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WEDNESDAY, Aug. 6, 2003 (HealthDayNews) -- Two new studies offer more evidence that hormone replacement therapy (HRT) does not treat or prevent heart disease.
In one study, hormone therapy failed to slow the progression of atherosclerosis -- a buildup of fatty deposits in the arteries -- in women who already had the condition.
And according to findings from the second study, part of the Women's Health Initiative (WHI), hormone therapy poses the greatest risk of heart attack during the first year of use.
Neither of the studies, which appear in the Aug. 7 issue of the New England Journal of Medicine, should be interpreted to mean that short-term hormone therapy is not useful for treatment of menopausal symptoms such as hot flashes, the researchers say.
But, adds Dr. JoAnn Manson, one of the principal investigators of the WHI, "this means that the role of hormone therapy is much more limited than previously thought. Hormone replacement therapy is not a treatment or prevention option for heart disease."
Nor should the studies be interpreted to mean that women should only focus on heart health during and after menopause, doctors say.
"Heart disease for women is not just a menopausal issue. It's about early diagnosis, early prevention, to ultimately make a woman healthy before she's in menopause so she'll be healthier as she goes through menopause," says Dr. Nieca Goldberg, a cardiologist at Lenox Hill Hospital in New York City and author of Women Are Not Small Men.
"It's important for us to get away from HRT as the tonic for preventing and treating heart disease in postmenopausal women. We have so many good therapies that are proven to help women," she adds.
The original purpose of hormone therapy was to ease symptoms of menopause, including hot flashes, night sweats and disturbed sleep. When observational data indicated it might also reduce the risk of coronary heart disease, more women signed up for treatments.
The WHI, designed by U.S. researchers to look at potential approaches to prevention of assorted diseases in postmenopausal women, included a section devoted to hormone therapy. The HRT part of the trial was halted several years early, in July 2002, after women taking estrogen combined with progestin were seen to have a higher risk for heart attacks, cardiovascular disease, heart disease and breast cancer. Although the women also had a lower risk of colorectal cancer and fractures related to osteoporosis, the benefits did not outweigh the risks, the researchers concluded.
Data from the WHI study is still coming in, while other researchers continue to do independent studies on the risks and benefits of hormone therapy.
The first study reported in the journal was not part of the WHI. It involved 226 postmenopausal women who had already started to develop atherosclerosis, the build-up of fatty material along the inner walls of the arteries. The condition can lead to heart attacks and strokes and is responsible for one of every two deaths in the United States. This study, called the Women's Estrogen-Progestin Lipid-Lowering Hormone Atherosclerosis Regression Trial, or WELL-HART, was a randomized, double-blind, placebo-controlled trial, considered the gold standard in science.
Participants were randomly divided into three treatment groups, one receiving only estrogen, one taking both estrogen and progestin and those receiving "usual" medical care without hormones. The average age of the participants was almost 64 and they were about 18 years beyond menopause.
After approximately three years of follow-up, the study authors found no significant differences in the progression of atherosclerosis (measured by narrowing of the coronary artery) between the three groups. It's important to note that the women in the study already had clear signs of atherosclerosis.
The WELL-HART data do not necessarily contradict a sister study, called the Estrogen in the Prevention of Atherosclerosis Trial, or EPAT, which found that estrogen on its own did slow the progression of atherosclerosis in younger women who did not already have the disease.
"This all relates to a very important hypothesis about where hormones may be very active and beneficial, which is the time when women enter the transition into menopause," says Dr. Howard N. Hodis, lead investigator of the WELL-HART study and a professor of medicine and preventive medicine at the University of Southern California's Keck School of Medicine.
Although not proven yet, Hodis says, "the data [are] highly consistent that the timing of the hormonal replacement in relation to the stage of atherosclerosis is very important in whether one is going to receive a benefit or no benefit."
"We need to understand the early initiation of hormone therapy versus the late initiation in relation to menopause," Hodis says. "That is the ultimate question that needs to be answered."
The second study presented in the journal represents new analysis from the Women's Health Initiative, which involved 16,608 postmenopausal women aged 50 to 79 when the study started. The participants were randomly assigned to receive estrogen plus progestin or a placebo.
The women in the hormone therapy group had an 81 percent increased risk of heart attack during the first year of taking HRT, compared to the women not taking the hormonal regimen. The absolute numbers were quite low, however, and translated into 42 women who had a heart attack or died of coronary heart disease in the hormone group and 23 in the placebo group during that first year.
"The greatest risk is during the first year and then it returns to baseline," says Manson, who is chief of preventive medicine at Brigham and Women's Hospital in Boston.
Although the risk appeared to be fairly even, women with higher LDL ("bad") cholesterol levels and women who were more than a decade beyond menopause seemed to have an even higher risk of heart disease, the study found.
Dr. Wulf H. Utian, executive director of the North American Menopause Society, does point out some potential methodological problems with the study. Namely, the age range of the women was fairly wide, which might have skewed the results.
But doctors add these findings do not mean that hormone replacement therapy will or should go the way of the dinosaur.
"There's still a role for hormone therapy in the short-term treatment of menopausal symptoms," Manson says. Although that might mean a risk of heart disease in some women during the first year of treatment, the research suggests the overall risk would still be low.
"If you are going to have a clear benefit for the treatment of hot flashes and night sweats and disturbed sleep, then that may be the price," she says. "It is important to be under the care of a doctor and to have risk factors identified and treated."
Adds Utian: "I think the glass is half full. This is reassuring if the woman is highly symptomatic and needs help. If we do a good job of screening people at high risk, the chance [of developing heart disease] is really quite low."