0 or 0.5 mg mE(2) + 40 μg LNG for 52 weeks also lowered the levels of TC, HDL-C, LDL-C, and TG. Both regimens slightly lowered antithrombin and Protein C activities within normal limits. Hormone therapy using 1.0 or 0.5 mg of mE(2) and LNG lowers the serum levels of TC, HDL-C, LDL-C, and TG without significantly affecting coagulation/fibrinolysis parameters.
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