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Hormone Study Adds To Evidence of Danger

Women who use drugs show nearly double the risk of heart attack

Aug 6, 2003 | Milwaukee Journal Sentinel

New research from the nation's largest women's health study gives more evidence that taking hormones for even as little as a year after menopause could be dangerous.

The odds of having a heart attack nearly double in the first year on the drugs and stay higher with longer use than those for women not taking hormones, concludes the study, published today in the New England Journal of Medicine.

The risk applied to virtually all women, not just those with other risk factors, such as high blood pressure or a family history of heart problems.

Millions of women took estrogen and progestin for relief of hot flashes and other menopause symptoms and to prevent heart problems because earlier studies suggested that benefit.

Many went off the drugs last summer, when this landmark study was halted prematurely because researchers saw the opposite effect - a higher risk of breast cancer, heart problems and stroke among women on hormones.

Still, some women and their doctors considered relatively short-term use of the drugs to be safe. This is the third report from the landmark study suggesting otherwise. The others found that using hormones for as little as a year raised the odds of developing dementia, having an abnormal mammogram and having more advanced cases of breast cancer.

"Even women with high LDL ('bad') cholesterol had greater increase in risk" if they were taking hormones, said JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital and one of the leaders of the study, the Women's Health Initiative.

Local doctors said the newest study gives even more reason to not prescribe the drugs except to relieve severe symptoms during menopause, and for a very short time.

"What we have been telling women has drastically changed in the last 12 months. There are fewer patients we would advise to take hormone replacement therapy, certainly no women with cardiac history or cardiac family history. We're only using it for severe symptoms," said Tod Poremski, an obstetrician and gynecologist at St. Joseph Regional Medical Center.

"It's one of the most dramatic sea changes in clinical medicine," Manson agreed, but added: "Women should not be unduly alarmed by these findings."

Heart attack is still relatively uncommon, and the added risk posed by the hormones translates to six extra cases per 10,000 women per year, she said.

The study involved more than 16,600 women nationwide, including some at the Medical College of Wisconsin, where professor Jane Kotchen is leading Wisconsin's participation.

After one year of taking Prempro, by far the most popularly sold combination of estrogen and progestin, women on the drug had an 81% greater risk of heart attack than a control group of women not on the drug. After five years of use, the increased risk was 24% for those on hormone therapy.

"The clear message is it should not be used to prevent cardiovascular disease," Manson said.

She noted that the drugs never were approved by the Food and Drug Administration for preventing heart disease, just for relieving menopause symptoms and preventing bone loss.

In an editorial in the medical journal, David Herrington and Timothy Howard of Wake Forest University School of Medicine in Winston-Salem, N.C., said the drugs became wildly popular because of wishful thinking.

It "was easy for both patients and physicians to believe" that merely replacing hormones lost through normal aging would be good, and the desire to believe this is so great that even after the study was stopped last summer and harmful effects from hormones were revealed, 10% of women in the placebo group started taking them even though they didn't have severe hot flashes or osteoporosis and had been encouraged not to take the pills.

"The lesson is that belief, no matter how sincerely held, is no substitute for proof" from well done scientific studies, they conclude.

.

The odds of having a heart attack nearly double in the first year on the drugs and stay higher with longer use than those for women not taking hormones, concludes the study, published today in the New England Journal of Medicine.

The risk applied to virtually all women, not just those with other risk factors, such as high blood pressure or a family history of heart problems.

Millions of women took estrogen and progestin for relief of hot flashes and other menopause symptoms and to prevent heart problems because earlier studies suggested that benefit.

Many went off the drugs last summer, when this landmark study was halted prematurely because researchers saw the opposite effect a higher risk of breast cancer, heart problems and stroke among women on hormones.

Still, some women and their doctors considered relatively short-term use of the drugs to be safe. This is the third report from the landmark study suggesting otherwise. The others found that using hormones for as little as a year raised the odds of developing dementia, having an abnormal mammogram and having more advanced cases of breast cancer.

"Even women with high LDL ('bad') cholesterol had greater increase in risk" if they were taking hormones, said JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital and one of the leaders of the study, the Women's Health Initiative.

Local doctors said the newest study gives even more reason to not prescribe the drugs except to relieve severe symptoms during menopause, and for a very short time.

"What we have been telling women has drastically changed in the last 12 months. There are fewer patients we would advise to take hormone replacement therapy, certainly no women with cardiac history or cardiac family history. We're only using it for severe symptoms," said Tod Poremski, an obstetrician and gynecologist at St. Joseph Regional Medical Center.

"It's one of the most dramatic sea changes in clinical medicine," Manson agreed, but added: "Women should not be unduly alarmed by these findings."

Heart attack is still relatively uncommon, and the added risk posed by the hormones translates to six extra cases per 10,000 women per year, she said.

The study involved more than 16,600 women nationwide, including some at the Medical College of Wisconsin, where professor Jane Kotchen is leading Wisconsin's participation.

After one year of taking Prempro, by far the most popularly sold combination of estrogen and progestin, women on the drug had an 81% greater risk of heart attack than a control group of women not on the drug. After five years of use, the increased risk was 24% for those on hormone therapy.

"The clear message is it should not be used to prevent cardiovascular disease," Manson said.

She noted that the drugs never were approved by the Food and Drug Administration for preventing heart disease, just for relieving menopause symptoms and preventing bone loss.

In an editorial in the medical journal, David Herrington and Timothy Howard of Wake Forest University School of Medicine in Winston-Salem, N.C., said the drugs became wildly popular because of wishful thinking.

It "was easy for both patients and physicians to believe" that merely replacing hormones lost through normal aging would be good, and the desire to believe this is so great that even after the study was stopped last summer and harmful effects from hormones were revealed, 10% of women in the placebo group started taking them even though they didn't have severe hot flashes or osteoporosis and had been encouraged not to take the pills.

"The lesson is that belief, no matter how sincerely held, is no substitute for proof" from well done scientific studies, they conclude.


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