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NIH
Asks Participants in Women’s Health Initiative Estrogen-Alone
Study to Stop Study Pills, Begin Follow-up Phase
NIH Asks Participants in
Women’s Health Initiative Estrogen-Alone Study to Stop
Study Pills, Begin Follow-up Phase
Statement from Barbara Alving, M.D., Director of
the Women’s Health Initiative
and Acting Director of the National Heart, Lung, and
Blood Institute
The National Institutes of Health (NIH) has
instructed participants in the estrogen-alone study of
the Women’s Health Initiative (WHI), a large
multi-center trial, to stop taking their study pills
and to begin the follow-up phase of the study.
Letters have been sent to all participants in the
estrogen-alone study, 11,000 healthy postmenopausal
women who have had a hysterectomy, informing them of a
recent NIH review of the study data. After careful
consideration of the data, NIH has concluded that with
an average of nearly 7 years of follow-up completed,
estrogen alone does not appear to affect (either
increase or decrease) heart disease, a key question of
the study. At the same time, estrogen alone appears to
increase the risk of stroke and decrease the risk of
hip fracture. It has not increased the risk of breast
cancer during the time period of the study.
The increased risk of stroke in the estrogen-alone
study is similar to what was found in the WHI study of
estrogen plus progestin when that trial was stopped in
July 2002. In that study, women taking estrogen plus
progestin had 8 more strokes per year for every 10,000
women than those taking the placebo. The NIH believes
that an increased risk of stroke is not acceptable in
healthy women in a research study. This is especially
true if estrogen alone does not affect (either
increase or decrease) heart disease, as appears to be
the case in the current study.
The NIH has determined that the results would not
likely change if the estrogen trial continued to its
planned completion in 2005. Furthermore, enough data
have been obtained to assess the overall risks and
benefits of the use of estrogen in this trial. WHI
researchers have begun a detailed analysis of the data
from the estrogen-alone study and expect to report
full results in the next two months. The report, to be
published in a peer-reviewed journal, will include
additional data collected through the end of February
2004.
A separate report will contain information on
probable dementia and/or mild cognitive impairment in
the women age 65 and older who participated in the
estrogen-alone WHI-Memory Study (WHIMS), an ancillary
study of the WHI Hormone Trials. Preliminary data
suggest that for the WHIMS participants who were on
estrogen alone when compared to the women who were
taking the placebo, there was a trend toward increased
risk of probable dementia and/or mild cognitive
impairment.
The WHI estrogen study was designed to assess the
effect of long-term use of hormone therapy in healthy
postmenopausal women on the prevention of heart
disease and hip fractures, and any associated change
in risk for breast cancer. It was not designed to
evaluate the short-term risks and benefits of hormones
for the treatment of moderate to severe menopausal
symptoms.
The estrogen-alone study involved women ages 50 to
79 years. Study participants were randomly assigned to
a daily dose of estrogen-- 0.625 mg/day of conjugated
equine estrogen (Premarin™)--or a placebo.
The NIH decision to stop the estrogen-alone trial
was made on February 2, 2004. In November and December
2003, the WHI Data and Safety Monitoring Board (DSMB),
an independent advisory committee which regularly
reviews study data and oversees the safety of study
participants, reviewed the latest data from the
estrogen-alone study. The DSMB was split as to whether
the study pills should be stopped or whether the pills
should be continued, provided that a letter would be
sent to the participants clearly informing them of the
stroke risks and other findings. After careful review,
the NIH decided that women in the estrogen-alone study
should stop taking their study pills.
The NIH advises women to continue to follow the FDA
guidance regarding hormone therapy. Currently the FDA
advises postmenopausal women who use or are
considering using estrogen or estrogen with progestin
to discuss the benefits and risks with their
physicians. These products are approved therapies for
relief from moderate to severe hot flashes and
symptoms of vulvar and vaginal atrophy. Although
hormone therapy is effective for the prevention of
postmenopausal osteoporosis, therapy should only be
considered for women at significant risk of
osteoporosis who cannot take non-estrogen medications.
The FDA recommends that estrogens and progestins
should be used at the lowest doses for the shortest
duration needed to achieve treatment goals.
The WHI involves over 161,000 women who are either
participating in a set of clinical trials to test
preventive measures for heart disease, fractures,
breast and colorectal cancer, or in a large
observational study. In addition to the trials of
estrogen alone and estrogen plus progestin, other WHI
trials are studying a low-fat eating pattern and
calcium/Vitamin D supplementation. These trials are
continuing.
Participants in all of the WHI studies will be
informed about the detailed results of the
estrogen-alone study at the time of their publication
in the next two months.
The estrogen-plus-progestin trial was stopped after
5.6 years of follow-up because of an increased risk of
breast cancer and because the risk of breast cancer,
coronary heart disease, stroke, and blood clots
outweighed the benefits on hip fracture and colorectal
cancer. Participants in the combined hormone therapy
study were assigned to either estrogen plus progestin
(0.625 mg of conjugated equine estrogens plus 2.5 mg
of medroxyprogesterone acetate) or to a placebo. Since
these women had a uterus, they were given progestin in
combination with estrogen, a practice known to prevent
endometrial cancer. Women who were enrolled in the
active phase of the estrogen-plus-progestin study are
currently in a follow-up phase and, like participants
in the estrogen-alone study, will be monitored to
assess long-term effects of hormone use.
WHI is sponsored by the National Heart, Lung, and
Blood Institute (NHLBI) in collaboration with the
National Cancer Institute, the National Institute of
Arthritis and Musculoskeletal and Skin Diseases, the
National Institute on Aging, and the Office of
Research on Women’s Health. Note: Wyeth Ayerst
Research provided the active hormone for the
estrogen-alone study and funded the WHIMS study.
NHLBI is part of the National Institutes of
Health (NIH), the Federal Government’s primary agency
for biomedical and behavioral research. NIH is a
component of the U.S. Department of Health and Human
Services. Additional information on menopausal hormone
therapy, including the WHI estrogen-plus-progestin
study, can be found on the
NIH Website:
www.nih.gov, on the
NHLBI Website: www.nhlbi.nih.gov, and on the
FDA Website:
www.fda.gov.
Additional information:
- Women’s
Health Initiative (www.nhlbi.nih.gov/whi)
-
Questions and Answers About the Estrogen-Alone Study
(www.nhlbi.nih.gov/whi/e-a_faq.htm)
- Women's
Health Initiative Memory Study (WHIMS) (www.wfubmc.edu/whims/)
-
FDA Statement on Postmenopausal Hormone Therapy
(www.fda.gov/cder/drug/infopage/estrogens_progestins/default.htm)
-
Postmenopausal Hormone Therapy (NHLBI) (www.nhlbi.nih.gov/health/women/index.htm)
-
Menopausal Hormone Therapy Information (NIH) (www.nih.gov/PHTindex.htm)
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