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David Baxter PhD

Late Founder
Hormone Heart Risks Overstated for Some
April 4, 2007

CHICAGO (AP) -- Maybe hormones aren't so bad for women's hearts after all -- if the women are still in their 50s. In a postscript to a landmark study five years ago that led millions of women to abandon hormones during menopause, a new review suggests the heart risks for this group of women were overstated.

In fact, hormones probably are a reasonable short-term option for women in their 50s who need relief from hot flashes, night sweats and other symptoms, said Dr. Jacques Rossouw, the government researcher who led the original research and the new review of the high-profile Women's Health Initiative

The pills -- either estrogen alone or a combination of estrogen-progestin -- don't get a complete stamp of approval because of stroke risks for both and breast cancer risks for the combination pill.

But many critics of the original study feel vindicated. They had argued that the results were skewed because more than half the women in the study were well past the usual age when hormone users start treatment.

"If you go back to the original WHI results, women were too old, they had too much disease, there was no breakdown by years or time since menopause," said Dr. Debra Judelson, a Beverly Hills cardiologist. The new analysis attempts to clarify those points, she said, and "has got tremendous benefit."

"Hormone therapy is an individualized choice. This actually should help women and doctors to make that kind of decision," said Dr. Joseph Camardo of Wyeth Pharmaceuticals Inc., maker of the hormone pills studied.

The new analysis indicates the pills don't raise the risk of heart attack for women in the 50-to-59 age group. However, that age group did see a higher risk of breast cancer from the combination hormone and a higher risk for stroke from that pill and estrogen alone. The risk was even greater for older women. That's because women in their 70s or who are 20 years past menopause already face increased heart, stroke and cancer risks by virtue of age alone.

Rossouw of the National Heart, Lung and Blood Institute called the new results "somewhat reassuring."

Dr. Deborah Grady, a researcher at the University of California at San Francisco, said many women and doctors overreacted to the initial study data and the re-analysis may help temper some of the aversion to hormones that followed.

"Hormone therapy in women who are near menopause is probably not very dangerous," Grady said, noting that previous analyses of the study data also hinted at that.

However, concerns remain about the higher risk for breast cancer, which turned up in the original study of estrogen-progestin pills. So the general advice for hormones remains the same: Use them only to relieve symptoms, at the lowest effective dose for the shortest possible time, Rossouw said.

The report appears in Wednesday's Journal of the American Medical Association.

The original study results in 2002 sent a shock wave across the country for women using hormones. The study of more than 16,000 women ages 50 to 79 using estrogen-progestin or dummy pills for an average of about five years indicated that heart attack, stroke and breast cancer risks outweighed any benefits.

More bad news came two years later with data showing an increased stroke risk with the estrogen-only pill.

Annual U.S. prescriptions for estrogen-progestin pills plummeted from 20.7 million in 2001, the year before the first study results, to 4.3 million last year. Prescriptions for estrogen-only pills dropped from 42.6 million in 2001 to 14.2 million last year, according to IMS Health data provided by Wyeth.

Hormone supporters questioned the initial results because of the abundance of women participants past their 50s. Some also doubted the results because they conflicted with long-standing beliefs that hormones could help prevent heart disease and many other ills of aging, based on less rigorous research.

In their new analysis, the researchers broke down the results by age and length of time since menopause. They analyzed the estrogen and estrogen-progestin study groups separately. But because there were relatively few bad outcomes in the youngest women, they also combined the results from both those groups to give the data more statistical strength.

These analyses focused on heart attacks and stroke. Rossouw said a more detailed re-analysis of breast cancer data by age is planned.

Intriguingly, the combined analysis showed that women in their 50s on hormones were less likely to die over the seven-year study period than those taking dummy pills; there were 69 deaths among hormone users versus 95 among women on dummy pills. There also was a hint of reduced mortality in the separate analyses of the two types of pills. The researchers are further analyzing the data to determine causes of death and what might explain those findings, said co-author Dr. JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital.

"Overall, the findings suggest that timing does matter when it comes to the benefit-to-risk profile of hormone therapy," she said.
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