May 29, 2003
WHIMS Study on Estrogen/Progestin
-The Food and Drug Administration (FDA) said today that the results of a
Women’s Health Initiative (WHI) study on the effects of combined estrogen
with progestin therapy on the incidence of dementia and memory impairment do
not at this time dictate any changes to the FDA-approved uses of these drug
therapies. FDA is reviewing the new information and will determine whether
labeling should be updated so that women and prescribers are fully informed
about use of these therapies.
In keeping with recommendations made earlier this year after the publication
of the original results of the WHI study showing unexpected risks of
combined estrogen and progestin, FDA emphasizes that combined estrogen and
progestin is effective for treating moderate to severe symptoms of hot
flashes and night sweats and the treatment of moderate to severe symptoms of
vulvar and vaginal (burning, itching, and dryness in and around the vagina).
However, the FDA and the current labels for these drugs advise that topical
vaginal products should be considered when use of estrogen plus progestin is
intended solely for the treatment of symptoms of vulvar and vaginal atrophy
(burning, itching, and dryness in and around the vagina). When intended for
the prevention of osteoporosis, approved non-estrogen treatments should be
FDA continues to advise women to talk to their doctors, and if they decide
that estrogen and progestin containing products are appropriate, they should
use the lowest dose for the shortest duration to reach treatment goals,
although it is not known at what dose there may be less risk of serious side
FDA advises consumers and physicians that estrogen, and estrogen with
progestin, have never been approved for prevention of cognitive disorders,
such as Alzheimer’s Disease or memory loss.
The results of the Women’s Health Initiative Memory study (Whims) were
published in today’s Journal of the American Medical Association (JAMA). FDA
will be reviewing the data from this substudy of the Women's Health
Initiative program (WHI), which is sponsored by the National Institutes of
Health. The authors of the dementia study concluded:
The combination estrogen and progestin (Prempro) increased the risk of
dementia in women 65 and older and failed to prevent mild cognitive
impairment (memory loss). The estrogen plus progestin combination studied in
WHIMS does not prevent dementia or slow progress toward dementia over time.
Older women should not take estrogen and progestin to prevent dementia or to
preserve cognition (memory).
The study published today included 4,500 (of the 16,000 WHI participants)
women between 65 and 79 years of age; half were taking Prempro and half were
Sixty women were diagnosed with dementia. Of these, 39 (65%) were in the
estrogen with progestin group and 21 (35%) were in the placebo group.
Although these findings are statistically significant, the risks to
individual women are small. Participants in the study were at least 15 years
older than the typical newly menopausal woman.
The WHIMS study was undertaken as a result of numerous epidemiological
studies, conducted over the last decade or more that suggested that hormone
therapy may reduce the risk of Alzheimer’s disease in women. It should be
noted that evidence from small clinical trials had not shown effectiveness
of hormone therapy in this regard. Until the full review process has been
completed, FDA will not have a final conclusion on the impact of these
findings on use of postmenopausal estrogen and estrogen plus progestin
products. FDA will work with the manufacturers on new label information
should the agency decide that it is needed. FDA will also continue to engage
the National Institutes of Health (which sponsored the WHI) as well as
manufacturers to pursue research on questions addressing the safe and
effective use of estrogens and progestin therapies.
The other major arm of the WHI, involving women without a uterus treated
with estrogen alone or placebo, is still ongoing.