Wyeth Pharmaceuticals - Younger menopausal women (aged 50 to 59) who received a standard dose of oral conjugated estrogens had significantly less coronary artery calcification at the end of the study period compared with those taking placebo. Coronary artery calcification is a marker of plaque in the arteries and a predictor of future cardiovascular events. The study is the Women’s Health Initiative (WHI) Coronary Artery Calcium Study published June 2007 in The New England Journal of Medicine (NEJM) [See editorial note at the end of this news post].

“In the five years since the WHI study ended, new data have emerged that help put the initial findings into perspective. These results showed that in these younger menopausal women, estrogen therapy reduced calcified plaque buildup in the arteries,” says Howard Hodis, M.D., Professor of Medicine and Preventive Medicine; Director, Atherosclerosis Research Unit, University of Southern California. “These data support initiation of estrogen therapy, where indicated when a woman first enters menopause and begins experiencing symptoms and bone loss.”

These findings are consistent with a recent re-analysis of pooled estrogen alone and estrogen plus progestin data from the WHI study, published April 4, 2007 in the Journal of the American Medical Association (JAMA). This study found no apparent increase in coronary heart disease for women who initiated hormone therapy within 10 years of menopause; and a statistically significant reduction in total mortality among women aged 50 to 59 in the group receiving hormone therapy compared with those in the placebo group.

“The recent pooled analysis published in JAMA provides reassurance about coronary artery disease to newly menopausal women considering estrogen plus progestin therapy or estrogen alone therapy for symptom relief and prevention of postmenopausal bone loss. The data published today in NEJM provide additional evidence for women considering estrogen alone therapy,” says Joseph Camardo, M.D., Senior Vice President of Global Medical Affairs for Wyeth Pharmaceuticals. “We hope this information can help clarify the clinical perspective for women who choose hormone treatment for menopausal symptoms and prevention of osteoporosis.”

The authors conclude, “Hormone therapy should not be initiated (or continued) for the express purpose of preventing cardiovascular disease in either younger or older postmenopausal women.” The authors further state, “The current recommendations from many organizations that hormone therapy be limited to the treatment of moderate to severe menopausal symptoms, with the lowest effective dose used for the shortest duration necessary, remain appropriate.” Hormone therapy is not appropriate for all women. Women experiencing menopausal symptoms are encouraged to speak with their health care professional to determine whether hormone therapy might be the right treatment option for them.

The WHI was a large-scale study sponsored by the National Institutes of Health that was designed to evaluate hormone therapy, dietary modification, calcium and vitamin D as preventive therapies for menopausal women. The hormone therapy arms were designed to assess select long-term risks and benefits of hormone therapy. The WHI studied conjugated estrogens (0.625 mg) (PREMARIN® [conjugated estrogens tablets, USP]) and oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) (PREMPRO™ [conjugated estrogens/medroxyprogesterone acetate tablets]).

What is the most important information you should know about PREMARIN (estrogens) or PREMPRO (a combination of estrogens and a progestin)?

• Estrogens increase the chances of getting cancer of the uterus.
• Report any unusual vaginal bleeding right away while you are taking these products. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your health care provider should check any unusual vaginal bleeding to find out the cause.
• Do not use estrogens with or without progestins to prevent heart disease, heart attacks, strokes or dementia.
• Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer and blood clots. Using estrogens, with or without progestins, may increase your risk of dementia, based on a study of women aged 65 years or older.

Editorial note: I post this study not with the aim of promoting oral prescription estrogen therapy, but in order to point out the noted window of protective effect from 50 to 59 years of age. Women interested in bioidentical hormone therapy may want to know this data. Also, this finding may be of use to those studying the effect of natural dietary plant estrogens, or phytoestrogens, on women’s cardiovascular health. Some of these dietary estrogens include soy phytoestrogens and enterolactone compounds that some people’s intestines produce from flax seed lignans. Perhaps these estrogenic compounds might have a cardioprotective effect in young post-menopausal women - Dr. Z.