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http://www.nytimes.com/2002/07/03/health/03HORM.html

Hormone Therapy Study Finds Risk for Some

By DENISE GRADY

ormone replacement does not prevent heart attacks — or related problems — in older women with heart disease, researchers are reporting. In addition, the treatment increases the risks of blood clots and gallbladder disease, they say.

But they report no link between hormone treatment and any form of cancer.

The new findings, described today in The Journal of the American Medical Association, confirmed and extended the results of a study published in 1998, the Heart and Estrogen/progestin Replacement Study, or HERS.

"For women with heart disease, there were harms, and zero benefit," said Dr. Deborah Grady, who led the new study.

Dr. Grady is director of the University of California San Franciso/Mount Zion Women's Health Clinical Research Center.

The results mean that women with heart disease cannot expect hormone replacement to prevent heart attacks or strokes or stop the progression of artery disease, the researchers said.

Instead of undergoing hormone replacement therapy, such women should be treated with drugs that have been shown to prevent heart attacks, like aspirin, beta blockers, ACE (angiotensin-converting enzyme) inhibitors, other blood pressure drugs and medicines that lower cholesterol in the blood. The same approach was recommended a year ago by the American Heart Association.

Days before The Journal was published, groups that support some uses of hormone therapy issued statements citing limitations of the study's findings, saying they do not apply to most women approaching menopause, because the women in HERS had an average age of 67 and a diagnosis of heart disease.

A doctors' group, the American Society for Reproductive Medicine, issued a statement that said for women in early menopause, hormone replacement was the best way to relieve menopausal symptoms like hot flashes and prevent bone loss, "with minimal risk of side effects."

The group added, "The HERS study is not relevant for this younger patient population."

Wyeth, the company that makes Premarin, the most widely used form of estrogen replacement, issued a similar statement.

The American College of Obstetricians and Gynecologists said the HERS study did not determine whether hormone treatment could prevent heart disease in younger, healthier women. "Answers on this issue will have to come from other research studies," the group said.

Dr. Wolf Utian, executive director of the North American Menopause Society, said that if a woman had been using hormones for several years without problems, there was no reason to discontinue them, even if she had heart disease. The HERS study, Dr. Utian said, might frighten women "into walking away from therapy that for them as individuals might be beneficial."

Dr. Grady agreed that for younger postmenopausal women with severe symptoms like hot flashes and night sweats, hormone replacement was the most effective treatment.

But she said she was skeptical of the idea that hormones might eventually be proved to prevent heart disease in healthy women. Her reason, she said, was that medical treatments that prevented disease always helped treat it or slow it as well. Since hormone therapy does not help women who already have heart disease, there is little reason to think it can prevent the disease or to prescribe it for that purpose, she said.

The original HERS study included 2,763 women, who were studied for 4.1 years. The women were assigned at random to take either placebos or daily doses of estrogen (0.625 milligram) and a synthetic form of the hormone progesterone, a progestin (2.5 milligrams). The estrogen was Premarin.

The findings suggested that women who took hormones had a higher risk of heart attacks and other cardiovascular problems in the first year, and a decreased risk after the third year. Over all, there was no benefit to hormone treatment.

The results came as a surprise to many researchers. Earlier studies had suggested that hormone therapy could prevent heart disease, so some scientists thought it should also be able to slow the progression of pre-existing disease.

When the treatment did not help women who already had heart disease, some researchers said it was because those women were different from healthy ones, and it was simply too late for them.

But other researchers said the HERS findings cast doubt on the earlier studies that had suggested that hormones prevented heart disease. Those studies were observational, meaning that the women in them had decided on their own whether or not to take hormones, instead of being assigned at random to a treatment or placebo group.

Observational studies are generally not considered as reliable as research in which participants are picked at random to be treated or not, because people who take preventive medications may have underlying differences from those who do not, like healthier lifestyles.

A decline in the rate of heart attacks after the first year of hormone therapy suggested that eventually, the women on hormones might wind up with a lower rate of heart attacks than women not taking hormones.

To determine whether that occurred, the researchers kept studying the women. The study published today, HERS II, included 2,321 of the original women, and followed them for another 2.7 years.

The rates of heart attack and other heart problems evened out, so that there was no difference between the groups. There were 290 heart attacks or coronary deaths in the hormone group, and 293 in the placebo group.

But hormone users had a doubling of the risk of blood clots in the legs and lungs, mostly in the first few years of the study. Forty-nine women in the hormone group experienced such problems, compared with 24 in the placebo group. The rate of gallbladder disease needing surgery also increased, by about 45 percent, with 125 cases in the hormone group, and 86 in the placebo group.

Dr. Grady said the adverse effects on clotting and gallbladder disease probably applied to younger, healthier women as well.

"There is no reason in the world why the adverse effects won't generalize," she said.

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