Healthcare Industry News: osteoporosis
News Release - May 8, 2006
Wyeth Comments on New Report From The Nurses' Health Study Published Today in the Archives of Internal MedicineMADISON, N.J., May 8 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), reports that data from the Nurses' Health Study (NHS) published today in the Archives of Internal Medicine show no increase in invasive breast cancer risk among postmenopausal hysterectomized women who used estrogen alone therapy for less than 10 years. Additionally, there was a nonsignificant increase in breast cancer risk among women who used estrogen therapy for 10 to 19.9 years, and a significant increase in breast cancer risk among women who used estrogen therapy for 20 or more years. Few women in the NHS study population used doses lower than 0.625 mg of estrogen.
The NHS researchers also reported a nonsignificant decrease in breast cancer risk among current estrogen therapy users for 5 to 9.9 years. These data are consistent with the recent findings on estrogen therapy and breast cancer that were published from the Women's Health Initiative (WHI) Estrogen Therapy (ET) sub-study.
"The NHS findings, in addition to recent WHI study findings on breast cancer, are very important for millions of women who are appropriate candidates for estrogen-alone therapy," says Ginger Constantine, MD, Vice President, Women's Health Care and Bone Repair for Wyeth Pharmaceuticals. "Women should ask their health care professional about how these findings relate to their individual health."
While there are differences in the duration of the studies -- the NHS study followed women for more than 20 years, the WHI ET sub-study for about seven years -- it is important to note that the findings for the overlapping time periods are consistent. The NHS authors also noted that, as they expected, the association of increased risk with estrogen therapy seemed stronger for estrogen receptor positive/progestin receptor positive cancers (ER+/PR+). The designation of a tumor as ER+ refers to the potential for a tumor to respond to estrogen. This designation does not generally indicate the cause of a tumor. Findings about breast cancer risk and hormone use have been mixed. Some studies have reported an increased risk of breast cancer with hormone therapy. Other studies have not shown this increase, such as this WHI estrogen-alone sub-study.
Hormone therapy is a valuable treatment for millions of symptomatic postmenopausal women. It should be prescribed at the lowest effective dose and for the appropriate duration necessary for a woman to achieve her treatment goals, with consideration given to her individual risk profile.
About the Nurses' Health Study
The NHS is a large prospective cohort study of over 120,000 registered nurses in the United States. There were 11,508 women who had a hysterectomy and reported information on estrogen use at baseline in 1980. The study population was expanded every two years as NHS participants reported having a hysterectomy and becoming menopausal. By the final follow-up period (2000- 2002), there were 28,835 women being followed in the study.
About Estrogen-Alone Therapy
Both estrogen-alone and estrogen-plus-progestin therapy are indicated for the relief of moderate to severe menopausal symptoms, and the prevention of postmenopausal osteoporosis.
Estrogen-alone therapy is most commonly prescribed to treat menopausal symptoms and prevent osteoporosis in women who have had a total hysterectomy (surgery to remove a woman's uterus and ovaries). The abrupt changes in hormone levels following this surgery can cause a woman to experience the transition into menopause suddenly, rather than over the course of a few years. Post hysterectomy, many women experience sudden -- and often severe -- menopausal symptoms such as hot flashes, night sweats and vaginal dryness, and are at increased risk for bone loss.
Estrogen-plus-progestin therapy is used by women who have not had a hysterectomy. The role of the progestin is to protect the lining of the uterus from overstimulation by estrogen, which can lead to endometrial cancer. Hormone therapy -- either estrogen-alone or estrogen-plus-progestin -- should not be used to prevent CHD.
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 and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, 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, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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