EMBARGOED FOR RELEASE.
U.S. Department of Health and Human Services
National Institutes of Health Press Release:
Tuesday, June 22, 2004
4:00 p.m. ET.
Estrogen-Alone Hormone Therapy Could Increase Risk
of Dementia in Older Women.
Older women using estrogen-alone hormone therapy could be at a
slightly greater risk of developing dementia, including Alzheimer's
disease (AD), than women who do not use any menopausal hormone
therapy, according to a new report by scientists with the Women's
Health Initiative Memory Study (WHIMS). The scientists also found that
estrogen alone did not prevent cognitive decline in these older women.
These findings from WHIMS appear in the June 23/30, 2004, Journal of
the American Medical Association*.
"These studies further support last year's recommendations that
menopausal hormone therapy should not be used to prevent cognitive
decline or dementia in older postmenopausal women," stated Judith A.
Salerno, MD, MS, Deputy Director of the National Institute on Aging
(NIA). "Women should follow the Food and Drug Administration's
recommendation that those who want to use menopausal hormone therapy
to control their menopausal symptoms should use it at the lowest
effective dose for the shortest time necessary."
The latest findings were reported by WHIMS Principal Investigator
Sally A. Shumaker, PhD, Wake Forest University School of Medicine, and
her colleagues at the 39 study sites. This research was funded by
Wyeth Pharmaceuticals, which manufactures Premarin™, the conjugated
equine estrogens used in this trial, and Wake Forest University
Baptist Medical Center. WHIMS is a substudy of the Women's Health
Initiative (WHI) Hormone Trial, which is funded by the National
Institutes of Health (NIH) at the Department of Health and Human
Services (DHHS). The National Institute on Aging (NIA), a component of
NIH, has been involved in reviewing the current findings as the lead
NIH institute on age-related cognitive change and dementia.
The WHI Hormone Trial using estrogen plus progestin was stopped early
in July 2002 when researchers found an increased risk of breast
cancer, along with greater risks of heart disease, stroke, and blood
clots, and determined that these risks outweighed the benefits of
reduced risks of hip fracture and colorectal cancer. In May 2003,
WHIMS investigators reported the results of the estrogen plus
progestin part of their memory substudy**. They found that estrogen
plus progestin increased the risk of probable dementia in women 65 and
older and did not preserve cognitive function. This part of WHIMS was
also stopped in July 2002.
At the end of February 2004, the remaining parts of the WHI Hormone
Trial and WHIMS, the estrogen-alone components, were halted because
results were showing an increased risk of stroke and no reduction in
the risk of heart disease in the women using estrogen alone.
Scientists further believed that continuing the study until its
planned conclusion next year would probably not add new information.
In April 2004, the WHI investigators reported that they found an
increased risk of blood clots, but no significant effect on breast or
colorectal cancer and also a reduced risk of fractures in those women
using estrogen alone.
Now, the WHIMS scientists have evaluated the cognition and dementia
data from the estrogen-alone part of the trial. Some 2,947 women age
65 to 79 at the beginning of the trial received estrogen alone (a
daily dose of 0.625 mg of Premarin™) or a placebo. (The women received
estrogen alone because they had all had hysterectomies at some time
before beginning the study. A progestin is used with estrogen in
menopausal hormone therapy in any woman with a uterus to prevent
thickening and, sometimes, cancer of the lining of the uterus, the
endometrium. Because the uterus is removed in a hysterectomy, there is
no need for progestin when women who have had hysterectomies use
menopausal hormone therapy.)
Participants were determined to be dementia free before they were
enrolled in WHIMS. At the beginning and then annually for the more
than 5-year average duration of the trial, WHIMS participants were
evaluated to determine if they might have developed dementia or mild
cognitive impairment (MCI). All women received the Modified Mini
Mental State Exam (3MSE), and those suspected of having dementia also
received an extensive clinical evaluation by a specialist physician.
At the end of the study, the risk of dementia in the estrogen-alone
group was 49% higher than the risk in women using the placebo. That
is, among 10,000 women using conjugated equine estrogens, 37 could be
expected to develop dementia, compared to 25 in 10,000 women using the
placebo — 12 extra cases of dementia in every 10,000 women using
estrogen alone each year. This increased risk was not statistically
significant.
Last year WHIMS scientists reported a 105% increase in the risk of
dementia in older women using estrogen plus progestin compared to
those using a placebo. That means, on average, each year in 10,000
women over age 65 using estrogen plus progestin there might be 45
cases of dementia compared to 22 cases in 10,000 older women on
placebo.
Almost half of the dementia cases in the estrogen-alone study — 46% in
older women using estrogen alone and 47% of those in older women using
the placebo — were Alzheimer's disease (AD). Similarly, in the
estrogen plus progestin study, 50% of the cases in older women using
estrogen plus progestin and 57% of those in older women using placebo
were classified as AD.
A second article on general cognitive function *** from Mark A.
Espeland, PhD, and other WHIMS investigators appears in the same issue
of JAMA. It reports that beginning estrogen-alone hormone therapy
after age 65 can have a small negative effect on overall cognitive
abilities and that this negative effect may be greater in women with
existing cognitive problems. The differences in scores on cognitive
testing for the estrogen-alone and placebo groups were statistically
significant, but the differences were so small that they are not
considered clinically relevant by the investigators.
As with the earlier WHI and WHIMS result reports, these increases in
risk must be viewed in perspective. Significant increases in risk are
important for public health officials who are concerned with large
groups in the population, where a small increase could have health
implications for millions of people. For an individual woman, however,
the increased risk is still quite small. (A detailed discussion of
risk is presented in the NIA Fact Sheet, Understanding Risk: What Do
Those Headlines Really Mean?, available online at http://www.niapublications.org/engagepages/risk.asp.)
Further, these findings relate to women age 65 and older taking this
particular estrogen-alone hormone therapy. The cognitive risks and
benefits for younger women using Premarin™ or other estrogen
formulations are unknown. Any younger woman who is considering
menopausal hormone therapy because of her menopausal symptoms should
talk to her doctor about how the various Women's Health Initiative
study findings relate to her own medical history and treatment.
General information on menopause, menopausal hormone therapy, and the
Women's Health Initiative can be found on the NIH home page,
www.nih.gov, by clicking on the link "Menopausal Hormone Therapy," or
by going directly to www.nih.gov/PHTindex.htm.
The NIA leads the Federal research effort on aging in general and on
aging and memory, including Alzheimer's disease. For more information
on these topics, the public and media are invited to visit the NIA's
websites. Information on memory and Alzheimer's disease may be viewed
at www.alzheimers.org, the NIA's Alzheimer's Disease Education and
Referral (ADEAR) Center website. The general public also may call the
ADEAR Center toll free at 1-800-438-4380. General information on
health and aging may be viewed at www.nia.nih.gov. Publications may be
ordered online at www.niapublications.org or by calling the NIA
Information Center toll free at 1-800-222-2225.
*
Shumaker SA, Legault C, Kuller L, Rapp SR, Thal L, Lane DS, Fillit H,
Stefanick ML, Hendrix S, Lewis CE, Masaki K, Coker LH, Conjugated
Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive
Impairment in Postmenopausal Women: Women's Health Initiative Memory
Study. JAMA. 2004; 291: 2947-2958.
**
Shumaker SA, Legault C, Rapp SR. Estrogen plus progestin and the
incidence of dementia and mild cognitive impairment in postmenopausal
women. The Women's Health Initiative Memory Study: a randomized
controlled trial. JAMA. 2003; 289:2651-2662.
Rapp S, Espeland MA, Shumaker SA, et al. Effect of estrogen plus
progestin on global cognitive function in postmenopausal women:
Women's Health Initiative Memory Study; A Randomized Controlled Trial.
JAMA. 2003; 289: 2663-2672.
***
Espeland MA, Rapp SR, Shumaker SA, Brunner R, Manson JE, Sherwin BB,
Hsia J, Margolis KL, Hogen PE, Wallace R, Dailey M, Freeman R, Hays J
for the Women's Health Initiative Memory Study. Conjugated Equine
Estrogens and Global Cognitive Function in Postmenopausal Women:
Women's Health Initiative Memory Study. JAMA. 2004; 291: 2959-2968.
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