The
news, published in this week's Journal
of the American Medical Association, was the latest in a
sometimes confusing stream of reports on estrogen combined with
progestin to combat post-menopausal problems.
The
hormones have been shown to halt or reverse osteoporosis, lessen
the risk of hip fractures and prevent uterine cancer. But a major
government study on long-term use was halted last summer after
it showed the estrogen-progestin combination sold as Wyeth's
Prempro carried an increased risk of ovarian cancer, heart attack
and stroke.
Studies
are continuing to determine whether estrogen alone is safer when
not combined with progestin; drug makers also believe lower doses
of the drugs are safer.
Tuesday's
report from Wake Forest University Baptist Medical Center involved
an offshoot of the study which was halted.
It
found the hormone combination doubled the risk for probable dementia
in women 65 and older and did not prevent mild cognitive impairment.
Translated to a population of 10,000 women taking the combined
therapy, that would mean an additional 23 cases of dementia per
year, it said.
The
study involved 4,532 women, about half of whom received the drugs
while the rest were given an inert placebo.
Wyeth
issued a statement saying it had revised its labeling to reflect
the findings, but also said the average age of women in the study
was 71, a level where the risk of dementia is higher to begin
with than 51, the average age when therapy starts.
"The
overall individual risk to women is low, although there is reason
for concern," said principal investigator Sally Shumaker. "Because
of the potential harm and lack of benefit found, we recommend
that older post-menopausal women not take the combination hormone
therapy to prevent dementia."
The
Food and Drug Administration issued a statement saying it will
not require any changes in labeling for affected products but
in general women
should talk to their doctors before using estrogen-progestin
products. 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 effects," it said."
The
same researchers, in a separate report, also looked at overall
cognitive functioning in the women, including concentration,
language, memory and abstract reasoning.
They
found that women taking estrogen-progestin performed slightly
worse than the placebo group.
The
study was funded by Wyeth Pharmaceuticals and the National Institutes
of Health.
Wyeth
has won U.S. government approval to market lower-dose forms of
estrogen-only Premarin and Prempro. Since the government test
on the stronger strength drug was halted last year, combined
sales of Premarin and Prempro have plunged 40 percent.