NEWS

UNC study tests estrogen alternative for women after menopause

By LESLIE H. LANG
UNC School of Medicine

CHAPEL HILL -- Researchers at the University of North Carolina at Chapel Hill studying an alternative to traditional hormone replacement therapy for postmenopausal women are seeking volunteers to participate.

The researchers seek to determine if the drug raloxifene (Evista), which is neither a hormone nor an estrogen, has cardiovascular benefits for postmenopausal women with elevated or borderline high blood pressure.

Raloxifene is a selective estrogen receptor modulator. U.S. Food and Drug Administration approved since 1997, it has been shown to reduce menopausal symptoms and to improve bone density and cholesterol levels.

Unlike estrogen, however, raloxifene is not associated with an increase in cancer risk.

"In our previous research, we have observed a lowering of blood pressure in women who have elevated blood pressure prior to starting estrogen replacement," said study principal investigator Dr. Kimberly Brownley, assistant professor of psychiatry and member of the department’s Stress and Health Research Program. "We would like to find out if raloxifene also lowers blood pressure, and if so, does it accomplish this by improving hormonal and metabolic functioning."

Studies have shown that raloxifene, like estrogen, can help improve bone density and blood lipid profiles, but it doesn’t appear to have the same magnitude of effect, Brownley added.

"Like estrogen, it reduces levels of ‘bad cholesterol,’ LDL, but doesn’t improve HDL, the ‘good cholesterol.’ Our second objective is to see if the addition of exercise while taking raloxifene can make up some of those magnitude differences."

Women enrolled in the Cardiovascular Health After Menopause study will receive raloxifene for six months. Half the women in the study also will engage in an aerobic exercise intervention – primarily walking – for the last three of the six-month program.

Participants interesting in enrolling in the study must meet the following requirements: age of between 45 and 69 years, no menstrual period for 12 months (due to hysterectomy or natural menopause), no personal history of breast cancer, elevated blood pressure and no use of estrogen or any heart medications for the past 12 months.

Qualified participants will receive a free gynecological examination (if needed), free echocardiogram, free study medication (Evista) for six months, free cholesterol and blood pressure profiles, free health and fitness education and $650 for study completion.

"Ultimately, we hope that the information gathered from this study will help postmenopausal women and their physicians to make meaningful, effective decisions regarding the management of their blood pressure and long-term cardiovascular health," Brownley said.

The National Heart, Lung and Blood Institute, a component of the National Institutes of Health, funded this research. Along with Brownley, UNC co-investigators are Drs. Kathleen Light, Alan Hinderlighter, Susan Girdler, Ellen Wells and William Maixner.

To volunteer for the study, contact Amanda at (919) 843-2483.

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Note: Contact Brownley at (919) 966-2544 or kim_brownley@med.unc.edu.
School of Medicine contact: Les Lang, (919) 843-9687 or llang@med.unc.edu