Drug Uses
Evista is a prescription medicine used by women after menopause to treat or prevent a condition called osteoporosis. You should take calcium and vitamin D along with Evista if you do not get enough calcium and vitamin D in your diet.
How Taken
The recommended dosage is one 60-mg Evista tablet daily, which may be administered any time of day without regard to meals.
Warnings/Precautions
Before taking this medication, tell your doctor if you have a history of blood clots; stroke; cancer; increased triglycerides (a type of fat in the blood); or liver disease.
You may not be able to take Evista, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Evista is in the FDA pregnancy category X. This means that Evista is known to cause birth defects in an unborn baby. Do not take Evista if you are pregnant or if you could become pregnant during treatment.
It is not known whether Evista passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
Missed Dose
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
Possible Side Effects
An infrequent but serious side effect of taking Evista is the development of blood clots in the veins. These blood clots can stop blood flow and cause serious medical problems, disability or death. Call your doctor right away if you have or have had any of the following signs of blood clots in the legs, lungs or eyes: leg pain or a feeling of warmth in the calves, swelling of the legs, hands or feet, sudden chest pain, shortness of breath or coughing up blood, sudden change in your vision, such as loss of vision or blurred vision.
Most of the side effects of Evista are mild and usually do not cause women to stop taking Evista. The most common side effects of Evista are hot flashes and leg cramps. Hot flashes are more common during the first 6 months after starting treatment.
If you have any problems or questions that concern you while taking Evista, ask your doctor or pharmacist for more information.
Storage
Store at controlled room temperature, 20o to 25oC (68o to 77oF); allows excursions between 15o and 30oC (59o and 86oF).
Overdose
Incidents of overdose in humans have not been reported. There is no specific antidote for Evista.
More Information
Before having any surgery, tell your doctor that you are taking Evista. Treatment with Evista may need to be stopped temporarily if you require an extended period of bed rest.
Avoid sitting still for long periods of time during travel while taking Evista.
Alcohol and cigarette smoking may cause increased bone loss. Discuss with your doctor the use of these products.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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There are two leading reasons why people choose to obtain prescription drugs online. The first is cost. Due to the economics of health care in the United States, consumers often must pay a significantly higher price for medication than consumers in other countries. A second reason is privacy. Some people prefer to obtain Evista online, even at a higher cost, than to consult a doctor in person about issues such as depression, hair loss, or erectile dysfunction.
Q: What is your cancellation policy for Evista?
A: You may cancel your order before the order has shipped or been approved by the doctor. If the order has already been shipped or approved we cannot cancel your order. Please refer to the current cancellation policy in the terms & conditions section of our order page for more information.
Menopause
Key Points
• Menopausal hormone use (sometimes referred to as hormone replacement therapy or postmenopausal hormone use) involves taking either estrogen alone or estrogen in combination with progesterone or progestin, a synthetic hormone with effects similar to those of progesterone (see Question 2).
• Estrogen is prescribed to treat some of the problems often associated with menopause, such as hot flashes, night sweats, sleeplessness, and vaginal dryness. Doctors may also recommend hormones to prevent long-term conditions more common in postmenopausal women, such as osteoporosis (see Question 2).
• A recent large clinical trial showed that the health risks associated with estrogen plus progestin use were greater than the benefits (see Questions 4-11).
• The overall health effects of estrogen alone in postmenopausal women are less clear. The best evidence will come from a large ongoing clinical trial involving women taking estrogen alone, which is expected to end in 2005 (see Questions 4-11).
1. What is menopause?
Menopause is the time in a woman's life when menstruation ends. It is part of a biological process that begins, for most women, in their mid-thirties. During this time, the ovaries gradually produce lower levels of sex hormones–--–estrogen and progesterone. Estrogen promotes the development of a woman's breasts and uterus, controls the cycle of ovulation (when an ovary releases an egg into a fallopian tube), and affects many aspects of a woman's physical and emotional health. Progesterone controls menstruation (having a period) and prepares the lining of the uterus to receive the fertilized egg.
"Natural menopause" begins when a woman has her last period, or stops menstruating, and is considered complete when menstruation has stopped for 1 year. This usually occurs between ages 45 and 55, with variations in timing from woman to woman. Women who undergo surgery to remove both ovaries (an operation called bilateral oophorectomy) experience "surgical menopause"--an immediate end to hormone production and menstruation.
During menopause, a woman may experience problems such as hot flashes, night sweats, sleeplessness, and vaginal dryness. In addition, some long-term conditions, such as osteoporosis and coronary heart disease, are more common in women in the decades after menopause.
By the time the menopause transition is complete, hormone output has decreased significantly. Even though low levels of estrogen are produced by the adrenal glands and fat cells after menopause, they are only about one-tenth of the level found in premenopausal women. Progesterone is nearly absent in menopausal women.
2. What are menopausal hormones and why are they used?
Menopausal hormone use (sometimes referred to as hormone replacement therapy or postmenopausal hormone use) usually involves treatment with either estrogen alone or estrogen in combination with progesterone or progestin, a synthetic hormone with effects similar to those of progesterone.
Estrogen usage, with or without progestin, approximately doubles the estrogen level of a menopausal woman; however, even with hormone treatment, the estrogen and progesterone levels do not reach the natural levels of a premenopausal woman.
Doctors may recommend using hormones to counter some of the problems often associated with menopause (hot flashes, night sweats, sleeplessness, and vaginal dryness) or to prevent some long-term conditions that are more common in postmenopausal women, such as osteoporosis. Data from a 1997 national survey showed that 45 percent of U.S. women born between 1897 and 1950 used menopausal hormones for at least 1 month, and 20 percent continued use for 5 or more years.
3. How do scientists determine the health outcomes associated with hormone use?
In order to study the benefits and risks of hormone use, researchers commonly conduct two types of human studies: clinical trials and observational studies. In clinical trials, the participants are given either hormones or placebos (look-alike pills that do not contain any drug) to determine the effect of the hormones on various conditions and diseases. In observational studies, there is no intervention by the investigators; they compare the health status of women taking hormones to women not taking the hormones. The strongest evidence for proving an association between menopausal hormones and a disease or condition comes from clinical trials.
4. Do the benefits of hormone use after menopause outweigh the risks?
The best evidence for the risks and benefits of postmenopausal hormone use comes from the Women's Health Initiative (WHI), a large randomized clinical trial of over 16,000 healthy women ages 50 through 79, in which half of the participants took hormones and the other half took a placebo pill (which does not contain any drug). The trial, sponsored by the National Institutes of Health (NIH), was halted early when, in July 2002, investigators reported that the overall risks of estrogen plus progestin, specifically PremproTM, outweighed the benefits. The WHI found that use of this estrogen plus progestin pill increases the risk of breast cancer, heart disease, stroke, and blood clots. The study also found that there were fewer cases of hip fractures and colon cancer among women using estrogen plus progestin than in those taking a placebo.
Findings from the WHI Memory Study (WHIMS), reported in May 2003, showed that in older women, age 65 and above, use of estrogen plus progestin doubled the risk of developing dementia. These same women also did more poorly on cognitive function tests compared with those taking placebo.
Additionally, an analysis of the quality of life of a subgroup of WHI participants age 50 through 79 found no change in general health, vitality, mental health, depressive symptoms, or sexual satisfaction associated with use of estrogen plus progestin.
The risks and benefits of estrogen alone are less clear. The study of women in the WHI taking estrogen alone is scheduled to continue until 2005, and the results of this trial will provide evidence for the associated health effects.
5. What are the effects of hormone use on the uterus?
Studies have shown that long-term exposure of the uterus to estrogen alone increases a woman's risk of endometrial cancer (cancer of the lining of the uterus). The risk of endometrial cancer for women taking estrogen plus progestin is nearly the same as for women not using estrogen. However, some studies have shown increases in endometrial cancer risk with estrogen plus progestin if progestins are used for less than 10 days per month.
Generally, among women who use menopausal hormones, women who have undergone hysterectomy (surgical removal of the uterus) have been given estrogen alone, whereas women who have not undergone this procedure have been given estrogen plus progestin.
6. What are the effects of menopausal hormones on heart disease?
The estrogen plus progestin component of the WHI compared two groups of women with no history of heart disease. The results showed that 5.2 years of estrogen plus progestin use was associated with a 29-percent increased risk of heart disease compared with women on placebo. The greatest increase in risk was found in the first year. On average, the researchers found that if a group of 10,000 women takes estrogen plus progestin for a year, 7 more cases of heart disease will occur than in 10,000 non-users.
Another randomized trial, the Heart and Estrogen/Progestin Replacement Study (HERS), concluded that estrogen combined with progestin has no beneficial effects on the heart in women with a history of heart disease. After 6.8 years of followup, there was no reduction in the risk of heart attacks or deaths from heart disease.
Some observational studies in which women reported whether they were using menopausal hormones have found evidence that estrogen alone may protect a woman against coronary heart disease (10). Most of the participants in these studies were healthy women at low risk for developing heart disease. The WHI is continuing to investigate the effects of estrogen alone on the heart in a randomized clinical trial that is expected to conclude in 2005.
7. What are the effects of menopausal hormones on bone health?
Osteoporosis is the loss of bone mass and density, which causes bones to become fragile and increases the chance of bone fractures. Low levels of estrogen have been linked to osteoporosis in women.
Estrogen alone and estrogen combined with progestin have been shown to protect against osteoporosis. Results from the WHI showed that estrogen plus progestin can prevent fractures of the hip, vertebrae, and other bones. On average, the researchers found that if a group of 10,000 women takes estrogen plus progestin for a year, 5 fewer cases of hip fractures will occur than in 10,000 non-users.
However, some studies have shown that the benefits on bone health disappear after short-term hormone use is discontinued. Use of estrogen for 3 to 5 years to relieve symptoms of menopause did very little to prevent fractures from osteoporosis in women when they reached ages 75 to 80. These studies suggested that women who take estrogen to maintain bone density must continue taking estrogen to benefit from its effects on bone health.
8. How does menopausal hormone use affect breast cancer risk and survival?
In 2002, the estrogen plus progestin component of the WHI concluded that combined estrogen and progestin increases the risk of invasive breast cancer. After an average of 5.2 years of followup, the study found a 26-percent increase in breast cancer risk among women taking the hormones as compared with women taking placebo. The increase amounted to an additional 8 cases of breast cancer for every 10,000 women treated for one year compared to 10,000 non-users.
After an average followup of 5.6 years, a more detailed analysis of the WHI results showed that, among women taking estrogen plus progestin, the breast cancers were slightly larger (1.7 versus 1.5 centimeters) and at more advanced stages compared with cancers in women taking the placebo. Among the women taking hormones, 25.4 percent of the cancers had spread outside the breast to nearby organs or lymph nodes compared with 16.0 percent among non-users.
Other studies also indicate an increase in breast cancer risk among hormone users. A 1997 analysis of over 90 percent of breast cancer studies throughout the world showed an increased risk of breast cancer for women who used menopausal hormones for 5 or more years. Most of the women included in these studies used estrogen alone; however, the women who used estrogen plus progestin appeared have a somewhat higher risk than those using estrogen alone (14). The increase in risk was seen not only in current users, but also in women who had stopped therapy some time in the previous 4 years. No increased risk was seen in women who had stopped therapy more than 4 years earlier.
Although observational studies indicate that both groups of hormone users have a higher risk of breast cancer than women who do not use menopausal hormones, the risk appears to be greater among women using estrogen plus progestin than in women using estrogen alone. One observational study found that risk increased with longer duration of hormone use and returned to normal 5 or more years after use was stopped.
The safety of menopausal estrogen use after breast cancer remains uncertain. One study of breast cancer patients showed that users of estrogen had lower mortality rates from breast cancer than patients who did not use estrogen. Most of these patients stopped using estrogen at the time of diagnosis. However, the benefit of past estrogen use diminished with time.
The component of the WHI study that includes 11,000 trial participants taking estrogen alone is expected to end in 2005, and will provide evidence on the effects of this hormone on breast cancer risk.
9. How does menopausal hormone use affect the risk of ovarian cancer?
observational study that followed 44,241 menopausal women for approximately 20 years concluded that estrogen use is associated with an increased risk of ovarian cancer. In this study, women who used estrogen alone for 10-19 years were twice as likely to develop ovarian cancer as women who did not use menopausal hormones. For women who used estrogen for 20 or more years, the risk of ovarian cancer increased to 3 times that of women who did not use menopausal hormones (18). Another recent large study also found an association between estrogen use and death due to ovarian cancer. In this study, the increased risk appeared to be limited to women who used estrogens for 10 or more years.
Because most studies have followed women using estrogen alone, there are currently not enough data to assess the potential effects of the estrogen-progestin combination on ovarian cancer risk. The study of 44,241 menopausal women mentioned above found that those who used estrogen plus progestin were not at increased risk of ovarian cancer, but the number of women in the study who had used the combination was small. Another study suggested that combined estrogen-progestin regimens do not increase the risk of ovarian cancer if progestin is used for more than 15 days per month. More research is needed to clarify the relationship between menopausal hormone use and the risk of ovarian cancer.
10. What are the effects of postmenopausal hormone use on quality of life and cognitive functions, specifically memory and learning?
Quality of life
Estrogen is prescribed to treat problems associated with menopause such as hot flashes, night sweats, and vaginal dryness. Menopausal hormones have also been thought to improve mood and psychological well-being in women who have hot flashes and sleeplessness during menopause.
However, a recent report from the WHI that focused on the quality of life of women ages 50 through 79 who took estrogen plus progestin indicated no significant effects on their general health, vitality, mental health, depressive symptoms, or sexual satisfaction. Although hormone use was associated with a small benefit in terms of sleep disturbance, physical functioning, and bodily pain after 1 year of use, the effect was too small to be considered clinically significant. At 3 years, there were no benefits in any quality of life issues.
The WHI results may not be relevant for women with severe menopausal symptoms, however. Participants in the WHI study were randomly assigned to receive either hormones or placebo, and those women who had menopausal symptoms reported relief from symptoms with hormone use. Women who felt that they needed menopausal hormones to treat severe symptoms may not have been willing to take the chance of not receiving hormones and may, therefore, have been underrepresented in the study.
A smaller study of women using estrogen plus progestin found that the effects on quality of life depended on whether or not a woman had menopausal symptoms. Among women experiencing hot flashes, estrogen plus progestin use improved mental health and depressive symptoms. Among those who did not experience hot flashes, however, no emotional benefits were associated with hormone use, and physical functioning (ranging from the ability to dress and bathe to the ability to participate in strenuous sports) was somewhat worse.
Memory and learning
Results from the WHI Memory Study showed that estrogen plus progestin doubled the risk for developing dementia (a decline in mental ability in which the patient can no longer function independently on a day-to-day basis) in postmenopausal women age 65 and older. The risk increased for all types of dementia, including Alzheimer's disease. A separate study also showed that estrogen plus progestin adversely affected cognitive function when women on the combination therapy were compared with women age 65 and older on placebo. Generally, the women in the WHI Memory Study age 65 and older did well on cognitive tests during the study, but the women on combination therapy did not do as well.
11. Are there other benefits or risks associated with menopausal hormone use?
Colon cancer
After 5 years of followup of women taking estrogen plus progestin, the WHI study reported a 37-percent reduction in colorectal cancer cases compared with women taking a placebo. On average, the researchers found that if a group of 10,000 women takes estrogen plus progestin for a year, 6 fewer cases of colon cancer will occur than in non-users.
The WHI trial of estrogen alone will provide information on whether estrogen has a similar effect.
Blood clots
Data from the WHI study showed that women who use estrogen plus progestin have double the combined rate of blood clots in the lungs and legs. On average, the researchers found that if a group of 10,000 women takes estrogen plus progestin for a year, 18 more cases of blood clots will occur than in non-users. Other studies have consistently reported increased risks of blood clots in the lung (pulmonary embolisms) and deep veins in the legs with hormone use.
Stroke
Data from the WHI study showed a 41-percent increase in the incidence of stroke for women using estrogen plus progestin compared with the women not using hormones. A longer followup for the same women reported a 31-percent increase in stroke, amounting to 7 additional cases of stroke for every 10,000 women for each year of treatment compared with 10,000 non-users. Previous observational studies have reported conflicting results regarding stroke risk, but two smaller randomized trials showed no significant effect on stroke for women taking either estrogen alone or estrogen plus progestin.
Gallbladder disease
Previous studies have consistently shown that women who use estrogen plus progestin are at increased risk for gallbladder disease.
12. What are the risks of menopausal hormones for women who have a history of cancer?
One of the roles of naturally occurring estrogen is to promote the growth of cells in the breast and uterus. For this reason, there is concern that menopausal estrogen use by women who have had cancer may promote further tumor growth. The safety of menopausal estrogen use after endometrial and breast cancer remains uncertain.
Little research has been done on the risks associated with menopausal hormone use by women who have had endometrial cancer. A few small studies have found no evidence that hormone use has a negative effect on survival and/or recurrence of the disease in these women. However, no large, long-term studies have compared the potential benefits, such as protection against osteoporosis, with the potential cancer risks.
One observational study of breast cancer patients, most of whom were using estrogen alone, reported no increase in recurrence or mortality among women who continued hormone use after their diagnosis. Another study of breast cancer patients showed that users of estrogen had lower mortality rates from breast cancer than patients who did not use estrogen. Most of these patients stopped using estrogen at the time of diagnosis. However, the benefit of prior estrogen use diminished with time.
13. Does the route of administration of hormones make a difference?
Most of the data on the long-term health effects of hormones come from studies where hormones (estrogen alone or estrogen in combination with progesterone or progestin) are administered orally in the form of pills. Other ways hormones are given include transdermal patches, gels, and vaginal creams and rings. These forms of estrogen are all equally effective methods of treating symptoms of menopause, such as hot flashes and vaginal dryness. In addition, progesterone is available as a pill or gel.
Several studies have found that the benefit of transdermal products on bone density and bone metabolism is comparable to that of oral therapy. It is not known whether transdermal estrogen and progestin will have different effects than pills on the heart and blood vessels.
The amount of estrogen that enters the bloodstream from estrogen-containing vaginal creams and rings depends on the types of hormones and the dose. Generally, vaginal administration of hormones results in lower levels of circulating hormones compared with an equivalent oral dose. Because the vaginal epithelium (thin layer of tissue that covers the vagina) responds to very small doses of estrogen, low-dose estrogen-containing creams can be used to correct some effects of menopause on the vagina. Vaginal estrogen therapy does not appear to protect against bone loss.
14. Are there any alternatives for women who choose not to take menopausal hormones?
Although menopausal hormones can have short-term benefits, several health concerns are associated with their use, and many women feel that hormones are not a good choice for them. Women should discuss with their health care provider whether to take menopausal hormones and what alternatives may be appropriate for them.
All women can adopt a healthy lifestyle by not smoking, exercising regularly, and eating a healthy diet. A healthy lifestyle helps to decrease a woman's risk of bone loss. Health professionals also recommend calcium and vitamin D supplements to prevent osteoporosis. Another part of the WHI, due to be finished in 2005, is testing the effect of calcium and vitamin D supplements on hip and other fractures as well as the effect on colon cancer. Other drugs, such as alendronate (Fosamax®), raloxifene (Evista®), and risedronate (Actonel®) have been shown to prevent bone loss, and are increasingly becoming the treatment of choice for osteoporosis in many menopausal women. Parathyroid hormone (Forteo®) has recently been approved by the Food and Drug Administration for osteoporosis treatment. Tibolone is being studied in clinical trials to prevent osteoporosis.
Although short-term menopause-related problems may go away on their own and frequently require no therapy at all, some women seek relief from these symptoms with nonprescription remedies, such as estrogen-containing foods (soy products, whole-grain cereal, seeds, and certain fruits and vegetables) and creams; herbs such as black cohosh; and vitamin E and vitamin B complexes. The benefits and risks of most of these agents are unproven, but remain an active area of research. Researchers are studying the safety and efficacy of these therapies. Local therapy is also available for vaginal dryness and urinary bladder conditions.
15. What research still needs to be done?
Questions remain about the adverse health effects associated with the use of estrogen alone in postmenopausal women. Additional unresolved issues are whether different forms of the hormones, lower doses, different hormones, or different routes of administration are safer or more effective; whether risks and/or benefits persist after women stop taking hormones; whether women might be able to take hormones safely for a short period of time; and whether certain subgroups of women might be at higher or lower risk than the general population.
The WHI continues to do research that focuses on ways to prevent heart disease, breast and colorectal cancer, and osteoporosis in menopausal women. Parts of the WHI will evaluate the effect of a diet low in fats and high in fruits, vegetables, and grains on the prevention of breast cancer, colorectal cancer, and heart disease, as well as the effect of calcium and vitamin D supplements on the prevention of osteoporosis-related fractures.
Several studies to evaluate the association between menopausal hormones and the occurrence of colorectal cancer are currently under way (40). Other research projects are described at various Government Web sites.
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