Researchers chronicle the threat of estrogen
and progestin three years after women in a
study stopped the treatment.
Three years after they stopped hormone
replacement therapy, women who took the
drugs still had a 27% higher risk of
developing breast cancer than those who took
a placebo, researchers reported today.
The women were participants in the Women's
Health Initiative, halted abruptly in 2002
when researchers found that the doses of
estrogen and progestin increased patients'
risk for heart disease, stroke and breast
Although the heart risks eased after the
women stopped taking the drugs, their
overall cancer risk remained 24% above
"Menopausal women really need to think
through whether using estrogen-progestin is
the right thing to do, particularly if
continued for more than a few years," said
Marcia L. Stefanick, a professor of medicine
at Stanford University and one of the
authors of a paper appearing in the Journal
of the American Medical Assn.
Physicians taking the medical history of a
new patient past menopausal age should "ask
specific questions about past use of hormone
therapy" and be alert for possible problems,
said Dr. Robert W. Rebar, executive director
of the American Society for Reproductive
Medicine, who was not involved in the study.
"The important message is women really need
to make sure they continue getting their
mammograms," Stefanick said.
Some experts noted that hormone use had
changed dramatically since 2002, with
physicians prescribing lower doses for
shorter periods of time. They are also
giving the drugs to younger women -- a group
that the Women's Health Initiative found was
less likely to suffer adverse effects.
"We really don't believe this latest article
provides any new guidance," said Dr. Gary
Stiles, chief medical officer of Wyeth
Pharmaceuticals, which manufactures the
Prempro used in the study. "We continue to
recommend it be used at the lowest effective
dose for the shortest duration of time
The Women's Health Initiative originally
enrolled 16,608 women with an average age of
63 who were given either Prempro -- a mix of
estrogen and progestin -- or a placebo. The
goal was to determine whether the hormones
could protect against heart disease.
But the study was stopped prematurely after
an average of 5.6 years when it was
determined that women taking the hormones
had a 26% higher risk of breast cancer as
well as an increased risk of stroke, blood
clots and heart attack.
Subsequent analysis, however, showed that
younger women beginning treatment at
menopause about 50 did not share the
Since 2002, sales of Prempro have dropped
from $2 billion a year to a little more than
$1 billion. Breast cancer rates also have
fallen, and many experts attribute the
decrease to lower rates of hormone
The new study, funded by the National Heart,
Lung and Blood Institute, followed 15,730 of
the original trial participants for an
average of three years after they stopped
The researchers found 281 cancers in the
group receiving Prempro, compared with 218
in the placebo group, a difference driven
primarily by breast cancers. The rate of
deaths from all causes was 15% higher in the
Prempro group, but the difference was not
considered statistically significant.
There were 343 heart attacks, strokes and
blood clots in the Prempro group and 323 in
the placebo group, a statistically
At a news conference sponsored by Wyeth, Dr.
Hugh S. Taylor of the Yale University School
of Medicine cautioned that, with the uproar
over possible harm from hormone replacement
therapy, physicians should not lose sight of
the hot flashes, vaginal atrophy, sexual
problems and insomnia associated with
"They can have a dramatic effect on women.
Careers and relationships suffer," he said.
"It's important that we don't trivialize
quality of life."
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