Advice for the Patient Receiving or Considering Hormone Replacement Therapy

Menopause

Menopause is a normal part of aging for women. It is the time in a woman?s life when the ovaries no longer produce eggs and menstruation stops. During this ?change of life,? the amount of estrogen circulating in the body sharply declines, thus presenting a variety of symptoms and new health concerns. Menopausal symptoms include hot flashes, vaginal dryness, sleeplessness (perhaps due to hot flashes), and mood changes. Estrogen replacement alleviates these symptoms for many women.

Hormone replacement therapy (HRT) consists of estrogen alone (for women who have had a hysterectomy) or estrogen plus a progestin for women who have an intact uterus. HRT provides symptom relief in the majority of women who use it, and it has been associated with other positive effects, such as preventing bone loss and reducing the risk of colorectal cancer. As with any medication, however, there are also risks associated with HRT use, including a moderate increase in risk for breast cancer and blood clots.

Until recently, HRT has been used not only to treat menopausal symptoms, but also to prevent cardiovascular disease, osteoporosis, and colorectal cancer. Recent research, however, has indicated that estrogen-plus-progestin HRT should not be used for primary or secondary prevention of cardiovascular events. It is still indicated for symptoms associated with menopause and for prevention of osteoporosis in those women whose potential benfit outweighs potential risk. Therefore, it is important for health care providers and women together to evaluate the risks and benefits of using HRT and to understand when it is a good therapeutic choice for each individual woman.

Hormone Replacement Therapy in the News

The latest study of HRT found hormone therapy doubled the risk of Alzheimer?s disease and other forms of dementia in women who began the treatment at age 65 and older.(1)The findings are based on a 4-year trial involving 4532 women at 39 medical centers, part of the Women?s Health Initiative (WHI). Half of the participants took placebos, and half took Prempro (Wyeth Pharmaceuticals), a combination of estrogen and progestin. The results showed 40 cases of dementia in the hormone group, compared with 21 in the placebo group. For women 65 and older on hormone therapy, there would be 23 cases of dementia per 10,000 women annually, according to the study. Because the women in the study were 65 and older, it is not known if the findings apply to younger postmenopausal women or if the results apply to women who take other hormone combinations or estrogen alone.

Sally A. Shumaker, PhD, lead investigator of the study and researcher at Wake Forest University Health Sciences in Winston-Salem, NC, stressed the fact that women 65 and older taking Prempro or other hormone combinations should discuss the reason they are taking the drugs with their physicians and if they should quit. Researchers now advise that only women with severe menopausal symptoms such as hot flashes and night sweats take HRT and for the shortest time possible.

WHI was a large study involving about 160,000 healthy, postmenopausal women. The study was designed to clarify the role of HRT in the treatment of menopause. Specifically, the WHI study assessed the long-term effects of HRT on heart attack, stroke, blood clots, bone fractures, breast cancer, and colorectal cancer.(2)The most important facts about the WHI study are as follows:

• Premarin (0.625 mg of conjugated estrogens) was used for the estrogen-only group in the study. Prempro (0.625 mg of conjugated estrogens and 2.5 mg of medroxyprogester-one) was used for the estrogen-plus-progestin group. Therefore, results from this trial cannot be directly related to the use of other combination forms of HRT.
• Women enrolled in the WHI study who are taking Premarin (estrogen only) are still being evaluated.
• There were more cases of breast cancer, heart attacks, strokes, and blood clots in women taking estrogen plus progestin than in women taking sugar pills.
• There were fewer cases of hip fractures, other fractures, and colorectal cancer in women taking estrogen plus progestin than in women taking sugar pills.
• There were no differences between the 2 groups in the number of women who had endometrial cancer or the number who died.

What Does This Mean for Women?

If a woman has questions about whether HRT is appropriate for her, the pharmacist should counsel her to address these concerns with her physician. It is absolutely essential that a patient and her doctor work together to determine whether or not she should stop or start HRT. Every woman is unique, and her specific situation is different from that of her friends. The doctor should evaluate the woman?s risk for heart disease, osteoporosis, and certain cancers. For most women, relieving menopausal symptoms by taking HRT for short periods is safe and appropriate. It also is important for women to adjust their lifestyle to make menopause as easy a transition as possible. They should be advised to quit smoking, increase their physical activity, eat healthy foods, and minimize stress in order to decrease menopausal symptoms. Adopting healthy habits also allows women to lower their risk for certain diseases that are more likely to occur after menopause.

If a woman and her doctor decide that it is appropriate for her to stop HRT, the dosage should be tapered before discontinuation so that she does not have rebound symptoms. Once she has stopped HRT, the patient and her doctor should discuss the symptoms she may have and discuss other ways to treat those symptoms.

Alternatives to HRTLifestyle changes are the first step to minimizing hot flashes. Dressing in layers of clothing that can be removed, sleeping in a cool room, and avoiding hot and spicy foods are some of the ways to avoid hot flashes. If, however, a woman does start to experience a hot flash, she should be advised to breathe slowly and deeply to lessen the effect. Cold, caffeine-free beverages also may help. For vaginal dryness, lubricants and moisturizers can provide relief and are available without a prescription.

Soy and isoflavones contain plant-derived estrogens, or ?phytoestrogens,? which have estrogen-like activity. Phy-toestrogens have been shown to relieve hot flashes in some women, and soy may improve bone density. Because phytoestrogens act at the same receptor as estrogen, however, they may confer the same risks as do prescription estrogen therapies. Whole soy foods?such as soybeans, soy flour, soy milk, tofu, and tempeh? are the preferred sources for isoflavones.

Nutritional supplements and herbal therapies for menopause may be useful in some women, but their safety and efficacy are not guaranteed or monitored by the FDA. A woman should talk to her physician before taking any nutritional supplement or herbal therapy.

A woman?s bone density may decrease significantly without estrogen in the years just after menopause. Calcium is important for the maintenance of bone density. According to the National Osteoporosis Foundation, most women consume less than half of the recommended daily allowance of elemental calcium, which is 1200 mg daily for women over age 50. If a woman?s diet is not rich in dairy products or other sources of calcium, she may be advised to take a calcium supplement. Because the body can absorb only about 500 mg of calcium at a time, calcium should be ingested throughout the day, not all at once.

Vitamin D also plays an important role in bone health by helping the body absorb calcium. The body produces vitamin D when skin is exposed to natural sunlight, and it is also available through diet. Adequate calcium and vitamin D intake, along with regular weight-bearing exercise, can help maintain existing bone density. Menopause is an appropriate time for a bone density test to be performed. Prescription medications can be used to prevent or treat osteoporosis as well.

The number-1 killer of women is heart disease. A woman should talk to her physician about having her cholesterol and blood pressure checked, as well as whether she is a good candidate for daily low-dose aspirin therapy to prevent blood clots. She should eat healthy foods, increase soluble fiber, and decrease saturated fat. Regular exercise and avoiding tobacco use reduce the risk for heart disease.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. D. Ryan, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: dryan@mwc.com.