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A new study is set to reopen the public debate over menopausal hormone therapy (HT). By focusing on younger, recently menopausal women, the Kronos Early Estrogen Prevention Study (KEEPS) seeks to show that supplemental estrogen prevents or delays the onset of heart disease the number one killer of women. NewYork-Presbyterian Hospital and Columbia University Medical Center is one of eight national study sites.

The four-year randomized clinical trial will recruit 720 women in order to determine whether estrogen slows the rate of hardening of the arteries (atherosclerosis), the major cause of heart attacks. The study will also examine if an estrogen skin patch is more effective than an estrogen pill. HT reduces symptoms of menopause including hot flashes, abnormal vaginal bleeding, and mood changes.

"Hormone therapy isn't for everyone, but there is very good evidence that it could be beneficial to younger, recently menopausal women," says Dr. Rogerio A. Lobo, who leads the NewYork-Presbyterian/Columbia KEEPS study center. Dr. Lobo is professor of obstetrics and gynecology at Columbia University College of Physicians and Surgeons and attending obstetrician and gynecologist at NewYork-Presbyterian/Columbia. "Estrogen is thought to have a protective effect against atherosclerosis by decreasing the level of 'bad' LDL cholesterol and increasing 'good' HDL cholesterol, as well as having many other beneficial effects on arteries. On the other hand, it may accelerate the onset of heart attacks in older women who already have patches of advanced atherosclerosis in their arteries. Therefore, the effect of estrogen may be positive when used early and deleterious when used late."

In 2002, the Women's Health Initiative (WHI) hormone study was discontinued after six years because the risks of menopausal hormone therapy (breast cancer, clotting-related disease, and heart attacks) appeared to exceed the benefits. The average age of WHI study participants was 63 years. "It is very likely that many of these women already had pre-existing-but-silent atherosclerosis," explains Dr. Lobo.

The KEEPS study will be conducted at eight national sites, with approximately 720 peri-menopausal women ages 42 to 58 whose last menstrual cycle occurred within six to 36 months. All potential study participants will be carefully screened, including for presence of atherosclerosis. Screenings will include a coronary calcium scan, intimal-medial thickness (IMT) of the carotid artery, and a blood pressure test, among others.

Qualified study participants will then be divided into three groups to receive either estrogen in the form of a pill or skin patch, or a placebo. Women receiving active estrogen will also receive micronized progesterone, a form of the hormone progestin that is more easily absorbed than the medroxyprogesterone acetate used in the WHI study which some believe was responsible for the increased rate of breast cancer among that study's participants. Progesterone is necessary to protect from cancer-promoting build-up of the uterine lining caused by the estrogen.

The study is funded by the Phoenix-based Aurora Foundation (a private foundation with no pharmaceutical affiliations) and is coordinated through Phoenix-based Kronos Longevity Research Institute (KLRI). For further information on the KEEPS study, visit www.keepstudy.org.

NewYork-Presbyterian Hospital based in New York City is the largest not-for-profit, non-sectarian hospital in the country, with 2,344 beds. It provides state-of-the-art inpatient, ambulatory, and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, Morgan Stanley Children's Hospital of NewYork-Presbyterian, The Allen Pavilion, and The Westchester Division. One of the largest and most comprehensive health-care institutions in the world, the Hospital is committed to excellence in patient care, research, education, and community service. It consistently ranks as one of the top hospitals in the country in U.S.News & World Report's guide to "America's Best Hospitals," in New York magazine's Best Doctors issue, in Solucient's top 15 major teaching hospitals, and in many other leading surveys. The Hospital has academic affiliations with two of the country's leading medical colleges: Joan and Sanford I. Weill Medical College of Cornell University and Columbia University College of Physicians & Surgeons.

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