Healthcare Industry News:  osteoporosis 

Biopharmaceuticals

 News Release - February 13, 2006

New Data from Women's Health Initiative Study Show No Increased Risk of Coronary Heart Disease with Conjugated Estrogens Alone In Any Age Group Studied

Data Suggest Lower Coronary Heart Disease Risk Among Women Aged 50-59

MADISON, N.J., Feb. 13 (HSMN NewsFeed) -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), reports that data published today in the Archives of Internal Medicine showed that in the estrogen-alone arm of the Women's Health Initiative (WHI) study, conjugated estrogens 0.625 mg therapy did not increase the risk of coronary heart disease (CHD) in women aged 50 to 79 after an average of 7.1 years. Study investigators also concluded that there was a suggestion of lower coronary heart disease risk with conjugated estrogens among women 50 to 59 years of age. These data are particularly interesting because this younger age group most closely resembles the typical patient treated with hormone therapy.

"This new information is important for many women taking or considering postmenopausal estrogen therapy to relieve the symptoms of menopause and/or to prevent osteoporosis," says Lila Nachtigall, MD, New York University School of Medicine. "These findings, coupled with other recent data, support the emerging belief that the age of the woman and time since menopause should be considered when assessing the overall benefit and risk of hormone therapy."

This most recent analysis of WHI data follows a January 2006 report published in the Journal of Women's Health, in which researchers from the Nurses Health Study (NHS), a large observational trial, reported a significant reduction in CHD among women who initiated hormone therapy (HT) early in menopause. The NHS data support the premise that timing of therapy may influence CHD risk.

"Both studies clearly show no increased risk of coronary heart disease with estrogen-alone therapy, and help clarify the individual assessment of risk and benefit," says Ginger Constantine, MD, Vice President, Women's Health Care and Bone Repair, Wyeth Pharmaceuticals. "This new information may be reassuring to millions of women who currently take, or are appropriate candidates for, estrogen-alone therapy."

"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. It is important to note that estrogen therapy, with or without a progestin, should not be used for the prevention of coronary heart disease," concludes Dr. Constantine.

The WHI estrogen-alone study evaluated 10,738 women age 50 to 79 years (mean age 63 years) who had previously had a hysterectomy. In the latest report, reflecting analyses of the final, adjudicated data, the WHI investigators concluded that in the overall study population conjugated estrogens 0.625 mg therapy did not increase CHD risk (RR 0.95; 95% CI 0.79-1.16). Furthermore, study investigators did not observe increased CHD risk in any of the subpopulations analyzed. In one of the planned sub-analyses by age, however, the investigators reported a statistically significant (34%) lower risk for the combined endpoint of myocardial infarction (heart attack), coronary death, coronary revascularization and confirmed angina among women who were between the ages of 50 and 59 at the start of the study (RR 0.66; 95% CI 0.45-0.96).

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 PREMPROTM (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 CHD, 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 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.

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 (greater than or equal to 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 (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 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 (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 to reduce the chance of getting cancer of the uterus.

About Wyeth Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), 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.


Source: Wyeth

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