Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), reports that data
published today in the Journal of the American Medical Association (JAMA)
showed that in the estrogen-alone sub-study of the Women's Health
Initiative (WHI), conjugated estrogens 0.625 mg did not increase breast
cancer incidence in postmenopausal women. The authors also noted the
possibility of a protective effect of conjugated estrogens against breast
cancer incidence in three groups -- women with a low five-year estimated
risk of developing breast cancer as measured by the Gail Risk Score*, women
with no first-degree relatives with breast cancer, and women with no prior
history of benign breast disease. These latest results, in addition to
recent WHI study findings on cardiovascular disease, should be reassuring
for millions of women who are appropriate candidates for estrogen-alone
therapy.
"We know there are many symptomatic menopausal women who are
appropriate candidates for estrogen therapy but are afraid to take it due
to concerns about breast cancer risk," says Ginger Constantine, MD, Vice
President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals.
"It's important that women talk to their doctor or health care professional
about these new results because they show that conjugated estrogens did not
increase the incidence of breast cancer among the menopausal women
studied."
Today's report focuses on more detailed analyses of the WHI breast
cancer data. Overall, the study authors conclude that postmenopausal women
who have had a hysterectomy and were treated with conjugated estrogens
alone for an average of 7.1 years did not have an increased incidence of
breast cancer. Further analyses found that women who consistently took
conjugated estrogens as prescribed had a statistically significant decrease
in breast cancer risk (HR 0.67; 95% CI, 0.47-0.97; P = .03) compared to
women taking placebo.
Findings about breast cancer risk and hormone use have been mixed. Some
studies have reported an increased risk of breast cancer with hormone
therapy (HT). Other studies have not shown this increase, such as this WHI
estrogen- alone sub-study. The WHI estrogen-alone sub-study was a
prospective, randomized, placebo-controlled trial that enrolled more than
10,700 postmenopausal women age 50 to 79 years with a prior hysterectomy.
Preliminary findings from the WHI estrogen-alone sub-study were first
published April 14, 2004, in JAMA.
All women in the WHI estrogen-alone study underwent routine mammography
at the start of the study and then annually. This current study reported
that by the end of the first year, the percentage of mammograms requiring
short-term follow-up was significantly higher in the conjugated estrogens
group compared to the placebo group.
"The findings from this current study may be reassuring because even
with the reported increased number of abnormal mammograms and biopsies,
there was no reported increase in breast cancer incidence, and there was a
significant decrease in the most common type of breast cancer," says Hugh
Taylor, MD, Director of The Yale Menopause Program, Associate Professor,
Yale University School of Medicine, Department of Obstetrics, Gynecology
and Reproductive Sciences.
Two other articles were published this week in the Archives of Internal
Medicine. The first article summarized venous thrombosis (VT) data from the
WHI estrogen-alone study (Archives of Internal Medicine. 2006;166:772-780).
This report of increased risk of VT is consistent with data from other
studies and with information in the current product labeling. The other
article summarized findings from the Black Women's Health Study, a
questionnaire-based observational study of 32,559 women age 40 years or
older (Archives of Internal Medicine. 2006;166:760-765). Overall, the
latter report indicated a statistically significant increase in breast
cancer risk among black women. However, based on these self-reported data,
from women who used various preparations of estrogen, progestin, or
combination hormone therapy, and other information available in this paper,
it is difficult to interpret what these data may mean for postmenopausal
women of any race or ethnicity.
Wyeth believes all of these findings should be included as part of the
overall risk/benefit discussion between menopausal women and health care
professionals.
Wyeth continues to support the appropriate use of hormone therapy for
its approved indications -- the relief of moderate to severe menopausal
symptoms, such as hot flashes, night sweats and vaginal dryness, and the
prevention of postmenopausal osteoporosis -- and recommends that therapy be
taken at the lowest effective dose for the shortest duration consistent
with treatment goals and risks for the individual woman.
About the Women's Health Initiative
The WHI was a large-scale study sponsored by the National Institutes of
Health. It was designed to evaluate HT, dietary modification, calcium and
vitamin D as preventive therapies for postmenopausal women. The HT sub-
studies were designed to assess selected long-term risks and benefits of
PREMARIN(R) (conjugated estrogens tablets, USP) and PREMPRO(TM) (conjugated
estrogens/medroxyprogesterone acetate tablets). Wyeth provided the
medications used in the HT portion of the WHI study, but did not have a
role in the analysis or reporting of study findings.
The HT portion of the WHI study enrolled approximately 27,000 women
between 1993 and 1998. The estrogen-plus-progestin sub-study began with
more than 16,000 women randomized to estrogen-plus-progestin or placebo.
The estrogen-alone sub-study enrolled more than 10,700 hysterectomized
women.
The primary efficacy endpoint of WHI was the prevention of coronary
heart disease, and the primary safety endpoint was the risk of breast
cancer. The secondary endpoints included hip fracture, colorectal cancer,
stroke, pulmonary embolism and death from other causes.
The WHI was not designed to assess the relief of menopausal symptoms,
such as hot flashes, night sweats and dryness from vaginal atrophy -- the
primary reasons women initiate therapy.
The estrogen-plus-progestin study arm of the WHI concluded in July
2002; the estrogen-alone arm concluded in March 2004. Sub-study
participants were then asked to enter into a follow-up phase.
It is important to note that the estrogen-alone sub-study of WHI
evaluated the 0.625 mg strength of PREMARIN; today, a number of lower doses
of the PREMARIN Family of Products are widely available, including PREMARIN
0.3 mg and 0.45 mg and PREMPRO 0.3 mg/1.5 mg and 0.45 mg/1.5 mg.
About the PREMARIN Family of Products
Wyeth Pharmaceuticals is the leader in women's health, with a long
history of product innovation. Its low dose hormone therapies are part of a
family of well-studied products, which includes multiple strengths of
PREMARIN and PREMPRO. Currently taken by about 4 million women in the
United States, these products are prescribed more often than any other
brand of postmenopausal HT.
What is the most important information you should know about PREMARIN
(estrogens) or PREMPRO (a combination of estrogens and a progestin)?
- Estrogens increase the chances of getting cancer of the uterus.
- Report any unusual vaginal bleeding right away while you are taking
these products. Vaginal bleeding after menopause may be a warning sign
of cancer of the uterus (womb). Your health care provider should check
any unusual vaginal bleeding to find out the cause.
- Do not use estrogens with or without progestins to prevent heart
disease, heart attacks, strokes, or dementia.
- Using estrogens with or without progestins may increase your chances of
getting heart attacks, strokes, breast cancer, and blood clots. Using
estrogens, with or without progestins, may increase your risk of
dementia, based on a study of women age 65 years or older. You and your
health care provider should talk regularly about whether you still need
treatment with estrogens.
- PREMARIN is used after menopause to reduce moderate to severe hot
flashes; to treat moderate to severe dryness, itching, and burning, in
and around the vagina; and to help reduce your chances of getting
osteoporosis (thin, weak bones).
- PREMPRO is used after menopause in women with a uterus to reduce
moderate to severe hot flashes; to treat moderate to severe dryness,
itching, and burning, in and around the vagina; and to help reduce your
chances of getting osteoporosis (thin, weak bones).
- PREMARIN and PREMPRO should be used at the lowest effective dose and for
the shortest duration consistent with your treatment goals and risks.
If using PREMARIN or PREMPRO only to treat your symptoms of vaginal
dryness, consider topical therapies first. If you do not have symptoms,
non-estrogen treatments should be carefully considered before taking
PREMARIN and PREMPRO solely for the prevention of postmenopausal
osteoporosis.
- In a clinical trial, the most commonly reported (>/= 5%) side effects
that occurred more frequently with PREMARIN than with placebo were
vaginitis due to yeast or other causes, vaginal bleeding, painful
menstruation, and leg cramps.
- In a clinical trial, the most commonly reported (>/= 5%) side effects
that occurred more frequently with PREMPRO 0.45 mg/1.5 mg and PREMPRO
0.625 mg/2.5 mg than with placebo were breast pain/enlargement,
vaginitis due to yeast or other causes, leg cramps, vaginal
spotting/bleeding, and painful menstruation. In a clinical trial, there
was no difference in the commonly reported (>/= 5%) side effects for
women taking PREMPRO 0.3 mg/1.5 mg compared to those taking placebo.
- PREMARIN and PREMPRO should not be used if you have unusual vaginal
bleeding, have or had cancer of the breast or uterus, had a stroke or
heart attack in the past year, have or had blood clots, have liver
problems, are allergic to any of the ingredients in PREMARIN or PREMPRO,
or think you may be pregnant. In general, the addition of a progestin
is recommended for women with a uterus to reduce the chance of getting
cancer of the uterus.
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, cardiovascular disease, central nervous
system, inflammation, transplantation, hemophilia, oncology, vaccines and
nutritional products. Wyeth is one of the world's largest research-driven
pharmaceutical and health care products companies. It is a leader in the
discovery, development, manufacturing and marketing of pharmaceuticals,
vaccines, biotechnology products and non-prescription medicines that
improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort
Dodge Animal Health.
The statements in this press release that are not historical facts are
forward-looking statements based on current expectations of future events
that involve risks and uncertainties including, without limitation, risks
associated with the inherent uncertainty of the timing and success of
pharmaceutical research, product development, manufacturing,
commercialization, economic conditions including interest and currency
exchange rate fluctuations, changes in generally accepted accounting
principles, the impact of competitive or generic products, trade buying
patterns, wars or terrorist acts, product liability and other types of
lawsuits, the impact of legislation and regulatory compliance and obtaining
reimbursement, favorable drug pricing, access and other approvals,
environmental liabilities, and patent, and other risks and uncertainties,
including those detailed from time to time in the Company's periodic
reports, including current reports on Form 8-K, quarterly reports on Form
10-Q and the annual report on Form 10-K, filed with the Securities and
Exchange Commission. Actual results may vary materially from the
forward-looking statements. The Company assumes no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
* The Gail Risk Score incorporates age, history of benign breast
disease, age at menarche, age at first live birth, race/ethnicity, and
number of relatives (mothers and sisters) with breast cancer.
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