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ARTERIAL PLAQUE SIGNIFICANTLY REDUCED IN WOMEN AGE 50-59 TAKING HORMONES, SAYS NEW ANALYSIS OF WOMEN'S HEALTH INITIATIVE DATA

Fourth Study to Indicate that Early Use of Estrogen May be Cardio-Protective

(Phoenix) June 20, 2007 — A new analysis of Women's Health Initiative data published in the New England Journal of Medicine, shows significant reduction in calcified plaque for women aged 50 to 59 using hormone therapy (HT) compared with women taking a placebo. This is the first time the relationship between estrogen therapy and coronary artery calcium (CAC) has been evaluated in a randomized trial.

The amount of CAC is now well-recognized as a strong predictor of future heart attacks and other coronary events. Using cardiac CT scans, CAC was measured in 1064 WHI women. After adjustment for other coronary risk factors, the risks of having mild-to-moderate CAC were 20 to 30 percent lower and the risks of severe CAC were 40 percent lower in the group of women assigned to the active HT group compared to those receiving placebo. Even more impressive was the finding that mild-to-moderate CAC scores were 40 to 50 percent lower and severe CAC was 60 percent lower in those women who were actually taking their study medications regularly.

"This is the fourth peer-reviewed re-analysis of WHI data to suggest that estrogen may be cardio-protective for younger women," said Dr. S. Mitchell Harman, Director of the Kronos Longevity Research Institute (KLRI). The Institute is conducting the Kronos Early Estrogen Prevention Study (KEEPS), a randomized, controlled, double-blinded trial of 720 recently menopausal women at nine study centers across the United States. The KEEPS is designed to provide prospective data on the risks and benefits of early menopausal HT, particularly as it relates to the progression of atherosclerosis "The new findings from the WHI continue to support the KEEPS hypothesis that hormones may be good early, but bad late," Dr. Harman said.

This latest study follows an April article in the Journal of the American Medical Association which found a 24 percent reduction in risk for coronary heart disease in women starting hormone therapy less than ten years after menopause. The JAMA study also found a 30 percent reduction in over-all deaths among women aged 50-59 using HT.

An earlier re-analysis of WHI data, summarized in articles in the Journal of Women's Health and the Archives of Internal Medicine in early 2006, also indicated that estrogen may be cardio-protective for younger women. The Women's Health Initiative was halted in July 2002 due to over-all elevated risks.

"These findings lend further support to the theory that estrogen may slow early stages of plaque build-up and lead to less 'hardening' of the arteries supplying blood flow to the heart," said Dr. JoAnn Manson, from Brigham and Women's Hospital in Boston. Dr. Manson is the lead physician who contributed to the "Estrogen Therapy and Coronary Artery Calcification" study. She is also the lead investigator for the KEEPS trial at the study center in Boston.

Interviews are available by the investigators at all nine KEEPS study centers:

• Albert Einstein College of Medicine of Yeshiva University/Montefiore Medical Center, Bronx, NY
• Columbia University College of Physicians and Surgeons, New York, NY
• Harvard Medical School/Brigham and Women's Hospital, Boston, MA
• Kronos Longevity Research Institute, Phoenix, AZ
• Mayo Clinic College of Medicine, Rochester, MN
• University of California-San Francisco/Center for Reproductive Health, San Francisco, CA
• University of Utah School of Medicine, Salt Lake City, UT
• University of Washington School of Medicine, Seattle, WA
• Yale University College of Medicine, New Haven, CT