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Hormone Replacement Therapy

But Many Who Stop Estrogen Don't Get Other Bone Protection

More than half of women think hormone replacement therapy (HRT) is worth the risk. But many women who stop HRT aren't getting needed bone protection, a pharmacy survey shows.

By now, almost everyone knows that combination HRT with Prempro or Premphase means increased risk of breast cancer, heart disease, stroke, and blood clots. The risk is small but statistically significant. It appeared to outweigh the drugs' benefits: fewer bone fractures, fewer colon cancers, and fewer menopausal symptoms.

The news led many women to drop HRT. How many? Raulo S. Frear, PharmD, and colleagues took a look. The researchers work for Express Scripts Inc., a pharmacy benefit management company. Using the company's data, they looked at prescription patterns before and after the results of the two most recent large U.S. trials on HRT became public.

The findings:

57% of women on Prempro or Premphase continued their treatment.
36% of women stopped using Prempro or Premphase.
22.6% of women stopped taking estrogens altogether and did not start taking drugs to prevent bone loss.

"The number remaining on estrogen is high," Frear tells WebMD. "In the future, people will continue to use these drugs, although maybe more for the short term to get through hot flashes and other really bad symptoms of menopause."

What alarms Frear is how many women stopped taking estrogen and did not start taking drugs to prevent osteoporosis. Drugs commonly prescribed for this are the Fosamax , Actonel, and Evista, which prevent bone absorption.

"There are great drugs for the prevention and actual treatment of osteoporosis," Frear says. "We hope those women simply discontinued estrogen on their own and that when they go back to their doctors they will get a prescription for osteoporosis."

That's extremely important, says Lawrence Phillips, MD, professor of endocrinology at Emory University School of Medicine. Phillips headed the Emory arm of the Women's Health Initiative (WHI), one of the major HRT studies. His remarks to WebMD reflect his own expert opinion but are not official WHI statements.

"Since postmenopausal women are at increased risk of osteoporosis, especially if they don't take estrogen, it is alarming if they are stopping HRT and are not replacing it with anything," Phillips says. "The risk of a fracture goes up year after year after year. ... It is likely that many postmenopausal women will need at least one drug to help decrease the risk of osteoporosis."

Phillips notes that there are several factors involved:

Data suggest that the increased risk of heart problems linked to HRT may be most likely to happen in the first years of treatment. Women who have taken HRT for five to 10 years without problems may have a lower risk of heart disease.
HRT lowers a woman's risk of bone fracture and improves her blood-fat profile.
HRT increases a woman's risk of breast cancer, and this risk increases with each year of treatment.

"Any woman who goes off HRT needs to work with her doctor to assess her risk of osteoporosis and to see if her lipids are placing her at risk of cardiovascular problems," Phillips says. "Doctors may need to consider treating the individual with medication -- separate medicines in this case -- to decrease a woman's risk of fracture and lipid-related cardiovascular disease."

So what does Phillips tell his menopausal and postmenopausal patients?

"I am proactive in my practice. I am switching women from Prempro and Premphase to other estrogens, especially an estrogen patch," he says. "But there aren't a lot of substitutes for the oral progestin. I am switching patients from the MPA progestin that was in Provera and Prempro to a more natural form of progestin, Prometrium, which still has to be taken as a pill."

Source: WebMD Medical News  
Monday, January 13, 2003

Progestin-Estrogen Therapy Debate Cools

Other Than Treating Menopause Symptoms, HRT Does Little to Improve Quality of Life

A cloud of confusion has surrounded HRT since last July, when women learned that hormones may cause health risks. Now, in an early release of more findings, researchers reveal that HRT does little to improve quality of life.

Their conclusion: Unless you need relief of menopausal symptoms, there's no benefit to taking combination progestin-estrogen therapy. The benefit of progestin-estrogen therapy must be weighed against the risk of such therapy for each individual.

Their study appears in the May 8 edition of The New England Journal of Medicine, accessed online on March 14. It is the second report issued since Women's Health Initiative (WHI) researchers reported an increased risk of heart attack, breast cancer, and stroke in women taking the combination progestin-estrogen therapy. Those findings prompted the NIH to halt the study nearly three years early.

Today's message: "For the vast majority of women, hormones do not change quality of life," lead researcher Jennifer Hays, MD, director of the Center for Women's Health at Baylor College of Medicine in Houston, tells WebMD.

In this second study, Hays and colleagues analyzed information on all 16,608 postmenopausal women -- all between 50 and 79 years old -- who had randomly been assigned to take either daily progestin-plus-estrogen therapy or placebo.

After one year, women were asked questions about their general health, mental and physical health, limitations due to their physical or emotional health, bodily pain, energy and fatigue, social functioning, depression, memory, sleep disturbance, and satisfaction with sexual functioning.

The results "shocked" Hays and her colleagues. "The differences between the two groups were almost imperceptible," she says. Only small differences in physical functioning, bodily pain, and sleep disturbances in women taking daily combination hormone replacement were found.

Researchers also analyzed data on quality of life in subgroups of women -- those who were youngest (between ages 50 and 59) and most likely to have menopause-related symptoms, and those who had reported the most severe hot flashes.

When looking at just the group of younger women, no substantial quality-of-life improvements were seen whether or not women had taken HRT.

When looking at women who reported moderate to severe hot flashes, one year of follow-up did show that 77% of women on HRT improved compared with only half of the women on placebo. Night sweats also improved significantly in women on the progestin-estrogen therapy.

What happened to their hot flashes? "It's partly placebo effect, but it's also the natural process of menopause," Hays explains. "Most women do not experience hot flashes five years after menopause. The symptoms do improve over time." She points out the "tremendous variability" among women in their menopausal experience. Some women simply have worse symptoms -- especially hot flashes -- than others. In fact, one study found women in their 70s who were still having hot flashes, she says.

Many women refused to be enrolled in the WHI study because they wanted to keep taking their hormones. "I heard women say, 'This study is so important, but do not take me off my hormones,'" Hays says. "Whether they could function without the hormones or not is another matter. They had the perception that they couldn't."

"I'm sure many women have benefited from HRT," she tells WebMD. "Women seek treatment because their symptoms are severe, very bothersome. So there may be some women these results don't apply to. Those are the women most in need of help. We don't want to invalidate the experience of those women."

More research of this major transition in women's lives is needed, says Hays. "There's no such thing as the average woman. There are variations in physical and emotional experiences during this time."

"You should take hormones if you need them," says Laura Corio, MD, a gynecologist at Mount Sinai Medical Center in New York and author of The Change Before The Change: Everything You Need to Know to Stay Healthy in the Decade Before Menopause.

"If you're having night sweats, hot flashes -- terrible symptoms -- you should take them to relieve symptoms," Corio tells WebMD. However, don't take them longer than necessary. "We're not keeping patients on combined therapy long term if there's no reason."

Quality of life is dependent on exercise, diet, and vitamins, Corio points out. "You don't take these hormones to give yourself energy and get better quality of life. They help more with hot flashes, joint pain, mood swings related to hormone changes. If depression is the problem, you need an antidepressant."

Other hormones can also help menopausal women. Natural progesterone can help build bone, help heart and brain, and help sleep disturbance, says Corio. Testosterone helps with energy, mood, libido, and memory.

Hays says her study's findings should be reassuring to women who discontinued estrogen therapy this past summer because they were worried about the risks, she tells WebMD. Menopause relief often usually comes naturally, she says. "If you hang in there, you will feel better."

Source: WebMD Medical News  
March 17, 2003