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Effects of Continuous Estrogen and Estrogen-Progestin Replacement Regimens on Cardiovascular Risk Markers in Postmenopausal Women
Michael H. Davidson, MD;
Kevin C. Maki, PhD;
Phyllis Marx, MD;
Ann C. Maki, MS, RD;
Mary Sue Cyrowski, RD;
Nayan Nanavati, MS;
Joan-Carles Arce, MD
Arch Intern Med. 2000;160:3315-3325.
Objective To evaluate the influence of 2 continuous combined estrogen-progestin replacement products, compared with unopposed estrogen and placebo, on cardiovascular risk markers in postmenopausal women in a randomized, double-blind, placebo-controlled trial.
Methods Two hundred seventy healthy postmenopausal women were randomly assigned to 1 of 4 treatment groups: placebo, unopposed 17- estradiol (1 mg), 1 mg of 17- estradiol with 0.25 mg of norethindrone acetate, or 1 mg of 17- estradiol with 0.5 mg of norethindrone acetate. The primary outcome variable was change from baseline in low-density lipoprotein cholesterol concentration. Additional outcome variables included changes in other serum lipid levels, hemostatic variables, and indicators of carbohydrate metabolism.
Results The low-density lipoprotein cholesterol level was reduced to a similar degree in all groups receiving active treatment (10%-14% from baseline; P = .001 for17- estradiol with 0.5 mg of norethindrone acetate, P = .004 for 17- estradiol with 0.25 mg of norethindrone acetate, and P = .001 for 1 mg of 17- estradiol vs placebo). Compared with unopposed 17- estradiol, 17- estradiol with 0.5 mg of norethindrone acetate enhanced the reductions in total cholesterol and apolipoprotein B levels (P<.01 vs 17- estradiol). 17- Estradiol plus norethindrone blunted or reversed the increases in levels of high-density lipoprotein cholesterol, apolipoprotein A-I, and triglycerides produced by 17- estradiol alone. Effects of 17- estradiol plus norethindrone on hemostatic variables were similar to those of 17- estradiol except for factor VII activity, which was significantly reduced with 17- estradiol combined with 0.25 mg (P<.01) and 0.5 mg (P<.05) of norethindrone acetate. 17- Estradiol plus norethindrone appeared to blunt reductions in C-peptide and insulin levels produced by unopposed 17- estradiol but did not elevate these values compared with placebo.
Conclusions 17- Estradiol plus norethindrone produced favorable changes in most cardiovascular risk markers evaluated and has a profile distinct from that of unopposed 17- estradiol. The impact of these differences on cardiovascular events warrants investigation.
From the Chicago Center for Clinical Research, Chicago, Ill (Drs Davidson, Maki, and Marx and Mss Maki and Cyrowski); and Novo Nordisk Pharmaceuticals, Inc, Princeton, NJ (Mr Nanavati and Dr Arce).
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