Osteo Drug Won't Harm Heart
Study: Evista even lowers risk for women likeliest to have problems
TUESDAY, Feb. 19, 2002 (HealthDayNews) -- The newest entry in the hormone replacement therapy field doesn't increase the risk of heart disease in post-menopausal women, and even appears to help women at high risk for heart attack and stroke.
A new study reports the good news about raloxifene, marketed as Evista. It is the first member of a family of new drugs called selective estrogen receptor modulators. These medications act differently than estrogen, the hormone typically prescribed to prevent osteoporosis, the bone-thinning condition that is common after menopause.
Hormone replacement therapy (HRT) has been suspected of increasing the risk of heart attack and stroke. It has been hoped that raloxifene would not carry that risk because it inhibits the effect of estrogen on most tissues of the body. A large-scale study of 10,000 women is under way to see if that is so, but those results are not expected for several years.
The new evidence on raloxifene and heart disease comes from an analysis of data from an earlier study that examined the effect of the drug on osteoporosis.
A team headed by Dr. Elizabeth Barrett-Connor, a professor of family and preventive medicine at the University of California at San Diego, looked at the data on cardiovascular disease -- heart attack, stroke and the like -- among 7,705 women in that study. The results appear in tomorrow's issue of the Journal of the American Medical Association.
Overall, Barrett-Connor says, there was no effect on cardiovascular risk. However, there was a 40 percent reduced incidence of adverse effects among a subset of 1,035 women with risk factors such as diabetes, smoking, high blood pressure and other conditions.
"We're a bit surprised to find an effect, because it was a relatively small number of women," Barrett-Connor says. "But this is fairly convincing data."
Eli Lilly and Co., maker of Evista, sponsored the study. Barrett-Connor has served as a consultant for the company; four of the other study authors are Lilly employees.
One comforting result is the analysis found no increased risk of cardiovascular events, Barrett-Connor says: "It is reassuring that it is not harmful."
However, she adds, the analysis must be verified by the new, larger study. "Until we confirm the finding, we can't be sure," she says.
Amy Alinn, program and policy director of the National Women's Health Network, an organization that has criticized HRT, is even more cautious.
"Only by playing with the data did they find a cardiovascular benefit," Alinn says. "The data on hormone replacement therapy (HRT) in general is too preliminary to claim that there is a strong risk, and experience with raloxifene is preliminary."
In addition, it is "equally significant that they did not find a benefit," Alinn says. "This is a group of relatively healthy women in which they should have found a benefit." However, like Barrett-Connor, she says it is encouraging that no overall increased cardiovascular risk was detected.
The story is still being told, Barrett-Connor says. The new analysis is based on a relatively short study, and "it might be that if the women were treated longer, there could be a benefit."
What To Do
A decision on HRT -- whether it is needed and which therapy is best -- should be made after a woman talks with her doctor.