Hormone
study halted; patients told to stop treatment
Complete data from trial to be published in
mid-April
By SUSAN IPAKTCHIAN
A portion of the national Women’s Health
Initiative study dealing with estrogen therapy was halted Monday by
the National Institutes of Health a year before its scheduled
conclusion because of concerns that the estrogen increased the risk
of stroke while offering no protection against heart disease.
The stoppage affects about 11,000 postmenopausal women nationally
including 230 who participated in Stanford’s portion of the
trial, said Marcia Stefanick, PhD, professor (research) of medicine
at the Stanford Prevention Research Center and chair of the
national steering committee for the WHI study.
Local participants received letters Monday advising them to stop
taking the hormone study pills and encouraging them to contact
Stefanick’s office if they have questions.
Stefanick cautioned that researchers are still finalizing the data
from the estrogen portion of the study, which they plan to publish
in mid-April. Until then, they are informing women that the
increased risk of stroke associated with the estrogen used in the
study, known as conjugated equine estrogens, appears similar to
what was found in a related WHI study of the combination of
estrogen and progestin. In that study, there was an increase of
eight strokes per year for every 10,000 women compared with those
taking a placebo.
The initial data indicate that the estrogen doesn’t appear to
have any effect on the risk of developing heart disease, whereas it
does appear to reduce the hip fracture risk. It doesn’t
appear to increase the risk of breast cancer.
“The overall picture of the benefits versus the risks of
using the estrogen is reasonably well-balanced, but in the absence
of any indication that it protects against heart disease the NIH
felt that the increased risk of stroke among otherwise healthy
women was unacceptable,” Stefanick said.
WHI was launched in 1991 to examine the most common causes of
death, disability and impaired quality of life in postmenopausal
women. The 15-year, multimillion-dollar effort involves more than
161,000 women nationwide.
In addition to the studies of estrogen and the estrogen-progestin
combination, the study has arms examining the role of a low-fat
diet in reducing breast and colon cancer; the role of calcium and
vitamin D in fracture prevention; and an observational study to
identify disease predictors. Those arms are continuing.
In 2002, the arm dealing with the estrogen-progestin combination
was halted because of evidence that the participants experienced a
greater risk of breast cancer, heart attack, stroke and blood
clots.
Since then, women have received conflicting messages as to the need
for hormone replacement therapy. Stefanick encouraged women to
discuss their concerns with their physicians and to follow
guidelines from the U.S. Food and Drug Administration.
Those guidelines say that women should consider using hormone
therapy for relief of hot flashes and other symptoms related to
menopause. However, women are encouraged to use the lowest hormone
dose needed to achieve treatment goals and to limit the duration of
the therapy.
The FDA advises against the use of hormone therapy as a method of
preventing heart disease.
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