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Wyeth (WYE) Release: National Institutes of Health (NIH) State-Of-The-Science Panel Supports Use Of Hormone Therapy For Treatment Of Moderate To Severe Menopausal Symptoms


10/19/2005 5:13:06 PM

MADISON, N.J., March 23 /PRNewswire-FirstCall/ -- A panel meeting in conjunction with this week's Conference on the Management of Menopause-Related Symptoms, convened by the National Institutes of Health (NIH), has issued a statement supporting the use of postmenopausal hormone therapy (HT) for the management of moderate to severe menopausal symptoms, such as hot flashes, night sweats, and vaginal dryness. Wyeth Pharmaceuticals, a division of Wyeth , supports the panel's statement on the treatment of menopausal symptoms and encourages women experiencing menopause to talk with their doctor to determine treatment options as appropriate, based on an individual woman's treatment goals and personal health profile.

The NIH conference provided a forum for researchers and clinicians to discuss the physiologic causes of menopausal symptoms and a range of treatment interventions. Estimates vary, but most women going through menopause experience symptoms, such as hot flashes. These symptoms can have a significant negative impact on a woman's daily activities.

"The panel agreed that hormone therapy remains the most consistently effective therapy for treating menopausal symptoms and is, by far, the most intensively studied," said Dr. Gary Stiles, MD, Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.

While the NIH conference focused on menopausal symptoms, another important health issue for women is postmenopausal bone loss -- an asymptomatic condition that can lead to the development of osteoporosis. Up to 20 percent of a woman's expected lifetime bone loss can occur in the years immediately following menopause. Only HT has been proven both to relieve menopausal symptoms and to prevent postmenopausal osteoporosis.

Associations of women's health experts -- including the American College of Obstetricians and Gynecologists (ACOG), the North American Menopause Society (NAMS), the American Society for Reproductive Medicine (ASRM), and the International Menopause Society (IMS) -- agree that postmenopausal estrogen and estrogen plus progestin therapies are highly effective for the alleviation of moderate to severe hot flashes, night sweats, and vaginal dryness, and are also appropriate therapies for the prevention of postmenopausal osteoporosis in symptomatic women.

The benefits and risks of HT should be discussed between a woman and her doctor before initiating therapy. HT should be used at the lowest effective dose and for the shortest duration of time consistent with a woman's individual treatment goals and risks.

The panel discussed alternative therapies, such as bioidenticals and over- the-counter remedies, currently being used as potential treatment options for the relief of menopausal symptoms, but noted the paucity of safety and efficacy data.

With more than 60 years of science and clinical experience, there is an extensive catalogue of data documenting the benefits and risks of the PREMARIN(R) (conjugated estrogens) Family of Products. Products are available in multiple strengths, including four low doses options: Premarin(R) (conjugated estrogens tablets, USP) 0.3 mg, PREMARIN 0.45 mg, Prempro(TM) (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, and PREMPRO 0.45 mg/1.5 mg.

"Medicine and science continue to evolve, and Wyeth is committed to offering menopausal women and their health care providers innovative, well- studied products to meet individual treatment goals and risks," said Dr. Stiles.

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 (greater than or equal to 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 (greater than or equal to 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 (greater than or equal to 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.

Wyeth Pharmaceuticals

CONTACT: Media Contacts, Chris Garland, +1-484-865-6323; or CandaceSteele, +1-484-865-5428, both of Wyeth Pharmaceuticals; or Investor Contact,Justin Victoria of Wyeth, +1-973-660-5340



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