What about the new low-dose hormone patch, Menostar® (estradiol), that is used to prevent osteoporosis?

Menostar (estradiol) was FDA-approved in 2004 for the prevention of postmenopausal osteoporosis. It is a dime-sized transdermal patch that delivers about 14 micrograms of estrogen per day. A new patch is applied every week. Because your body absorbs the estrogen from the patch through the skin, you can avoid the liver "first-pass" effect, meaning that the hormone is not metabolized through your liver. Instead, it can go directly into the bloodstream.

The estrogen that is used in this patch is estradiol, one of the three estrogens made by the human body. Estradiol is the one in greatest abundance until menopause. Then levels drop off to near zero. Although estrone, another of the three estrogens, continues to be circulated in both men and women, it is not sufficient in quantity to prevent bone loss. Estradiol in Menostar is derived from plants but is bioidentical to the estradiol in the human body, meaning it is the exact, or identical, chemical structure as the estradiol made by your body. While manufactured estradiol is a bioidentical hormone, it still carries with it the same risks and benefits of other manufactured estrogens that have been studied more completely, such as conjugated equine estrogens. (See Questions 64 and 66 for further discussion of the risks and benefits of taking estrogen.)

The blood levels of estrogen resulting from Menostar are high enough to preserve bone. Research shows that Menostar is also effective for treating vasomotor symptoms associated with menopause. Menostar is not FDA-approved for vasomotor symptom treatment, and since it is such a low dose, some women may need higher estrogen doses to manage their individual symptoms. The blood levels of estrogen generated by hormone therapy that is usually used to treat vasomotor symptoms are two to eight times higher than those generated by Menostar.

If you are postmenopausal and want to prevent osteoporosis, or if you have osteopenia and you want to prevent further bone loss, Menostar may be appropriate for you. Menostar is not FDA-approved for osteoporosis treatment. Other treatment options are used instead.

Like all estrogen preparations that are of sufficient strength to raise blood levels, contraindications to Menostar include breast cancer or any estrogen-dependent cancer, history of stroke or heart attack (myocardial infarction), abnormal uterine bleeding, and a history of or current blood clot(s). Table 16 summarizes Menostar.

There is a lot of controversy about taking estrogen. Why is that? Should I accept the risks of being on it so that I can prevent further bone loss?

When the WHI estrogen-progestin (the participants were taking PremPro) arm of the study was halted in 2002, media concentrated on what causedresearchers to stop the study prematurely. The researchers found that the risk of breast cancer, stroke, cardiovascular events, and clots outweighed the benefits of fewer colorectal cancers and fewer hip fractures. In 2004, the estrogen-only arm of the study was also stopped prematurely, but not because of the risk of breast cancer. The researchers determined that the risk of stroke and clots was high enough to warrant stopping the study 1 year earlier than planned.

The increased risk of getting breast cancer while taking daily EPT (0.625 mg of conjugated equine estrogens and 2.5 mg of medroxyprogesterone) was reported as 26%. But that kind of statistic is more alarming than helpful. Using the WHI study's design and results, one could predict that of 10,000 post-menopausal women who were taking a placebo, 30 of them would develop breast cancer. If you looked at 10,000 postmenopausal women who were taking EPT

Table 16 Menostar (estradiol)

Menostar (estradiol)

for 5 or more years, 38 of them would develop breast cancer. The difference between 30 and 38 represents a 26% increase, but still only 8 more women out of 10,000 would develop breast cancer. If you happen to become 1 of the 8 (or 38 total), it's an important statistic to consider when making a decision. However, the media tended to jump on the increased risk of breast cancer; many women, when hearing this news, stopped their hormones cold-turkey. Many clinicians stopped prescribing hormones entirely.

After much more analysis of the WHI data as it applied to the EPT arm, there was more discussion among researchers and clinicians. Three points of view tended to develop from further analysis and discussion. One viewpoint was that the study was faulty in its design and conclusions, so we should not pay attention to the results. For example, the women who took part in the WHI study were well into their postmenopausal years and did not have significant vasomotor symptoms. Questions arise from this observation. Do women earlier in postmenopause develop the same risks? Because breast cancer takes as long as 7 years to develop, another question arises: Is it fair to attribute increased breast cancer risk to taking EPT for only 5 years? The second viewpoint was more absolute. No one should go on hormones, or hormones would have to be the last resort for treatment of menopausal symptoms. The third viewpoint falls somewhere in the middle, that the WHI brought important information to light about hormones but that there is still a place for the use of hormones in the treatment of the moderate-to-severe symptoms of menopause.

The controversy has not stopped. The estrogen-alone arm of the WHI showed a small decrease in the risk of breast cancer, which raised questions about the role of progestins in the development of breast cancer. More recently, there was an analysis of many studies in which women used ET or EPT. The result of looking at all of those data showed that estrogen is still an important treatment option for moderate-to-severe menopausal symptoms, and that the risk of death from heart disease or cancer was not increased when MHT is started in the early postmenopausal years. The WHI data were reanalyzed to look at effects for women in various age groups and found similar results. Younger women, who had just passed through menopause, did not have the increased risks for heart disease that were seen among older women. These results have shifted thinking again, and many more clinicians are now prescribing MHT for women immediately after menopause. MHT, like any medication, should be used in the lowest dose and for the shortest period of time possible.

The decision to use MHT can be a difficult one. With regard to your bones, you should not take it for the treatment of bone loss unless you have moderate-to-severe hot flashes or night sweats that require treatment. The smallest dose that will help your symptoms should be used. Any estrogen used orally or transdermally (by cream, gel, spray, mousse, or patch) will improve your bone density. Using vaginal estrogen for vaginal dryness will probably not provide you with enough estrogen to protect your bones, unless you use a vaginal estrogen ring such as Femring (estradiol). The Menostar patch protects your bones and may also treat your vasomotor symptoms.

Although MHT can prevent postmenopausal osteoporosis and is often used together with bisphosphonates or calcitonin, it is not an approved treatment for established osteoporosis. You should use other non-estrogen medications if you already have osteoporosis. When the long-term effects of estrogen therapy were compared with those of Fosamax (alendronate), improved BMD persisted longer in women taking Fosamax. Table 16 (Question 65) describes Menostar and Table 17 summarizes other estrogen therapies.

Before taking MHT, you should consider the possible benefits such as menopausal symptom management (including vasomotor symptoms, vaginal dryness, sleep and mood disturbances), osteoporosis prevention, and reduced risks for colon cancer as well as potential risks, including breast cancer, heart disease or stroke, and blood clots. Here are some questions to consider:

• What is the severity of my symptoms? How frequently do they occur? Do they interfere with my work or enjoyment of the activities of daily living?

• Have I kept track of things that bring on symptoms and tried to eliminate them (e.g., stopped eating chocolate if it brings on a hot flash)?

• Am I willing to make changes in my lifestyle to reduce my symptoms?

• What changes have I made in my lifestyle to reduce my symptoms?

• Am I trying to live in healthier ways (e.g., quit smoking)?

• What am I not willing or able to do at this time to modify my life? What is available to help for the short term and the long term?

• In addition to lifestyle changes, have I tried using vitamins and mineral supplements to help with my symptoms?

Table 17 Estrogen Therapies: Part 1, General Information; Part 2, Specific Products

Estrogen Therapies: Part 1, General Information; Part 2, Specific Products

• Do I have any medical conditions that would make it unsafe for me to go on MHT? Am I taking any medications that would interact badly with MHT?

• If I go on hormones, what would be the best route of administration for me? Will I be able to develop a regimen of remembering to take pills? Will I be willing to change patches? Will I be willing to apply vaginal cream or insert a vaginal ring?

• Will I be comfortable knowing that there are risks to taking estrogen and progesterone? Do I understand that all medications, vitamins, herbs, and supplements carry certain risks?

• Do I understand the benefits of estrogen in addition to relieving menopausal symptoms, such as reducing the risk of bone loss and colon cancer?

• Do I understand the side effects of hormone therapy? Do I understand that the hormones may relieve one symptom but that I may get another symptom as a result of the hormones?

• If I took hormones and I stopped having severe hot flashes, how happy would I be? If hormones could relieve the symptoms, do I think my life would be much better?

• Do I understand that taking hormones does not mean that I will get breast cancer? And do I also understand that avoiding hormones does not prevent me from getting breast cancer?

Once you have decided to use MHT for your vasomotor symptoms and your bone health, you should make sure the following questions are answered before you leave with your prescription:

• How long will I be on this drug?

• What symptoms should I report to my clinician?

• When does my clinician want to see me again?

• What are the options if I choose not to take this drug?

• How long will it be before I notice any improvement or change?

• What side effects or symptoms should I watch for? How can I minimize or prevent these symptoms?

• Will side effects or symptoms decrease with time?

• If I don't like taking it, should I let my clinician know I have stopped it?

• What do I do if I miss a dose?

• What if I go out of town and leave my prescription at home? Will it be a problem if I miss a week? A month?

• Is there a specific time of day I should take my medications?

• Will MHT interact with other medications that I'm taking?

• Are there other nonprescription medicines, herbs, or dietary supplements that I should not take with MHT?

• Can I still drink alcohol?

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