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Another Blow To Hormone Therapy


Aug 6, 2003 | Mercury News

Researchers say women taking a leading combination hormone therapy for menopause face nearly double the risk of a heart attack in the first year of use a finding sure to dismay millions of American women who've been told that hormones are still safe if taken short-term.

These final results from the Women's Health Initiative, a lengthy federal study of hormone therapy, could prove to be the fatal blow to the long-held but increasingly battered belief that hormones help prevent heart disease.

In a study published in today's New England Journal of Medicine, women taking an estrogen-progesterone medication known as Prempro were 81 percent more likely to have a heart attack in the first year than women taking placebo pills. The risk fell to 24 percent after five years of use.

The absolute risk of a heart attack is small, researchers caution: In the study, five of every 1,000 women on hormones suffered a heart attack compared with three of every 1,000 women on placebo pills. A woman's individual risk of heart attack also depends greatly on her weight, whether she smokes and her family's history of heart disease. The study also does not apply to women who take estrogen only.

Still, findings like these are unnerving to Marge Howell, a San Jose Medical Center administrator who last year stopped her decadelong regimen of combination hormone therapy ``cold turkey'' because of mounting evidence of its risks.

``Gulp. That's scary that the risk is in the first year,'' said Howell, who is 60. ``When it comes to your heart or breast cancer, no one's willing to take a chance. As you get older, you really start worrying more: Will I be that one in a thousand?''

Prescribing changes

In the past year, doctors have been advised to prescribe the lowest possible doses of hormones for the shortest possible time, and then only to women experiencing severe menopause symptoms such as hot flashes and mood swings. Women who already are at risk for a heart attack, such as those with a family history of heart disease, high cholesterol or blood pressure, or who are overweight, may be strongly urged to avoid hormones altogether.

Ironically, physicians were once encouraged to prescribe hormones specifically to help stave off heart disease, today's leading cause of death in American women.

Once prescribed to millions of women as a ``fountain of youth'' that would help prevent heart disease, breast cancer, wrinkles and brittle bones, hormones have largely been discredited as preventive medicine and should be used only to treat severe hot flashes and other unbearable menopause symptoms.

That's in part because of the federally-sponsored Women's Health Initiative, which followed more than 16,000 women aged 50 to 79 for more than five years. The initiative's study of combination hormone therapy was halted in July 2002, when researchers found small but unacceptably high rates of breast cancer, as well as heart attacks and strokes, among participants on hormones.

Later analyses showed that the therapy also can increase the risk of Alzheimer's disease and other forms of dementia. However, other initiative studies on the effects of estrogen alone continue, with the jury still out on its benefits and risks.

``I think hormone therapy has a more limited role than previously believed what might be viewed as a vanishingly small role,'' said the study's lead author, Dr. JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston and a professor at Harvard Medical School.

The Women's Health Initiative's preliminary results on heart attacks, published last year, showed an overall increase in heart attack risk of nearly 30 percent, compared with women on placebo pills. Although researchers at the time believed much of that risk occurred early in use, they also speculated that hormones might help certain groups of women. That wasn't the case.

``The risks clearly exceed the benefits, and these analyses show that's true for just about every group we look at,'' said Dr. Marcia Stefanick, a Stanford University obstetrician/gynecologist and a Women's Health Initiative researcher.

Study findings

In the current New England Journal of Medicine study, researchers found 190 heart attacks, 39 of them fatal, among 8,506 women taking Prempro, compared with 148 heart attacks, 34 of them fatal, among 8,102 women taking placebo pills. The risk affected women regardless of their age, weight and other factors, and was even greater for older women and women with high cholesterol levels.

Although Prempro appeared to lower ``bad'' cholesterol and raise ``good'' cholesterol in some women, it didn't matter because the overall heart attack risk was so high compared with women taking placebos, said Stefanick, who has published other initiative results but did not help author the New England Journal of Medicine study.

Dr. Meg Durbin, an internist at the Palo Alto Medical Foundation, said more than half her patients have quit hormone therapy, and she makes sure every patient is aware of its risks.

``If it were up to me, they'd all drop it,'' Durbin said. ``But there are women who are completely, legitimately miserable off hormones, and they're feeling guilty because now they have to worry about these new risks.''

In the future, doctors may commonly prescribe non-hormonal antidepressants to alleviate mood swings. Effective drugs for osteoporosis are already on the market. But hot flashes remain a scientific challenge, said Stefanick. Scientists are now researching therapies such as black cohosh for these sweaty, debilitating spells, but hormones remain the most effective treatment.

``What a woman has to figure out,'' Stefanick said, ``is whether her symptoms are worth the risk."

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