Lower Hormone Replacement Therapy Just as Effective

EMBARGOED until Monday, June 4, 2001

CONTACT: Abena Foreman-Trice, UVA Health System Media Relations, 804-924-5679 [email protected]

LOWER DOSE HORMONE REPLACEMENT THERAPY JUST AS EFFECTIVE AS OFTEN PRESCRIBED DOSES

CHARLOTTESVILLE, Va., June 4 -- Lower doses of hormone replacement therapy (HRT) are just as effective at reducing hot flashes and vaginal changes in postmenopausal women as currently prescribed doses, according to a study published in the June issue of Fertility and Sterility.

The Women's Health, Osteoporosis, Progestin, and Estrogen (HOPE) study, in which the University of Virginia Health System participated as a site, found that lower doses of conjugated equine estrogens (CEE) and medroxyprogesterone (MPA), an agent that protects the uterus against cancer, improve symptoms of menopause as effectively as commonly prescribed doses.

"This is exciting research," said Dr. JoAnn Pinkerton, director of the U.Va. Health System MidLife Center and coauthor of the HOPE study. "The results confirm the safety and efficacy of lower doses of estrogen. Women entering menopause will have the option of lower doses, which in this study were proven effective at relieving hot flushes and vaginal changes. The availability of lower doses should ease the fears of those who are concerned about the link between estrogen and breast cancer."

The double-blind study involved more than 2,000 healthy, postmenopausal women with intact uteruses. A group of 243 symptomatic women were measured by the number and severity of their hot flashes and their vaginal maturation index (VMI), which assesses vaginal changes.

The women were instructed to take two tablets - one was CEE or matching placebo, the other was a mixture of CEE and MPA.

After one year researchers found that the women taking .45 milligrams of CEE and 1.5 milligrams of MPA, and .3 milligrams of CEE and 1.5 milligrams of MPA had reduced numbers of hot flashes and vaginal changes, which were comparable to the currently prescribed dose of .625 milligrams of CEE and 2.5 to 5 milligrams of MPA.

Breast pain was found to be the most common side effect of the lower dose estrogen regimen. Importantly, however, less bleeding was found with the lower doses. Bleeding is a major reason why women discontinue HRT, Pinkerton said.

The HOPE clinical trials were supported by funds from Wyeth Laboratories. "The Food and Drug Administration is expected to approve a low dose HRT by the end of the summer," Pinkerton said. ###

June 1, 2001