Healthcare Industry News: osteoporosis
News Release - April 11, 2006
New Data From the Women's Health Initiative Study Show No Increased Risk of Breast Cancer with Conjugated Estrogens AloneData Suggest Possibility of Decreased Incidence of Breast Cancer for Some Women
MADISON, N.J., April 11 (HSMN NewsFeed) -- 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® (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.
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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