ENDO: Society Calls for New Look at Hormone Therapy

  • by News Editor, MedPage Today

Action Points

  • Explain to interested patients that new evidence suggests the benefits and risks of hormone therapy depend on a woman's age when the therapy is started as well as the number of years since she began menopause.
SAN DIEGO -- The risks and benefits of initiating postmenopausal hormone therapy may vary depending on the age of the patient and the length of time since menopause, according to a scientific statement released by the Endocrine Society.

New data indicate that women ages 50 to 59 who start hormone therapy respond differently than women who begin taking hormones after age 60, Richard Santen, MD, of the University of Virginia, said at a press briefing at the society's annual meeting here.

And the length of time since menopause plays a role too, said Santen, who chaired the task force that developed the statement. "If you start a short time after menopause, the risks are different than if you start a long time after menopause."

In recent years, many physicians had stopped recommending hormone therapy to postmenopausal women based on data from the Women's Health Initiative (WHI) showing increased risks of heart disease, stroke, and breast cancer for women taking hormone therapy.

However, Santen said, the average age of the women in the WHI was 63. Only 3.4% of women in the study were ages 50 and 55, "the usual time when women would decide to take hormone therapy," he said.

To develop the statement, the 12-member task force recruited 25 experts to review literature in their areas of expertise. They each prepared a summary of the evidence, which was peer-reviewed by another expert and then by the task force as well as other reviewers.

One interesting finding, Santen said, was that women who start hormone therapy within 10 years of menopause have a 30% to 40% reduction in total mortality. "This is very surprising."

In addition, in the 50 to 55 age group the task force concluded that hormone therapy reduced hot flashes and overactive bladder and that vaginal estrogen reduced recurrent urinary tract infections. The evidence also showed that hormone therapy reduced pain on intercourse and improved quality of life, Santen said.

In terms of prevention, the task force found that in the 50 to 55 age group there were five fewer deaths per 1,000 women taking hormone therapy for five years, as well as 10 fewer diagnoses of diabetes, four fewer cases of heart disease, five fewer fractures, and two fewer cases of colon cancer.

Despite these benefits in the younger population, hormone therapy does still carry some risks for this group, he continued. These included stroke (an increase of two cases per thousand women taking hormone therapy for five years), blood clots in the legs and lungs (five more cases per thousand), gall bladder disease (10 more cases per thousand), and breast cancer (seven more cases per thousand).

Regarding the breast cancer cases, however, Santen noted that the task force reached an unusual preliminary consensus. "Our conclusion is that [the estrogen/progestin hormone combination] didn't cause breast cancer -- it caused preexisting tumors to grow to a size where they became detectable."

That conclusion is based on eight studies involving autopsies of women ages 40 to 80 to see how many were found to have had breast cancers too small to have been diagnosed. The studies found that about 7% of the women had undiagnosed breast cancer. Using that data and extrapolating to the patients in the WHI who developed breast cancer while taking the estrogen/progestin combination hormone therapy, the task force arrived at the figure of seven women per thousand, Santen said.

In older women, and in those who had had menopause more than 10 years earlier, the news was not as good. While women who initiated hormone therapy with only conjugated equine estrogen between the ages of 50 and 59 saw their risk of coronary heart disease events decrease by 37%, women ages 60 to 69 saw only a 6% drop, and women ages 70 to 79 saw a 13% increased risk, the task force reported.

Similarly, women who started estrogen-only hormone therapy less than 10 years after menopause had a 52% reduced risk of a coronary heart disease event, while those starting therapy 10 to 19 years after menopause had a 4% decreased risk, and those starting it 20 or more years after menopause had a 12% increased risk.

None of those numbers were statistically significant, but they did point to a general trend, Santen said.

The take-home message, he concluded, is that "physicians and patients need to rethink the use of menopausal hormone therapy based on these new data.

"The statement suggests a change in perspective and a need to consider the risks and benefits [of hormone therapy] for women actually considering its use."

The statement, released at the Endocrine Society meeting, will be published in the July issue of the Journal of Clinical Endocrinology & Metabolism.

No outside funding was used in preparing the scientific statement.

Santen is a consultant for Ipsen and Wyeth/Pfizer. He said the other authors also served as consultants but that a full list of disclosures was not available.

  • Reviewed by Zalman S. Agus, MD Emeritus Professor