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No Long-Term Primary-Prevention Benefit with Combination HRT

Combination hormone replacement therapy should not be initiated or continued long-term for the primary prevention of coronary heart disease.

Results from the HERS II study (JW Cardiology Aug 23 2002) show that hormone replacement therapy (HRT) should not be used for secondary prevention of adverse heart events in postmenopausal women with coronary heart disease (CHD). But what about for primary prevention in healthy women? The Women's Health Initiative (WHI), a series of trials involving 161,809 postmenopausal women, includes a randomized, placebo-controlled trial of combination HRT use (estrogen plus progestin) in 16,608 women (age range, 50-79) without CHD and with a uterus.

After 5.2 of the planned 8.5 years of follow-up, the trial was halted because the data revealed an increased risk for invasive breast cancer, CHD events (nonfatal MI or CHD death), stroke, and pulmonary embolism (PE) among actively treated women. All-cause mortality rates did not differ between groups, and colorectal cancer and hip-fracture rates were found to be lower with active treatment than with placebo.

Comment: In view of the substantial risk for CHD events, stroke, PE, and breast cancer associated with long-term HRT, combination therapy with estrogen plus progestin should not be initiated or continued long-term for the primary prevention of CHD. Along with the results from HERS II and from other studies, these data are part of a large body of evidence showing that HRT is associated with significantly increased cardiovascular risk in postmenopausal women with and without CHD. Combination HRT should no longer be viewed as a therapy to prevent heart disease. Expected in 2005 are results from an arm of WHI comparing estrogen alone with placebo; that arm has not been halted.

— JoAnne M. Foody, MD

Published in Journal Watch Cardiology August 23, 2002

Citation(s):

Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002 Jul 17; 288:321-33.

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