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Risks of Long-Term Hormone Therapy Continue to Outweigh Benefits

Women still at risk after they stop using HRT

March 6, 2008

Hormone Replacement Therapy • Risks of Long-Term Hormone Therapy Continue to Outweigh Benefits • FDA Warns Makers of 'Bio-Identical' Hormone Replacement Therapy • HRT May Prevent Heart Attacks In Some Women • FTC Warns Hormone Replacement Therapy Promoters

Even though they stopped using combination (estrogen plus progestin) hormone therapy several years ago, healthy, postmenopausal women are still at risk for stroke, blood clots, and cancer.

New results from the Women's Health Initiative (WHI) confirm that such risks clearly outweigh the benefits of the therapy.

Researchers report that about three years after women stopped taking combination hormone therapy, many of the health effects of hormones such as increased risk of heart disease are diminished, but risks of the other ailments remains high.

"The good news is that after women stop taking combination hormone therapy, their risk of heart disease appears to decrease," noted Elizabeth G. Nabel, M.D., NHLBI director. "However, these findings also indicate that women who take estrogen plus progestin continue to be at increased risk of breast cancer, even years after stopping therapy.”

The FDA recommends that hormone therapy never be used to prevent heart disease, and, when it is used for menopausal symptoms, it should only be taken at the smallest dose and for the shortest time possible.

The main estrogen-plus-progestin study was stopped in 2002 after an average of 5.6 years of treatment due to an increase in breast cancer. Women on combination hormone therapy also were at increased risk of stroke, blood clots, and heart disease, while their risk of colorectal cancer and hip fractures was lower, compared to women who did not take hormone therapy.

The follow-up study began in July 2002 after women in the study were instructed to stop taking combination hormone therapy, and continued through March 2005, with participants followed for an average of 2.4 years.

All study participants were examined at least once a year by a WHI clinician and received an annual breast examination and mammogram, with biopsies performed as needed.

During the follow-up study, the numbers of heart attacks, strokes, and blood clots were not significantly different between the two groups (overall, 343 cardiovascular events among those who initially received hormone therapy versus 323 among those who did not).

In addition, the number of deaths was not significantly different (233 women who had been in the hormone therapy group died, versus 196 women who had been in the placebo group).

"After being on combination hormone therapy for several years, the women's risk of cardiovascular disease was significantly higher -- from a 29 percent increase in heart attacks to a 41 percent increase in strokes and nearly twice the risk of serious blood clots -- compared to the women who did not take hormones," said Michael S. Lauer, M.D., director of the NHLBI Division of Prevention and Population Sciences.

"While it is reassuring that heart attack risk decreased and that the risks for stroke and blood clots did not grow after the women stopped taking hormones, this study provides further evidence that five years of combination hormone therapy is harmful. All the accumulated risks do not simply disappear," he added.

The study also found that other effects of combination hormones, such as decreased risk of colorectal cancer and hip fractures, also stopped when therapy ended.

"We continue to encourage women to use hormones only if needed for menopausal symptoms, and for the shortest time possible, and to adopt and maintain a healthy lifestyle, that is, engage in regular physical activity, maintain a healthy body weight, consume a diet low in saturated fat, and to not smoke, to reduce their risks of cardiovascular and other chronic diseases," said Marcia Stefanick, Ph.D., professor of medicine at Stanford University, Stanford, Calif., and a coauthor of the paper, as well as chair of the WHI Steering Committee.

She added that women should know their cholesterol and blood pressure levels and other health risks and take preventative measures, as needed.

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