Study 'For Keeps': U Researchers Part of 8-Center Trial of Early Estrogen and Heart Disease

Study 'For Keeps': U Researchers Part of 8-Center Trial of Early Estrogen and Heart Disease

Feb 14, 2006 5:00 PM

SALT LAKE CITY - University of Utah researchers are seeking women for a nationwide study to verify recent reports that estrogen therapy begun in early menopause protects against cardiovascular disease.

Eliot A. Brinton, M.D., associate professor in cardiovascular genetics at the University of Utah, is the principal investigator in Utah for a new study, KEEPS (Kronos Early Estrogen Prevention Study). KEEPS is designed to help resolve a key controversy in the field of estrogen replacement: is estrogen good or bad for the heart?

In 2002, the National Institutes of Health stopped a large study of estrogen plus progestin-called the Women's Health Initiative (WHI)-because heart disease and cancer appeared to be increased. Another part of the WHI study, using estrogen alone, showed no increase in disease, but also no overall benefit. The official interpretation was that estrogen was generally harmful regardless of when it was started.

Furthermore, the recommendation was that women should avoid ever starting estrogen replacement, if possible, and should stop taking estrogen as soon as possible after starting it. Unfortunately, both parts of the WHI mainly studied women who started estrogen for the first time in their 60s or older.

The WHI studied something very different from the usual clinical practice of starting estrogen early in the menopause, and there is increasing evidence that their blanket conclusion, that estrogen is usually harmful and less is better, was wrong, Brinton said.

For example, a re-analysis of the WHI data, published this week in the Archives of Internal Medicine found that women who started estrogen at age 50-59 actually had a 34 percent to 45 percent reduction in heart disease. This new study provides further important evidence that the timing of when estrogen is started may determine whether estrogen is good or bad for the heart, Brinton said.

KEEPS is designed to verify this impression, that estrogen started early in the menopause may be beneficial to the arteries and the heart. Because heart disease is relatively rare in perimenopausal women, KEEPS will look primarily at effects of estrogen on atherosclerosis, or hardening of the arteries, by doing ultrasound scans of the main artery to the neck (the carotid).

KEEPS will also look at other aspects of atherosclerosis and risk factors for this disease (cholesterol, inflammation, etc.) and at other potential benefits of estrogen, including memory, sleep, blood sugar, bone density and joint preservation, and sexual function, Brinton said. Participants will be seen at the U of U about every three months throughout the four-years of the trial.

Brinton and his U of U colleagues are seeking 90 women ages 42-58 to take part in the four-year study. Women must be within three years of starting menopause, must not have had a hysterectomy, cannot smoke more than half a pack of cigarettes a day, and must not have diabetes or heart disease.

Study participants will be randomly assigned to one of three groups. One group will receive a low dose of Premarin; one will receive a low-dose estrogen skin patch; and the third group will receive placebo. This trial will be double-blind, meaning that neither participants nor researchers will know which group each woman is in. This is done by giving all participants both a patch and pill, one or both of which could be a placebo, to disguise what they are receiving. All medications are given a code so researchers don't know which a woman receives.

The University of Utah School of Medicine researchers are joining with seven other prominent U.S. medical centers to do this study, including Harvard, Columbia, Albert Einstein College of Medicine, Yale, Mayo Clinic (Rochester, Minn.), University of Washington, and the University of California, San Francisco.

KEEPS is sponsored by the Aurora Foundation and the Kronos Longevity Research Institute in Phoenix, AZ, and is not being paid for by the makers of any estrogen products.

Interested participants can call 801-585-0374 (or toll-free at 866-807-4517 outside the Salt Lake calling area) to see if they are eligible for the study.

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Contact:

Eliot A. Brinton, M.D., 801-581-3888, ext. 274 (office), 801-403-7530 (cell)

Phil Sahm, U of U Health Sciences Public Affairs, 801-581-7387

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