title: Postmenopausal hormone therapy: new questions and the case for new clinical trials.
abstract: Observational studies suggest that postmenopausal hormone therapy (HT) prevents coronary heart disease, whereas randomized clinical trials have not confirmed a cardioprotective effect. Although observational studies may have overestimated the coronary benefit conferred by postmenopausal hormone use, there are other plausible explanations for the apparent discrepancy between previous results and the less favorable findings from clinical trials such as the large Women's Health Initiative. There is now a critical mass of data to support the hypothesis that age or time since menopause may importantly influence the benefit-risk ratio associated with HT, especially with respect to cardiovascular outcomes, and that the method of administration, dose, and formulation of exogenous hormones may also be relevant. Although the weight of the evidence indicates that older women and those with subclinical or overt coronary heart disease should not take HT, estrogen remains the most effective treatment currently available for vasomotor symptoms, and its effects on the development of coronary disease in newly postmenopausal women remain unclear. Moreover, effects of HT on quality of life and cognitive function in recently postmenopausal women merit further study. These unresolved clinical issues provide the rationale for the design of the Kronos Early Estrogen Prevention Study, a 5-year randomized trial that will evaluate the effectiveness of low-dose oral estrogen and transdermal estradiol in preventing progression of atherosclerosis in recently postmenopausal women.
authors.affiliation: Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
authors.forename: Joann E
authors.initials: JE
authors.lastname: Manson
authors.forename: Shari S
authors.initials: SS
authors.lastname: Bassuk
authors.forename: S Mitchell
authors.initials: SM
authors.lastname: Harman
authors.forename: Eliot A
authors.initials: EA
authors.lastname: Brinton
authors.forename: Marcelle I
authors.initials: MI
authors.lastname: Cedars
authors.forename: Rogerio
authors.initials: R
authors.lastname: Lobo
authors.forename: George R
authors.initials: GR
authors.lastname: Merriam
authors.forename: Virginia M
authors.initials: VM
authors.lastname: Miller
authors.forename: Frederick
authors.initials: F
authors.lastname: Naftolin
authors.forename: Nanette
authors.initials: N
authors.lastname: Santoro
mesh_terms: D000279:Administration, Cutaneous; D000375:Aging; D003071:Cognition; D003327:Coronary Disease / Q000453:epidemiology / Q000517:prevention & control; D004958:Estradiol / Q000008:administration & dosage; D015914:Estrogen Replacement Therapy; D004967:Estrogens / Q000008:administration & dosage; D005260:Female; D006801:Humans; D017698:Postmenopause; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D013997:Time Factors; D016387:Women's Health
chemical_list: D004967:Estrogens; D004958:Estradiol