Abstract
OBJECTIVE To evaluate lipid effects of estradiol/ norgestimate hormone therapy in postmenopausal women with elevated lipid levels. STUDY DESIGN Postmenopausal women were randomized to E2, 1 mg/intermittent norgestimate (NGM) 90 microg (n = 31), or opposed E2, 1 mg (n = 36), in a 12-month trial. A subset analysis was conducted on participants with unfavorable baseline lipid levels, either total cholesterol (TC) levels > 200 mg/dL, high-density lipoprotein cholesterol (HDL-C) levels < 40 mg/dL, low-density lipoprotein cholesterol (LDL-C) levels > or = 160 mg/dL or triglyceride levels > or = 150 mg/dL. Mean changes and categorical shifts were assessed on fasting blood samples collected at baseline and at 7 and 12 months. RESULTS Twelve-month mean changes from baseline in women treated with E2/NGM included a 19.8% increase in HDL-C and decreases of 13.4% in LDL-C, 17.5% in triglycerides and 3.3% in TC. Women with poorer lipid profiles at baseline showed the greatest benefit. Results were similar in women randomized to unopposed E2. CONCLUSION E2/NGM and unopposed E2 were similarly beneficial in modifying lipid fractions in women with unfavorable baseline levels.
