WHI Estrogen-Alone Findings - Letter for Healthcare Providers

April 2004
Dear Health Care Provider
 
You may have heard the news in early March that we asked participants in the Women’s Health Initiative (WHI) Estrogen-Alone trial to stop taking study pills and start a follow-up phase. The primary results of the trial are being published in the April 14the issue of the Journal of the American Medical Association (JAMA). Please see the JAMA web page for access to the full article (http://jama.ama-assn.org/).
 
The type of estrogen studied in the Estrogen-Alone trial was conjugated equine estrogens (CEE; Premarin®), at a dose of 0.625 mg/day. After 6.8 years of follow-up, CEE did not affect the risk of heart disease; however, it increased stroke risk by 12 excess cases per 10,000 women per year and tended to increase deep vein thrombosis by 6 per 10,000. There was no significant increase in pulmonary embolism. CEE did decrease hip fractures at a rate of 6 fewer per 10,000 women per year and reduced total bone fractures by 30%, which is similar to what we found in the WHI trial of estrogen combined with progestin. In contrast to combined hormones, CEE did not affect colorectal cancer rates and, unexpectedly, there was a suggestion that CEE decreased the rates of breast cancer. In summary, taking into account all of the diseases studied during 6.8 years of follow-up in the E-Alone study, we conclude that CEE should not be used to prevent chronic disease overall, and heart disease in particular.
 
In addition, early results from the WHI Memory Study (WHIMS) suggest that there may be some increased risk of probable dementia and/or mild cognitive impairment in women taking CEE compared to placebo. A separate report from WHIMS is expected within the next few months concerning these findings.
 
The following information is from a FDA press release on March 4, 2004:
 
The FDA emphasizes that when estrogen-containing products are used for relief of postmenopausal symptoms such as hot flushes, they should be used only when the symptoms are moderate to severe. When used for treating moderate to severe symptoms of vulvar and vaginal atrophy, FDA urges healthcare providers to consider the use of topical products first. In addition, when estrogen-containing products are prescribed only to treat postmenopausal osteoporosis, FDA recommends that they be considered only for women at significant risk for osteoporosis and for whom non-estrogen treatments are inappropriate.
 
The FDA also recommends that healthcare providers use the lowest dose and the shortest treatment duration needed to achieve treatment goals.
To further understand the long-term risks and benefits of hormone therapy, we are asking that all of the
 
WHI Hormone Trial participants--those in the Estrogen-Alone and the Estrogen-Plus Progestin trials--continue to have yearly mammograms and their regular WHI clinic contacts. Women should also continue to participate in other parts of the WHI, such as the Dietary, Calcium-Vitamin D, and Observational Study programs.
 
We hope that we can count on your support and collaboration in our efforts to answer the many questions that remain regarding hormone treatment in the menopause. Please contact me if you have any questions.
 
Respectfully,
PI