Is evista a hormone?

Evista

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to EVISTA in 8429 patients who were enrolled in placebocontrolled trials, including 6666 exposed for 1 year and 5685 for at least 3 years.

Osteoporosis Treatment Clinical Trial (MORE)

The safety of raloxifene in the treatment of osteoporosis was assessed in a large (7705 patients) multinational, placebo-controlled trial. Duration of treatment was 36 months, and 5129 postmenopausal women were exposed to raloxifene hydrochloride (2557 received 60 mg/day, and 2572 received 120 mg/day). The incidence of all-cause mortality was similar among groups: 23 (0.9%) placebo, 13 (0.5%) EVISTA-treated (raloxifene HCl 60 mg), and 28 (1.1%) raloxifene HCl 120 mg women died. Therapy was discontinued due to an adverse reaction in 10.9% of EVISTA-treated women and 8.8% of placebo-treated women.

Venous Thromboembolism: The most serious adverse reaction related to EVISTA was VTE (deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis). During an average of study-drug exposure of 2.6 years, VTE occurred in about 1 out of 100 patients treated with EVISTA. Twenty-six EVISTA-treated women had a VTE compared to 11 placebo-treated women, the hazard ratio was 2.4 (95% confidence interval, 1.2, 4.5), and the highest VTE risk was during the initial months of treatment.

Common adverse reactions considered to be related to EVISTA therapy were hot flashes and leg cramps. Hot flashes occurred in about one in 10 patients on EVISTA and were most commonly reported during the first 6 months of treatment and were not different from placebo thereafter. Leg cramps occurred in about one in 14 patients on EVISTA.

Placebo-Controlled Osteoporosis Prevention Clinical Trials

The safety of raloxifene has been assessed primarily in 12 Phase 2 and Phase 3 studies with placebo, estrogen, and estrogen-progestin therapy control groups. The duration of treatment ranged from 2 to 30 months, and 2036 women were exposed to raloxifene HCl (371 patients received 10 to 50 mg/day, 828 received 60 mg/day, and 837 received from 120 to 600 mg/day).

Therapy was discontinued due to an adverse reaction in 11.4% of 581 EVISTA-treated women and 12.2% of 584 placebo-treated women. Discontinuation rates due to hot flashes did not differ significantly between EVISTA and placebo groups (1.7% and 2.2%, respectively).

Common adverse reactions considered to be drug-related were hot flashes and leg cramps. Hot flashes occurred in about one in four patients on EVISTA versus about one in six on placebo. The first occurrence of hot flashes was most commonly reported during the first 6 months of treatment.

Table 1 lists adverse reactions occurring in either the osteoporosis treatment or in five prevention placebo-controlled clinical trials at a frequency ≥ 2.0% in either group and in more EVISTA-treated women than in placebo-treated women. Adverse reactions are shown without attribution of causality. The majority of adverse reactions occurring during the studies were mild and generally did not require discontinuation of therapy.

Table 1: Adverse Reactions Occurring in Placebo-Controlled Osteoporosis Clinical Trials at a Frequency ≥ 2.0% and in More EVISTA-Treated (60 mg Once Daily) Women than Placebo- Treated Womena

Comparison Of EVISTA And Hormone Therapy

EVISTA was compared with estrogen-progestin therapy in three clinical trials for prevention of osteoporosis. Table 2 shows adverse reactions occurring more frequently in one treatment group and at an incidence ≥ 2.0% in any group. Adverse reactions are shown without attribution of causality.

Table 2: Adverse Reactions Reported in the Clinical Trials for Osteoporosis Prevention with EVISTA (60 mg Once Daily) and Continuous Combined or Cyclic Estrogen Plus Progestin (Hormone Therapy) at an Incidence ≥ 2.0% in any Treatment Groupa

EVISTA
(N=317) %
Hormone Therapy-Continuous Combinedb
(N=96) %
Hormone Therapy-Cyclicc
(N=219) %
Urogenital
Breast Pain 4.4 37.5 29.7
Vaginal Bleedingd 6.2 64.2 88.5
Digestive
Flatulence 1.6 12.5 6.4
Cardiovascular
Hot Flashes 28.7 3.1 5.9
Body as a Whole
Infection 11.0 0 6.8
Abdominal Pain 6.6 10.4 18.7
Chest Pain 2.8 0 0.5
aThese data are from both blinded and open-label studies.
bContinuous Combined Hormone Therapy = 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate.
cCyclic Hormone Therapy = 0.625 mg conjugated estrogens for 28 days with concomitant 5 mg medroxyprogesterone acetate or 0.15 mg norgestrel on Days 1 through 14 or 17 through 28.
dIncludes only patients with an intact uterus: EVISTA, n=290; Hormone Therapy-Continuous Combined, n=67; Hormone Therapy-Cyclic, n=217.

Breast Pain

Across all placebo-controlled trials, EVISTA was indistinguishable from placebo with regard to frequency and severity of breast pain and tenderness. EVISTA was associated with less breast pain and tenderness than reported by women receiving estrogens with or without added progestin.

Gynecologic Cancers

EVISTA-treated and placebo-treated groups had similar incidences of endometrial cancer and ovarian cancer.

Placebo-Controlled Trial Of Postmenopausal Women At Increased Risk For Major Coronary Events (RUTH)

The safety of EVISTA (60 mg once daily) was assessed in a placebo-controlled multinational trial of 10,101 postmenopausal women (age range 55-92) with documented coronary heart disease (CHD) or multiple CHD risk factors. Median study drug exposure was 5.1 years for both treatment groups . Therapy was discontinued due to an adverse reaction in 25% of 5044 EVISTA-treated women and 24% of 5057 placebo-treated women. The incidence per year of all-cause mortality was similar between the raloxifene (2.07%) and placebo (2.25%) groups.

Tamoxifen-Controlled Trial Of Postmenopausal Women At Increased Risk For Invasive Breast Cancer (STAR)

The safety of EVISTA 60 mg/day versus tamoxifen 20 mg/day over 5 years was assessed in 19,747 postmenopausal women (age range 35-83 years) in a randomized, double-blind trial. As of 31 December 2005, the median follow-up was 4.3 years. The safety profile of raloxifene was similar to that in the placebo-controlled raloxifene trials .

Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions reported very rarely since market introduction include retinal vein occlusion, stroke, and death associated with venous thromboembolism (VTE).

Read the entire FDA prescribing information for Evista (Raloxifene)

Raloxifene Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 5, 2018.

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In Summary

Commonly reported side effects of raloxifene include: infection, flu-like symptoms, hot flash, and sinusitis. Other side effects include: lower limb cramp. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to raloxifene: oral tablet

Warning

Oral route (Tablet)

Increased risk of deep vein thrombosis and pulmonary embolism have been reported. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride. Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke.

Along with its needed effects, raloxifene may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking raloxifene and get emergency help immediately if any of the following effects occur:

Rare

  • Coughing blood
  • headache or migraine headache
  • loss of or change in speech, coordination, or vision
  • pain or numbness in chest, arm, or leg
  • shortness of breath (unexplained)

Check with your doctor as soon as possible if any of the following side effects occur while taking raloxifene:

More common

  • Bloody or cloudy urine
  • chest pain
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • infection, including body aches or pain, congestion in throat, cough, dryness or soreness of throat, runny nose, and loss of voice
  • leg cramping
  • skin rash
  • swelling of hands, ankles, or feet
  • vaginal itching

Less common

  • Abdominal pain (severe)
  • aching body pains
  • congestion in lungs
  • decreased vision or other changes in vision
  • diarrhea
  • difficulty in breathing
  • hoarseness
  • loss of appetite
  • nausea
  • trouble in swallowing
  • weakness

Some side effects of raloxifene may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Hot flashes, including sudden sweating and feelings of warmth (especially common during the first 6 months of treatment)
  • increased white vaginal discharge
  • joint or muscle pain
  • mental depression
  • problems of stomach or intestines, including passing of gas, upset stomach, or vomiting
  • swollen joints
  • trouble in sleeping
  • weight gain (unexplained)

For Healthcare Professionals

Applies to raloxifene: oral tablet

Cardiovascular

Very common (10% or more): Hot flashes/hot flushes/vasodilation (28.7%), increased blood pressure

Common (1% to 10%): Varicose vein, venous thromboembolism (VTE)

Postmarketing reports: Death related to VTE

Other

Very common (10% or more): Flu syndrome (16.2%), infection (15.1%), peripheral edema (14.1%)

Common (1% to 10%): Chest pain, fever

Musculoskeletal

Very common (10% or more): Arthralgia (15.5%), muscle spasms/leg cramps (12.1%)

Common (1% to 10%): Myalgia, arthritis, tendon disorder

Respiratory

Very common (10% or more): Sinusitis (10.3%), rhinitis (10.2%)

Common (1% to 10%): Bronchitis, pharyngitis, increased cough, pneumonia, laryngitis

Dermatologic

Common (1% to 10%): Rash, sweating

Endocrine

Common (1% to 10%): Breast pain/tenderness/enlargement

Gastrointestinal

Genitourinary

Hepatic

Common (1% to 10%): Cholelithiasis, cholecystectomy

Frequency not reported: Slightly decreased platelet counts, moderate increases in AST and/or ALT

Metabolic

Common (1% to 10%): Weight gain

Nervous system

Common (1% to 10%): Headache/migraine, syncope, vertigo, neuralgia, hypesthesia, stroke, death related to stroke

Ocular

Common (1% to 10%): Conjunctivitis

Postmarketing reports: Retinal vein occlusion

Psychiatric

Common (1% to 10%): Depression, insomnia

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia

Oncologic

Uncommon (0.1% to 1%): Benign endometrial polyps

Frequency not reported: Endometrial cancer, ovarian cancer, endometrial atrophy

1. “Product Information. Raloxifene (raloxifene).” Prasco Laboratories, Cincinnati, OH.

2. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

3. Cerner Multum, Inc. “Australian Product Information.” O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

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  • Prevention of Osteoporosis

Raloxifene is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is in a class of drugs called estrogen agonists/antagonists that have been developed to provide the beneficial effects of estrogens without all of the potential disadvantages. It is neither an estrogen nor a hormone. Raloxifene is sometimes called a selective estrogen receptor modulator (SERM).

Raloxifene reduces the risk of spine fractures. There are no data showing that raloxifene reduces the risk of hip and other non-spine fractures. For both prevention and treatment, raloxifene is taken daily as a 60 mg tablet, with or without meals.

Raloxifene appears to decrease the risk of estrogen-dependent breast cancer by 65 percent over eight years. It is FDA-approved to decrease the risk of invasive breast cancer in postmenopausal women with osteoporosis and even in women without osteoporosis who are at high risk of breast cancer. Raloxifene does not reduce the risk of coronary heart disease.

Side Effects

Side effects include hot flashes, leg cramps and an increased risk of deep vein thrombosis (blood clots). Other side effects include swelling and temporary flu-like symptoms. Raloxifene is not associated with diseases of the uterus or ovaries and does not affect cognitive (mental) function.

Raloxifene should not be taken by women at increased risk for stroke. This includes women who have had previous strokes, transient ischemic attacks (TIAs), atrial fibrillation (a type of serious irregular heart beat) or uncontrolled hypertension (high blood pressure).

Is Raloxifene the Answer to the HRT Story?

The search for the most optimal post-menopausal hormone replacement therapy (HRT) is rapidly becoming one of the most widely pursued ventures in modern medicine. A few basic goals should be considered. The optimal agent should prevent cardiovascular disease; it should prevent osteoporosis and encourage osteoblastic proliferation; it should not have an adverse effect on target tissue; and last, but not least, it should be effective in relieving the patient’s symptoms.

A typical scenario is a woman who makes an office visit because she is experiencing perimenopausal symptoms such as vasomotor events or sleep dysfunction. She may already be knowledgeable about HRT and have formed strong opinions about whether she would be interested in receiving this therapy. Added to the dilemma is the fact that many women perceive HRT as “unnatural.”1 Women may pursue health food supplements as an alternative to traditionally prescribed therapies, because these supplements are perceived as natural and thereby free of adverse effects. These women may already have purchased some of these products before visiting the family physician’s office.

How do family physicians address this issue? First of all, how convinced are we that traditional HRT does what it is purported to do without adverse effects? Second, how convinced are we that nontraditional therapies are of unproved benefit or harmful to the patient? Third, have we done a careful review of the woman’s risk of breast cancer, cardiovascular disease and osteoporosis?

The bottom line is that what really matters more than risk is the patient’s perception of benefit or harm. Even if the woman has numerous risk factors that may affect her long-term health and longevity, she is not going to take HRT unless she believes it will do her no harm. Therein lies the dilemma. The fear of breast cancer, whether overestimated or not, is causing many women to decline HRT. Discussions that center on the fact that more women die of cardiovascular disease than breast cancer may not convince the patient that she only has a low risk of developing breast cancer while receiving HRT. Therefore, before a discussion of the pros and cons of HRT is initiated, the woman’s fears and concerns have to be addressed rationally and compassionately. Because the patient may desire only relief of undesired symptoms, she may not view the entire portfolio of preventive health options that HRT affords.

The article by Scott and associates2 reviews the unique properties of the selective estrogen receptor modulators (SERMs) that mimic the beneficial effects of estrogen on the cardiovascular and skeletal system while minimizing adverse effects on other tissue such as breast. SERMs are synthetic compounds that bind with high affinity to estrogen receptors and act as either estrogen agonists or antagonists. They are called “designer” drugs, because they are designed to target certain tissue receptors and avoid others.

The epithelium of the breast is stimulated by estrogen. Whether this stimulation induces abnormal epithelial growth is a subject of debate. A direct cause-and-effect relationship between estrogen and development of breast cancer has not been established. Tamoxifen (Nolvadex), classified as an estrogen antagonist on breast tissue, has been approved for the treatment of early and advanced breast cancer and for the prevention of breast cancer. Studies have demonstrated significant reductions in breast cancer recurrence and mortality in survivors who used adjuvant tamoxifen therapy.3 The downside of tamoxifen therapy is that it acts as a partial estrogen agonist in endometrial tissue, thus only partially blocking the stimulatory effect of estrogen on the endometrium.

Another SERM, raloxifene (Evista), is designed to mimic the effect of estrogen on the skeletal structure and serum lipids but, unlike tamoxifen, acts as a complete estrogen antagonist in the breast and endometrium. To date, there is no convincing evidence that raloxifene stimulates endometrial tissue or increases the risk of endometrial cancer.4 The Multiples Outcomes of Raloxifene Evaluation study5 compared the use of raloxifene with placebo in postmenopausal patients with documented osteoporosis. Compared with placebo, risk of vertebral fracture was reduced in two groups of women receiving different dosages of raloxifene. The reduction was seen both in women with prevalent fracture and in women without prevalent fracture. Risk of nonvertebral fractures did not differ significantly when raloxifene was compared with placebo. Raloxifene increased bone mineral density in the femoral neck and spine. The beneficial effects of raloxifene in reducing fracture incidence were in addition to the beneficial effects of supplemental calcium and cholecalciferol. However, clinical recommendations from these data must consider that, until more definitive comparisons are completed, estrogen or bisphosphonates remain the preferred therapy for postmenopausal women at high risk for nonspinal fractures.6

Does this all mean that raloxifene is the most optimal postmenopausal replacement drug? Although it is a synthetic compound and is somewhat less effective than estrogen as a preventive agent, will women more readily accept it if the breast cancer issue is resolved? The crucial question is still unanswered and will not be answered until the results of the National Cancer Institute’s Study of Tamoxifen and Raloxifene (STAR) are known. It is impossible to make direct comparisons between the two SERMs at this point.

The controversial data on the link between breast cancer and HRT are primarily derived from reexamination of observational studies that suggest that a slightly increased risk of breast cancer has often but not always been seen with increasing duration of HRT use by postmenopausal women.7 The uneasiness about the postulated link between HRT and breast cancer is still unresolved, and the current data on raloxifene do not allow clinical recommendations to be made at this time. The search for the “perfect” postmenopausal replacement drug continues.

Characteristics of Patients Initiating Raloxifene Compared to Those Initiating Bisphosphonates

Abstract and Background

Abstract

Background: Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis.
Methods: This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan®). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate.
Results: Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model.
Conclusion: In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.

Background

Osteoporosis is the most common bone disease in the United States, affecting approximately 10 million people over the age of 50. An additional 18 million individuals have osteopenia, a precursor of osteoporosis. Osteoporosis contributes to more than 1.5 million fractures each year and is the primary underlying cause of fractures in the elderly.

Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis. Raloxifene increases vertebral BMD and reduces the risk of vertebral fractures in postmenopausal women with and without preexisting vertebral fractures but has not been shown to reduce the risk of nonvertebral fractures in patients versus placebo. However, studies of the efficacy of raloxifene in reducing the incidence of nonvertebral fractures were not adequately powered to determine whether this agent might also reduce the incidence of less frequent nonvertebral fractures. Bisphosphonates reduce the risk of vertebral fractures, and two of the aminobisphosphonates (i.e., alendronate and risedronate) have been shown to reduce the risk of nonvertebral fractures.

The relative efficacy of raloxifene and bisphosphonates must be considered alongside the safety profiles associated with each treatment. The most common adverse events associated with raloxifene are hot flushes and leg cramps. In addition, raloxifene has been associated with a two-fold increase in venous thromboembolism. Data from clinical trials suggest that raloxifene reduces the risk of invasive breast cancer in postmenopausal women and in 2007, raloxifene received approval from the FDA for reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer. The Raloxifene Use for the Heart (RUTH) trial, which was conducted with women at high risk of coronary events, indicated that there was no difference in overall mortality, cardiovascular mortality, or overall number of strokes versus placebo, however there was an increased risk of fatal stroke. Thus, the risk benefit profile of raloxifene should be considered in women at risk for stroke. The most common adverse events associated with bisphosphonates are GI-related and include esophageal ulceration, stricture, and bleeding. Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection has been reported in patients taking bisphosphonates. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but some have occurred in patients with postmenopausal osteoporosis.

Given the differing efficacy and safety profiles exhibited by raloxifene and the bisphosphonates, it is plausible that physicians would target these agents in such a way as to optimize the corresponding benefit/risk profile for individual patients. To explore this hypothesis, we sought to describe and compare the demographic and clinical characteristics of patients who initiate raloxifene therapy relative to patients initiating treatment with bisphosphonates.

Imaginis

Treating Osteoporosis

Preventing osteoporosis by maintaining a health diet rich in calcium and vitamin D and exercising regularly can help many women avoid the serious effects of osteoporosis. Women who have low bone mineral density or osteoporosis may also benefit from taking hormone replacement therapy or other drug therapies. This section describes treatments for osteoporosis.

Hormone Replacement Therapy

Hormone replacement therapy (HRT) is synthetic estrogen and/or progesterone (called progestin). Past research has shown that that has been shown to be effective in treating osteoporosis. However, recent research has found that HRT may not provide these benefits and may pose other risks, including an increased risk of ovarian cancer (with long-term use) and cancer of the uterine lining (in women do not take progestin with estrogen).

HRT is designed to “replace” a woman’s depleting hormone levels at menopause. HRT is commonly prescribed to help relieve menopausal symptoms, such as hot flashes and vaginal dryness. HRT is thought to be most effective against osteoporosis if taken during the first five years after menopause begins.

Because of the risks associated with HRT, women should talk with their physicians about whether HRT is an appropriate treatment option for osteoporosis, and may wish to consider alternative treatments.

Bisphosphonates – Fosamax (alendronate) and Actonel (risedronate sodium)

The drugs, Fosamax (generic name, alendronate) and Actonel (generic name, risedronate sodium), belongs to a group of drugs called bisphosphonates. They are commonly used to prevent and treat osteoporosis in post-menopausal women. Fosamax and Actonel are not estrogens and do not carry the associated risks or benefits of estrogen (see the hormone replacement therapy section above).

Studies show that after three years of use, Fosamax can reduce the risk of hip fractures in patients with a history of vertebral fracture by 51%. Actonel can reverse bone loss and help reduce the risk of bone fractures by halting further loss of bone and increasing bone mass. Actonel is not an estrogen and does not carry the associated risks or benefits of estrogen Recent research shows that Fosamax may be combined with hormone replacement therapy (HRT), and in fact, when used in combination, patients may receive increased protection from fractures. However, HRT does carry some risks (see the hormone replacement therapy section above). Also, the long-term use of combination Fosamax and HRT has not been assessed.

Fosamax and Actonel should be taken first thing in the morning in an upright position (sitting or standing) with six to eight ounces of plain water. Patients should not eat or drink anything besides plain water with the medicines, and they should not lie down within 30 minutes of taking the medicines. Calcium, vitamin D, or other supplements should be taken at a separate time.

Side effects of bisphosponates include:

  • Abdominal or musculoskeletal pain
  • Nausea
  • Heartburn
  • Irritation of the esophagus

More information on Fosamax, courtesy of Merck and Company, Inc.

More information on Actonel, courtesy Proctor and Gamble.

Evista (raloxifene)

Evista (generic name, raloxifene) belongs to a group of drugs called SERMs (selective estrogen-receptor modulators) and is prescribed to help prevent and treat osteoporosis. Evista helps build new bone and reduces the risk of fractures. In several studies, Evista has reduced the risk of bone fractures by 50%. Most post-menopausal women who take Evista are prescribed one pill a day (60 milligrams). Physicians recommend that women take calcium and vitamin D supplements in addition to Evista to further reduce the risk of fractures.

As with every drug, Evista has a range of possible side effects, both positive and negative. One positive effect of Evista is that is has been shown to reduce LDL (“bad”) cholesterol and total cholesterol levels, which can decrease a woman’s risk of heart disease. Studies are also investigating whether Evista may also help prevent breast cancer in women at high risk for the disease.

As with every drug, Evista has a range of possible side effects, both positive and negative. One positive effect of Evista is that is has been shown to reduce LDL (“bad”) cholesterol and total cholesterol levels, which can decrease a woman’s risk of heart disease.

Common side effects of Evista may include:

  • hot flashes
  • leg cramps
  • swelling of the legs and feet
  • flu-like symptoms
  • joint pain
  • sweating

Evista can also increase the risk of deep vein thrombosis (blood clots in the deep veins of the leg) and pulmonary embolism (blood clots in the lungs). Women who have a history of blood clots should not take Evista.

More information on Evista, courtesy of Eli Lilly and Company.

Fosamax (alendronate)

Fosamax (generic name, alendronate) belongs to a group of drugs called bisphosphonates and is commonly used to prevent and treat osteoporosis in post-menopausal women. Fosamax has been shown to strengthen bones and reduce hip and spinal fractures. Studies show that after three years of use, Fosamax can reduce the risk of hip fractures in patients with a history of vertebral fracture by 51%. Recent research shows that Fosamax may be combined with hormone replacement therapy (HRT), and in fact, when used in combination, patients may receive increased protection from fractures. However, the long-term use of combination Fosamax and HRT has not been assessed.

Side effects of Fosamax may include:

  • Abdominal pain
  • Nausea
  • Indigestion
  • Constipation and diarrhea
  • Muscle or joint pain
  • Headache

In addition, some patients who take Fosamax develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus. These reactions can cause chest pain, heartburn or difficulty or pain upon swallowing. The risk of severe esophageal adverse reactions appears to be greater in patients who lie down immediately after taking Fosamax and/or those who fail to take Fosamax with a full glass of water. Patients should not take Fosamax if they have certain disorders of the esophagus, they cannot stand or sit upright for at least 30 minutes, they have low levels of calcium in their blood, or they have severe kidney disease. Fosamax is available in once daily or once weekly regimens.

More information on Fosamax, courtesy of Merck and Company, Inc.

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Evista (chemical name: raloxifene) is a SERM approved by the U.S. Food and Drug Administration (FDA) to:

  • reduce the risk of hormone-receptor-positive breast cancer in postmenopausal women who haven’t been diagnosed but are at higher-than-average risk for disease
  • reduce the risk of hormone-receptor-positive breast cancer in postmenopausal women being treated for osteoporosis who haven’t been diagnosed with breast cancer
  • treat and prevent osteoporosis in postmenopausal women

Evista isn’t used to treat breast cancer after it’s been diagnosed. Evista also won’t work on hormone-receptor-negative breast cancer.

Evista is a pill that is taken once per day, with or without food. Most doctors recommend taking Evista at the same time every day.

You should not take Evista if you are breastfeeding, pregnant, trying to get pregnant, or if there is any chance that you could be pregnant. Evista may cause damage to developing embryos. You should use an effective non-hormonal type of birth control — such as condoms, a diaphragm along with spermicide, or a non-hormonal I.U.D. – while you are taking Evista. Ask your doctor which type of non-hormonal birth control would be best for you, as well as how long you should use this type of birth control after you stop taking Evista.

Benefits of Evista

The large STAR (Study of Tamoxifen and Raloxifene) trial compared Evista and tamoxifen, another SERM, to see if one medicine was better than the other at reducing the risk of invasive breast cancer in postmenopausal women. The researchers also looked at whether postmenopausal women who took Evista or tamoxifen had similar quality of life.

STAR trial results showed that Evista and tamoxifen offer the same reduction in risk — both medicines lower the risk of invasive breast cancer by about 50%. Both medicines also offer the same overall quality of life.

Like tamoxifen, Evista also can strengthen the bones of postmenopausal women and reduce the risk of osteoporosis. Evista has been shown to reduce the risk of spinal fractures due to osteoporosis.

Unlike tamoxifen, Evista isn’t affected by the CYP2D6 enzyme. The body uses the CYP2D6 enzyme to convert tamoxifen into its active form. Two things can interfere with the body’s ability to make this happen: a flaw in the CYP2D6 enzyme and certain medications that block the effectiveness of this enzyme. So Evista may be a good risk-reduction option for postmenopausal women at higher-than-average risk for breast cancer who have an abnormal version of the CYP2D6 enzyme or are taking another medicine that blocks CYP2D6 activity.

Side effects of Evista

Evista’s selective estrogen activation effects can cause some serious side effects, including blood clots and stroke. If you and your doctor are considering Evista as part of your treatment plan, tell your doctor if you smoke or have a history of blood clots or heart attack. If you’re taking Evista, call your doctor immediately if you have any of these symptoms:

  • leg pain or warmth in the calves
  • swelling of the legs, hands, or feet
  • chest pain
  • shortness of breath
  • vision problems
  • weakness
  • difficulty speaking or understanding
  • sudden severe headache

The most common side effects of Evista are:

  • hot flashes
  • leg cramps
  • swelling
  • flu-like symptoms
  • sleeping problems
  • joint/bone pain
  • sweating
  • dry skin

Some women on Evista have reported memory problems while taking the medicine. While no definitive results are available yet, the ongoing Co-STAR (Cognition in the Study of Tamoxifen and Raloxifene) trial is looking at the effects Evista and tamoxifen have on memory and thinking.

How long do I take Evista?

Since Evista is a relatively new medicine (it was approved by the FDA in 2007 to reduce the risk of hormone-receptor-positive breast cancer in postmenopausal women who had never been diagnosed with disease), it’s not clear yet how long you should take Evista to get the most risk reduction benefits. In the STAR trial, women took Evista for 5 years. Depending on your unique situation, your doctor may recommend that you take Evista for a longer or shorter amount of time.

Does insurance cover Evista?

Costs for Evista can vary. If you have health insurance, check with your insurance company to see if and how much of the cost of Evista is covered. If you don’t have health insurance or your insurance doesn’t cover the cost of Evista, ask your doctor or nurse about programs in your area that may be able to help.

Eli Lilly and Company, the company that makes Evista, sometimes offers vouchers for Evista on the medicine’s website.

You can also read the Breastcancer.org Paying for Your Care section for information on additional types of financial assistance and cost-lowering tips.

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Last modified on June 8, 2015 at 12:52 PM

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CURExtra – Evista Gives Women Another Choice for Preventing Breast Cancer

For the past two generations, a member of Evelyn Smith DeMille’s family has died of breast cancer at a young age-her aunt at 41, then her younger sister at 38. “I have a daughter who will be 21 in August,” DeMille says. “There is a good chance we have a genetic predisposition.”

DeMille originally signed up for the Breast Cancer Prevention Trial (BCPT) in the early 1990s. After the BCPT was completed, she signed up for the STAR (Study of Tamoxifen and Raloxifene) chemoprevention trial rather than taking the five-year course of tamoxifen that was offered to her. “I see this study as a step along the way to prevent breast cancer for all women,” DeMille says.

Effectiveness Without the Toxicity

The STAR trial, one of the largest breast cancer prevention trials ever conducted, enrolled nearly 20,000 postmenopausal women with a high risk of breast cancer, including DeMille. Participants received either daily Evista® (raloxifene) or tamoxifen for five years. The trial, conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) and sponsored by the National Cancer Institute, showed that Evista works as well as tamoxifen in lowering the risk of breast cancer in this high-risk population. Although participants in the STAR trial were required to have at least 1.67 percent risk of developing a breast cancer in the next five years which is considered high risk-the average was closer to 4 percent.

While both drugs appear to reduce the risk of developing invasive breast cancer by half, fewer side effects were associated with Evista than with tamoxifen, making it a better choice for some women. Data show that the group on Evista had 36 percent fewer uterine cancers and 29 percent fewer blood clots. Although both drugs increase the risk of blood clots, only tamoxifen is associated with uterine cancers, especially of the endometrium (lining of the uterus). Tamoxifen also increases the risk of cataracts, a long-term side effect not associated with Evista.

“Findings of raloxifene being equally effective with fewer side effects provide women with another option,” says Worta McCaskill-Stevens, MD, STAR’s program director. “It allows them to have a choice of an agent that has fewer blood clots, endometrial cancers and cataracts.”

While both drugs prevented invasive breast cancers, tamoxifen also protects against non-invasive breast cancers—ductal carcinoma in situ (DCIS) and lobular carcinoma in situ (LCIS)—whereas Evista does not. In situ cancers, though not usually classified as cancer, are confined in the milk ducts and do not reach the fatty or connective tissue of the breast.”These non-invasive entities can be picked up by screening mammograms,” says Dr. McCaskill-Stevens. “They are not life-threatening diseases.” But while most in situ cancers are DCIS, LCIS comprises 10 percent of cases and is considered a high risk factor for invasive cancer. (Watch for the Fall issue of CURE, which will feature non-invasive breast cancer.)

Whether or not the positive data with Evista will encourage more high-risk women to take chemopreventive agents is still unanswered. Although long-term tamoxifen trials prove the drug reduces risk by half, women may choose not to take the drug for prevention. A 2004 study by Beth Israel Deaconess Medical Center in Boston found that many women, even those at high risk for the disease, feel the side effects and risks outweigh the possible benefit. STAR researchers hope the trial results will initiate conversation between patients and primary care physicians about chemoprevention and give them another choice in addition to tamoxifen.

“I think we have a lot of education to do on breast cancer risk and agents available,” Dr. McCaskill-Stevens says.

Doing Double Duty

Like tamoxifen, Evista is a selective estrogen receptor modulator (SERM), which helps prevent estrogen from binding to cancer cells and inhibits cancer cell growth. As a SERM, Evista also stops the thinning of bone tissue and increases the amount of good tissue, thus lowering the risk of bone fracture. Approved for treating and preventing osteoporosis in postmenopausal women in 1997, Evista is currently prescribed to nearly half a million postmenopausal women for bone health.

Doctors hope that because of the dual benefit and fewer side effects, more high-risk women will use Evista. Currently, tamoxifen is the only FDA-approved drug for the prevention of breast cancer, but Eli Lilly and Company, the maker of Evista, intends to file the drug for approval for the reduction of invasive breast cancer risk in postmenopausal women by the end of the year. STAR researchers have also been in talks with FDA officials about the study’s implications.

For Some, Tamoxifen Still the Best Choice

D. Lawrence Wickerham, MD, associate chairman of the NSABP and the study’s protocol officer, expects women will be using Evista to lower their breast cancer risk in the near future, but an in-depth conversation between patient and doctor on the risks and benefits is essential, he says, because Evista is not for everyone.

Dr. Wickerham says that since tamoxifen and Evista are chemically similar, women who have already had five years of tamoxifen would not be good candidates for Evista. Tamoxifen provides the maximum benefit for breast cancer prevention at five years, so following tamoxifen with Evista would increase the risk of side effects without any additional benefit. Women who have taken tamoxifen and are looking for agents to improve bone health should find alternatives, such as Fosamax® (alendronate) or Actonel® (risedronate).

Because Evista has not been tested in premenopausal women, tamoxifen is still the only choice for this group. The same holds true for breast cancer survivors.

Experts say some women probably shouldn’t be on either drug, including those with a high risk of blood clots, stroke, uncontrolled high blood pressure or uncontrolled diabetes.

While DeMille has completed five years of Evista, she’s continuing with her annual mammograms, the STAR trial’s follow-up tests and hopes to participate in new prevention clinical trials. “I try to do as much as I can to volunteer for research studies, to push the envelope and help find the answers.”

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Final results from the STAR trial will be presented at the American Society for Clinical Oncology annual meeting next month.

For more information on the STAR trial, go to http://www.nsabp.pitt.edu/STAR/Index.asp.

To calculate breast cancer risk, visit www.breastcancerprevention.com and www.cancer.gov/bcrisktool.

Editor’s note: On September 14, 2007, the FDA approved Evista (raloxifene) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis and in postmenopausal women at high risk for invasive breast cancer.

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