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PRESS RELEASE

July 3, 2007

FIVE YEARS AFTER THE WOMEN'S HEALTH INITIATIVE - WHAT WOMEN SHOULD KNOW

July 03, 2007 (Phoenix) — This month marks five years since the Women's Health Initiative halted its landmark study on women taking estrogen replacement therapy. At that time government scientists told women hormone replacement therapy or HRT would not protect them from heart attack and stroke and might even increase their risks. Since then, researchers have largely reversed their position, concluding women who take hormones at the start of menopause may actually gain health benefits.
A great amount of research has come out in the last five years, including several reanalyses of the WHI data. This is what we know today:

1. Current research continues to show estrogen may protect women from heart disease when given close to the menopausal transition. Studies show estrogen may actually slow early stages of plaque build-up and lead to less 'hardening' of the arteries supplying blood flow to the heart¹.
   
   
2. Transdermal Patch- evidence shows that disease due to blood clots in the veins (thrombphlebitis and pulmonary embolus), seen with oral estrogens, do not occur if women treated with the patch. The patch has beneficial effects on blood cholesterol similar to those of estrogen pills, but less is know about whether the patch actually helps slow hardening of the arteries.
   
   
3. Risk Benefit ratio- An increase in risk of breast cancer in women taking estrogen of about 30% after five years of use remains a concern. However, because heart disease kills nearly 10 times more women than does breast cancer, a period of estrogen use beginning at menopause may provide benefits in the long term that outweigh this risk in all but those women at highest risk for breast cancer.
   
   
4. When to stop? How long estrogen use should continue, once initiated, is uncertain, but between five to ten years of use appears to provide significant reductions in risk of heart attack and bone fractures. More research is needed on this important issue. Current FDA guidelines call for use of estrogen only for relief of menopausal symptoms and then with the smallest effective dose for the shortest time possible.

The Kronos Longevity Research Institute, based in Phoenix, Arizona is conducting the Kronos Early Estrogen Prevention Study (KEEPS) at nine study centers across the United States. KEEPS is a randomized, controlled, double-blinded trial of 720 women designed to provide prospective data on the risks and benefits of early menopausal HT, particularly as it relates to the progression of atherosclerosis.

The KEEPS will also examine whether the natural human estrogen, estradiol, delivered through the skin via a patch is equally effective as, and potentially safer than, oral estrogen. Researchers have speculated that this method may be safer since transdermal estrogen does not go to the liver in high concentrations and has been shown to have little or no effect on clotting disease.

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

¹ The following research illustrates how estrogen can be cardio-protective for women close to menopausal transition:
Judith Hsia, MD et al., "Conjugated Equine Estrogens and Coronary Heart Disease," Archives of Internal Medicine, vol. 166 (2006) 357.
Kathryn Rexrode, MD; JoAnn Manson, MD, "Are Some Types of Hormones Safer Than Others? Lessons from the Estrogen and Thromboembolism Study Risk Study," Circulation, February 20, 2007.
Jacques E. Rossouw, MD et al., "Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years since Menopause," Journal of the American Medical Association 297, no. 13 (2007), 1465.
JoAnn E. Manson, MD et al., "Estrogen Therapy and Coronary-Artery Calcification," New England Journal of Medicine 356, no. 25 (2007), 2591.