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June 9, 1997

A Comparison of Estrogen Replacement, Pravastatin, and Combined Treatment for the Management of Hypercholesterolemia in Postmenopausal Women

Author Affiliations

From the Chicago Center for Clinical Research, Chicago, Ill (Dr Davidson, Mss Testolin and Drennan, and Mr Maki), and the Department of Health, Physical Education, and Recreation, University of North Dakota, Grand Forks (Dr von Duvillard).

Arch Intern Med. 1997;157(11):1186-1192. doi:10.1001/archinte.1997.00440320068007

Objectives:  To evaluate and compare the lipid-altering effects of conjugated estrogens and pravastatin, alone and in combination, in postmenopausal women with hypercholesterolemia.

Methods:  This was a double-blind, randomized, placebo-controlled clinical trial with 4 parallel groups. Participants (N=76) were randomly assigned to receive conjugated estrogens, 0.625 mg/d; pravastatin sodium, 20 mg/d; conjugated estrogens plus pravastatin; or a placebo for 16 weeks.

Results:  Primary end points were changes in serum lipid parameters. Among participants treated with conjugated estrogens, levels of non-high density lipoprotein cholesterol (non-HDL-C) (13.0%) and calculated low density lipoprotein cholesterol (LDL-C) (13.5%) decreased, while levels of HDL-C (22.5%) and triglycerides (4.2%) increased. Participants in the pravastatin group achieved reductions of 23.7% and 25.4% in non— HDL-C and calculated LDL-C levels, respectively. Levels of HDL-C increased slightly (3.7%) and triglycerides decreased by 12.1%. Among participants treated with a combination of conjugated estrogens plus pravastatin, the non—HDL-C (—25.2%) and calculated LDL-C (—28.7%) responses were similar to those of the pravastatin group, and the HDL-C response (21.2%) was similar to that observed in the conjugated estrogens group. Triglyceride levels remained similar to baseline ( —0.9%) in the combined treatment group.

Conclusions:  Administration of conjugated estrogens resulted in potentially antiatherogenic changes in levels of non-HDL-C, HDL-C, and calculated LDL-C. The HDL-C response to combined treatment was similar to that observed in women taking conjugated estrogens alone, while the non-HDL-C and LDL-C responses to combined treatment were similar to those produced by pravastatin therapy alone. These findings support the position of the National Cholesterol Education Program that estrogen replacement, with a progestin where indicated, should be given consideration as a therapeutic option for the management of hypercholesterolemia in postmenopausal women.Arch Intern Med. 1997;157:1186-1192