ADVANCE/Postmenopausal Hormone Therapy Revisited; the North American Menopause Society Releases Report From Advisory Panel On Use of Postmenopausal Hormone Therapy.

Business Editors, Health & Medical Writers

ADVANCE...for release 3:15 p.m. Oct. 3

(ADVANCE)CLEVELAND--(BUSINESS WIRE)--Oct. 3, 2002

Because of the findings from two recent large clinical trials on the use of hormone therapy (ie, estrogen plus a progestogen) by postmenopausal women, The North American Menopause Society (NAMS) has created a report on postmenopausal hormone use that provides analyses of the evidence and implications for clinical practice. The report is being presented Thursday, October 3, 2002, at the NAMS 13th Annual Meeting in Chicago, IL. The clinical trials -- the Women's Health Initiative (WHI) and the Heart and Estrogen/progestin Replacement Study (HERS) -- provided new knowledge that has altered the benefit-risk ratio for postmenopausal hormone therapy use, especially in women at risk for coronary heart disease (CHD).

"The findings from these studies have created a medical milestone in the course of women's health," said Margery L.S. Gass, MD, Panel Co-Chair and incoming NAMS President. "Clearly, there was a need for a consensus clinical opinion on the findings. This document presents the Society's expert interpretation of these findings and their application to everyday clinical practice."

The report was developed by a NAMS-appointed Advisory Panel, composed of healthcare professionals considered experts in specific areas of medical science related to the issues. In reaching conclusions, data from WHI, HERS, and other published studies of hormone use were considered. The report was reviewed and approved by the NAMS Board of Trustees. The full report can be viewed at the NAMS Web site (www.menopause.org).

"The NAMS Advisory Panel highlighted areas of consensus and areas of disagreement, with the latter in turn spotlighting urgent research needs," said Wulf Utian, MD, PhD, Panel Co-Chair and NAMS Executive Director.

In the report, the panelists also noted that in published data from HERS and WHI, only one hormone therapy was used, a popular estrogen-progestogen therapy for women with an intact uterus -- conjugated equine estrogens (0.625 mg/day) plus medroxyprogesterone acetate (2.5 mg/day). The trials used only one route of administration (oral) and only one regimen (daily administration of both hormones, a regimen called continuous-combined estrogen-progestogen therapy). Neither trial evaluated perimenopausal women or women with early menopause (ie, 40-50 years of age) or premature menopause (ie, less than 40 years of age).

The recommendations (ie, areas of consensus) are as follows:

-- Treatment of menopause symptoms (eg, vasomotor and urogenital) remains the primary indication for estrogen plus progestogen therapy (EPT) and estrogen therapy alone (ET).

-- The only menopause-related indication for chronic progestogen use appears to be endometrial protection from unopposed estrogen therapy. For all women with an intact uterus who are using estrogen therapy, clinicians are advised to prescribe adequate progestogen, whereas women without a uterus should not be prescribed a progestogen.

-- No EPT regimen should be used for primary or secondary prevention of coronary heart disease (CHD). Proven alternate cardioprotective regimens should be considered. The effect of ET on CHD is not yet clear. Until confirming data are available, ET should not be used for primary or secondary prevention of CHD.

-- Many EPT and ET products are FDA-approved for the prevention of postmenopausal osteoporosis; however, because of the risks associated with these forms of therapy, alternatives should also be considered, weighing the risks and benefits of each.

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

-- Lower-than-standard doses of EPT and ET should be considered.

-- Alternate routes of administration of EPT may offer advantages, but the long-term benefit-risk ratio has not been demonstrated.

-- An individual risk profile is essential for every woman contemplating any regimen of EPT or ET. Women should be informed of known risks.

No consensus could be reached on the acceptable definition of short- and long-term therapy, how long to prescribe hormone therapy for symptom relief, potential preventive reasons for extended hormone therapy, whether premature menopause or premature ovarian failure represent an indication for preventive EPT or ET, how best to discontinue therapy, and whether the results from the WHI and HERS trials should be generalized to other estrogens and progestogens, routes of administration, dosages, and regimens. Recommendations for areas of future research are provided in the report.

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 NAMS at 440/442-7550, or visit the NAMS Web site (www.menopause.org).

(End of advance for release 3:15 p.m. Oct. 3)