ADVANCE/The North American Menopause Society Updates Position Statement on Estrogen and Progestogen Use in Peri- and Postmenopausal Women

CLEVELAND--(BUSINESS WIRE)--Sept. 29, 2004--

EMBARGOED until October 5, 2004

“Recommendations for estrogen and progestogen use in peri- and postmenopausal women: October 2004 position statement of The North American Menopause Society”

The so-called "bioidentical hormones," custom-made formulations of alternatives to FDA-approved estrogen and progestogen drugs, should be considered to have the same safety issues as those associated with traditional postmenopausal hormone therapy (estrogen alone or for women with a uterus, estrogen plus progestogen) until clinical trials can specify the safety and effectiveness of these products, according to a revised position statement on use of postmenopausal hormone therapy from The North American Menopause Society (NAMS).

"It's important to recognize that even though different compounds have different characteristics, in the absence of specific trial data, risks must be generalized to all agents in this class," said Wulf H. Utian, MD, PhD, NAMS Executive Director and Chair of the Hormone Therapy Advisory Panel that developed the paper for approval by the NAMS Board of Trustees. "Bioidentical hormones are not a kinder and gentler version of traditional hormone therapy."

The third annual report, titled "Recommendations for estrogen and progestogen use in peri- and postmenopausal women: October 2004 position statement of The North American Menopause Society," contains several other significant revisions based on clinical trial data published in the past year. The paper will be distributed to attendees of the NAMS 15th Annual Meeting, held October 6-9 in Washington, DC, and posted on the NAMS Web site (www.menopause.org) on October 5. It will also be published in the Nov/Dec 2004 issue of the Society's official journal, Menopause.

In each of the last three years, NAMS has convened a Hormone Therapy Panel composed of experts in many fields to review newly published studies and to determine whether recommendations need revised or if new recommendations need to be added.

The following are some of the significant revisions contained in the 2004 document:

-- Stressed that estrogen or estrogen-progestogen therapy (ET/EPT) can still be considered together with alternate drugs for reducing osteoporosis risk.

-- Placed no limit on ET/EPT treatment duration, provided it is consistent with treatment goals and is monitored regularly; no stipulation was made regarding when to reduce or stop therapy.

-- Revised the breast cancer statement to indicate that the risk of breast cancer probably increases with EPT use but not ET use.

-- Noted that the role of both ET and EPT in the primary prevention of coronary heart disease (ie, preventing the disease from occurring) remains unclear, especially in younger women starting therapy early and continuing for a number of years; however, until that evidence is forthcoming, no ET or EPT regimen should be used for primary or secondary prevention of coronary heart disease.

-- Expanded the introduction to explain the terminology used to define and interpret risk and encourage utilization of international standards to quantify risk.

-- Added a statement in the introduction that no single trial should be used to set public health policy. The practice of medicine must ultimately be based on the interpretation of the entire body of evidence currently available, given that there will never be adequate clinical trials to cover all populations, eventualities, and regimens.

This year's position statement also retains many of the same recommendations made in the previous report, including the following:

-- The strong endorsement to use ET/EPT for management of menopause-related symptoms, such as hot flashes.

-- Use of ET or EPT should be limited to the lowest effective dose and the shortest duration consistent with treatment goals, benefits, and risks for the individual woman.

NAMS is North America's leading nonprofit organization dedicated to promoting women's health during midlife and beyond through an understanding of menopause. The Society's unique multidisciplinary membership of more than 2,000 includes experts from medicine, nursing, sociology, psychology, anthropology, pharmacy, epidemiology, nutrition, education, and basic science - helping NAMS to be the preeminent resource on all aspects of menopause to healthcare providers and the public. Its multidisciplinary membership of menopause experts also makes NAMS uniquely qualified to provide menopause-related information that is accurate, well-balanced, and presented without bias. For more Society information, contact the NAMS Central Office at [phone] or visit the NAMS Web site (www.menopause.org).

(End of advance for release 12:01 a.m. ET October 5, 2004.)