Wyeth says study data shows no increased risk of breast cancer with conjugated estrogens alone

By Lisa Kerner

Erie, Pa., April 11 - Wyeth Pharmaceuticals, a division of Wyeth, said that data published in the Journal of the American Medical Association showed that in the estrogen-alone sub-study of the Women's Health Initiative, conjugated estrogens 0.625 mg did not increase breast cancer incidence in postmenopausal women.

The Women's Health Initiative was a large-scale study sponsored by the National Institutes of Health to evaluate HT, dietary modification, calcium and vitamin D as preventive therapies for postmenopausal women.

Wyeth provided the medications used in the HT portion of the study, but did not have a role in the analysis or reporting of study findings, according to a company news release.

The HT sub-studies, assessing long-term risks and benefits of Premarin (conjugated estrogens tablets, USP) and Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), enrolled approximately 27,000 women between 1993 and 1998.

The primary endpoint was the prevention of coronary heart disease, with the primary safety endpoint of breast cancer risk, the company said.

The research was not designed to assess the relief of menopausal symptoms, such as hot flashes, night sweats and dryness from vaginal atrophy.

Wyeth said the study authors 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.

"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," Wyeth Pharmaceuticals vice president, women's health care and bone repair, Ginger Constantine said in the release.

"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."

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.

Additional analyses showed that women who consistently took conjugated estrogens as prescribed had a statistically significant decrease in breast cancer risk compared to women taking placebo, the company said.

Wyeth, based in Madison, N.J., discovers, develops, manufactures and markets pharmaceuticals,

vaccines, biotechnology products and non-prescription medicines.

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