Published Online
on September 30, 2004

A more recent version of this article appeared on November 1, 2004

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Submitted on July 12, 2004
Accepted on August 5, 2004

Hormone Replacement Therapy and Stroke. Clinical Trials Review

Lawrence M. Brass MD^*

From the Departments of Neurology and Epidemiology and Public Health, Yale University School of Medicine, New Haven, Conn; and the Neurology Service of the Veterans Administration Connecticut Healthcare System, West Haven, Conn.

^* To whom correspondence should be addressed. E-mail: lawrence.brass{at}yale.edu.

Abstract--Bench research suggests that postmenopausal hormonal therapy is associated with beneficial effects on the brain and vascular system. Observational data suggest that postmenopausal hormone replacement therapy is associated with a 25% to 50% lower rate of cardiovascular disease; however, observational data for hormonal therapy is associated with the potential for significant biases. Clinical trial data are needed. There are 3 major clinical trials that inform us about stroke and postmenopausal hormone replacement therapy. Two trials focused on secondary prevention: the Heart and Estrogen/progesterone Replacement Study (HERS) and the Women’s Estrogen for Stroke Trial (WEST). One examined primary prevention: the Women’s Health Initiative (WHI). All indicate that postmenopausal hormone therapy is not effective for reducing the risk of a recurrent stroke or death among women with established vascular disease or for prevention of a first stroke. Similar results exist for cardiovascular disease. The results of these trials are now reflected in national guidelines. Hormone therapy should not be initiated to prevent vascular disease among postmenopausal women. As a result of these trials, the portion of postmenopausal women using hormone replacement therapy in the United States has fallen by more than half over the past decade.

Key words: clinical trials • estrogen • hormone replacement therapy • prevention • stroke

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