Premarin and Prempro
Information on Hormone Replacement Therapy - Causes Breast Cancer Risk.
Health risk to women halts hormone
study
BYLINE: PATRICIA GUTHRIE; Staff
DATE: July 9, 2002
PUBLICATION: Atlanta Journal-Constitution, The (GA)
EDITION: Home; The Atlanta Journal-Constitution
SECTION: News
PAGE: A1
Researchers abruptly halted a major federal study of hormone
replacement therapy -- used by tens of millions of American women --
because the drugs create what they consider an unacceptable risk for
breast cancer, heart disease, strokes and blood clots.
The study found women taking a combination of estrogen and progestin are
at increased risks that outweigh the benefits of the hormones, which
were found to reduce the risks of colon cancer and hip fractures.
Findings from the study, called the Women's Health Initiative, had not
been expected until 2008. But when evidence of the risks started
accumulating after five years, a review panel ordered the clinical trial
stopped -- something rarely done in medical studies.
(For WHI press release,
click here.)
"The bottom line is that estrogen plus progestin is not a viable option
to prevent chronic disease," said Dr. Gerardo Heiss, epidemiology
professor at the University of North Carolina at Chapel Hill School of
Public Health, who was on the study steering committee.
A hastily called news conference to discuss the findings is scheduled
for this morning in Washington and at numerous participating academic
centers, including Emory University.
The study is being released early on the Journal of the American Medical
Association Web site (www.jama.com) before appearing in print July 17.
In the JAMA article, researchers noted: "Given these results, we
recommend that clinicians stop prescribing this combination for
long-term use."
The study involved 16,608 postmenopausal women, 50-79 years old, who had
not had hysterectomies.
At Emory University, 286 metro Atlanta women were involved in the study,
a spokeswoman said.
Hormone replacement therapy is the second most frequently prescribed
drug regimen in America: 68 million prescriptions were written in 2000
for the two most popular forms, Premarin and Prempro. It has been
prescribed for almost 60 years.
The trial was stopped early "because of a 26 percent increased risk for
breast cancer and also a lack of overall benefit," Heiss said. "As soon
as the increased risk for breast cancer was established, the independent
data and safety monitoring board halted the study."
Experts advised women to consult their physician to discuss risks and
benefits before stopping hormone therapy.
The drug relieves menopausal symptoms, such as hot flashes, night sweats
and inability to concentrate. It is also prescribed in postmenopausal
women for protection against heart disease and osteoporosis, which
previous studies indicated it might provide.
Many studies in recent years have attempted to quantify the risks and
benefits of hormone replacement therapy, such as the increased incidence
of breast cancer or heart disease, or the reduced risk of osteoporosis
among women who take HRT. But past research has typically examined
various risks and benefits in isolation.
The latest study is believed to be the largest and most comprehensive to
examine and quantify all known risks and benefits and lay them out side
by side.
Although researchers advised doctors to stop prescribing HRT, they also
emphasized that the risk of harm to an individual woman is "very small."
Among 10,000 women taking the estrogen/progestin combination,
researchers estimated that there would be seven more cases of coronary
events, eight more breast cancers, eight more strokes and eight more
blood clots -- but six fewer colorectal cancers and five fewer hip
fractures -- than they would expect to find in women who don't take the
drugs.
Women in the study were divided into two groups -- those who took the
hormones and those who took a placebo. Scientists compared health
outcomes between the groups; the women were not told to which group they
were assigned.
Another part of the study involved 11,000 women who had undergone
hysterectomies and were taking only estrogen. That study has not been
stopped because no adverse effects have been found, researchers said.
The study did not address the short-term risks and benefits of hormones
given only for the treatment of menopausal symptoms.
Dr. Rogsbert Phillips, an Atlanta breast cancer specialist, said the
findings were not that surprising, given past research that raised
questions about the risks of HRT. The breast cancer/hormone replacement
connection weighs heavily on doctors when they are assessing whether to
place a woman on hormone replacement therapy, she said.
" It's no question that we feel that HRT plays a role in development of
breast cancer, and as we continue to research, we'll find out how much,"
Phillips said.
The doctor said she rarely prescribed HRT for more than five years.
However, she will make exceptions, she said, even for women who have
experienced breast cancer.
"I had one patient who was a mathematician and she said she just
couldn't think straight when she went off hormone replacement therapy.
She was a 20-year breast cancer survivor," Phillips said. "But I put her
back on them.
"There are some women who really, truly need it to manage these kinds of
menopausal symptoms. Hormones can greatly affect a woman's equilibrium."
