New osteoporosis drug

CHICAGO (AP) — A new alternative to estrogen may offer older women many of the hormone’s heart and bone protections without its most worrisome side effect — an increased risk of breast cancer.
However, experts warned it is too soon to say whether the drug, raloxifene, is a “magic bullet,” with estrogen’s strengths and not its drawbacks.
Millions of women take estrogen to counter the effects of menopause, including thinning bones. But many refuse to take it because of its potential to increase the risk of breast cancer, and scientists have been searching for a substitute.
Raloxifene already is approved by the Food and Drug Administration to prevent osteoporosis in postmenopausal women, and research indicates it reduces the risk of breast cancer as well.
Now a study has found that raloxifene, like estrogen, might also protect the heart, researchers reported in Wednesday’s Journal of the American Medical Association.
“It potentially has promise to be a pathway to go beyond the estrogen dilemma,” said the lead author, Dr. Brian W. Walsh, director of the Menopause Center at Harvard-affiliated Brigham and Women’s Hospital in Boston.
The study found raloxifene lowered levels of “bad” cholesterol, or LDL cholesterol, by 12 percent in postmenopausal women, compared with 14 percent for estrogen. Raloxifene failed to improve the women’s levels of “good” cholesterol, or HDL, an important protector against heart disease. The drug also had much less of a favorable effect than estrogen does on a blood fat called lipoprotein-a.
The drug did, however, lower levels of a clotting protein called fibrinogen, another risk factor for heart disease, while estrogen did not.
The study involved 390 healthy, postmenopausal women at eight medical centers nationwide. Some were given standard hormone replacement therapy that included estrogen; some were given dummy pills; and some received raloxifene. The maker of raloxifene, Eli Lilly & Co., helped pay for the study.
Walsh said it is too soon to tell if raloxifene, marketed as Evista, will become an alternative to estrogen, the most commonly prescribed drug in America.
He said more study is needed to test whether raloxifene really does prevent heart disease, which kills almost seven times as many women as breast cancer in the 55-and-over age group.
“Where I think the drug will find it’s place is for women after they’ve gone through the menopause symptoms, when they’re older, and they’re more at risk for breast cancer, heart disease and osteoporosis,” Walsh said. “Raloxifene could protect them against those three conditions.”
Dr. Basil M. Rifkind, a senior adviser at the National Heart, Lung and Blood Institute, said he is not convinced. A recent study found raloxifene did not protect postmenopausal monkeys from developing heart disease, he noted. Estrogen did protect them.
No rigorous study has been done to measure whether raloxifene or even estrogen prevents heart disease in humans, although there is a lot of data to strongly suggest estrogen works, Rifkind said.
In the meantime, researchers said, women and their doctors will have to weigh the findings to date and the woman’s individual risks and concerns.
Raloxifene’s few side effects can include hot flashes or leg cramps. Estrogen is good at relieving hot flashes but also causes menstrual periods to resume in most women.