(I-Newswire) March 27, 2005 - Newly published data from the Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) Study now provide specific information about the percentages of individual postmenopausal women who experienced gains in bone mineral density (BMD) at the spine and the hip when taking low doses of PREMARIN® (conjugated estrogens tablets, USP) or PREMPRO™ (conjugated estrogens/medroxyprogesterone acetate tablets) for the relief of moderate to severe menopausal symptoms. The Women's HOPE Study evaluated four low dose options: PREMARIN 0.3 mg, PREMARIN 0.45 mg, PREMPRO 0.3 mg/1.5 mg, and PREMPRO 0.45 mg/1.5 mg. The newly published data can be accessed on the Web site for Osteoporosis International, the journal of the International Osteoporosis Foundation.
Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE), believes these data are important because up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. Postmenopausal bone loss can lead to osteoporosis.
According to Robert Lindsay, MD, PhD, the lead author of this new report and Director, Clinical Research Center, Helen Hayes Hospital, these data add important new information about bone protection with low doses of PREMARIN or PREMPRO.
"While previous research has shown the overall change in BMD for the population studied, this study goes further by documenting the percentage of women taking low doses of PREMARIN or PREMPRO who are likely to experience BMD gains," said Dr. Lindsay. "This information may be important when making treatment recommendations for women with menopausal symptoms who are also at risk of developing osteoporosis."
The Women's HOPE Study is a prospective, randomized, double-blind, placebo-controlled, multicenter trial of 2,673 healthy postmenopausal women (40 to 65 years of age). The new report is based on a 2-year substudy of 822 Women's HOPE Study participants that evaluated the effects of various doses of PREMARIN (conjugated estrogens [CE]) and PREMPRO (conjugated estrogens [CE]/medroxyprogesterone acetate [MPA]) on BMD. Participants were randomized to one of eight treatment groups (all doses mg/day): 0.625 CE, 0.45 CE, 0.3 CE, 0.625 CE/2.5 MPA, 0.45 CE/2.5 MPA, 0.45 CE/1.5 MPA, 0.3 CE/1.5 MPA, or placebo. BMD at the spine and hip were measured at baseline, 12 months, and 24 months.
At 24 months, women taking low doses of either PREMARIN or PREMPRO showed significant gains in spine BMD compared with women taking placebo. The percentages of women with an increase in spine BMD on low dose therapy ranged from 63.2% to 79.1% compared with 17.7% for placebo. By dose, the percentages were 63.2% for PREMARIN 0.3, 67.8% for PREMPRO 0.3/1.5, 74.2% for PREMPRO 0.45/1.5, and 79.1% for PREMARIN 0.45. The percentage of women taking PREMARIN 0.625 and PREMPRO 0.625/2.5 who experienced increases in spine BMD was 81.9% and 87.7%, respectively.
Increases in hip BMD were also observed for women on hormone therapy (HT) versus placebo. The percentages of women with an increase in hip BMD at 24 months ranged from 65.5% to 76.9% compared with 43.5% for placebo. By dose, the percentages were 65.5% for PREMARIN 0.3, 73.0% for PREMPRO 0.3/1.5, 76.4% for PREMPRO 0.45/1.5, and 76.9% for PREMARIN 0.45. The percentage of women taking PREMARIN 0.625 and PREMPRO 0.625/2.5 who experienced increases in hip BMD was 76.5% and 76.0%, respectively.
"Menopause is an important time for a woman to see her physician and evaluate her overall health," says Gary L. Stiles, MD, Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "While women can feel the effects of vasomotor symptoms, such as hot flashes, they may not be aware that they are also at risk of bone loss, which can lead to postmenopausal osteoporosis."
With more than 60 years of science and clinical experience with PREMARIN, there is an extensive catalogue of data documenting the benefits and risks of the PREMARIN family.
Both the American College of Obstetricians and Gynecologists (ACOG) and the North American Menopause Society (NAMS) have recently issued guidance confirming the role of estrogen and estrogen plus progestin as appropriate first-line therapies for the prevention of osteoporosis in women with menopausal symptoms. ACOG, NAMS, and other women's health experts agree that estrogen and estrogen plus progestin therapies are highly effective for the alleviation of moderate to severe hot flashes and night sweats and are effective agents for preventing postmenopausal osteoporosis.
The benefits and risks of HT should be discussed between a woman and her doctor before initiating therapy.
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 alone, 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 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 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.
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 nonprescription 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.
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Chris Garland
Wyeth Pharmaceuticals
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