Evista (Raloxifene Hydrochloride) - Summary

EVISTA SUMMARY

These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.
EVISTA (raloxifene hydrochloride) Tablet for Oral use
Initial U.S. Approval: 1997

EVISTA® (raloxifene hydrochloride) is a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:

EVISTA is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

For either osteoporosis treatment or prevention, supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.

Postmenopausal osteoporosis may be diagnosed by history or radiographic documentation of osteoporotic fracture, bone mineral densitometry, or physical signs of vertebral crush fractures (e.g., height loss, dorsal kyphosis).

No single clinical finding or test result can quantify risk of postmenopausal osteoporosis with certainty. However, clinical assessment can help to identify women at increased risk. Widely accepted risk factors include Caucasian or Asian descent, slender body build, early estrogen deficiency, smoking, alcohol consumption, low calcium diet, sedentary lifestyle, and family history of osteoporosis. Evidence of increased bone turnover from serum and urine markers and low bone mass (e.g., at least 1 standard deviation below the mean for healthy, young adult women) as determined by densitometric techniques are also predictive. The greater the number of clinical risk factors, the greater the probability of developing postmenopausal osteoporosis.

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NEWS HIGHLIGHTS

Published Studies Related to Evista (Raloxifene)

Low-dose transdermal estradiol induces breast density and heterogeneity changes comparable to those of raloxifene. [2009.07]
The aim of this study was to investigate whether transdermal low-dose estradiol treatment induces changes in mammographic density or heterogeneity compared with raloxifene, whether if these changes relate to changes in bone formation/resorption markers, and whether these findings indicate elevation of breast cancer risk by treatment...

Teriparatide and raloxifene reduce the risk of new adjacent vertebral fractures in postmenopausal women with osteoporosis. Results from two randomized controlled trials. [2009.06]
BACKGROUND: Vertebral fractures increase the risk of new vertebral fractures; however, we are not aware of any study addressing the risk of new vertebral fractures adjacent to existing vertebral fractures. Therefore, we sought to determine the influence of the number and severity of prevalent (preexisting) vertebral fractures on the risk of new adjacent vertebral fractures and to determine whether teriparatide (rhPTH [recombinant human parathyroid hormone] [1-34]) or raloxifene treatment reduces the incidence of adjacent vertebral fractures in postmenopausal women with osteoporosis... CONCLUSIONS: In untreated postmenopausal women with osteoporosis, nearly half of the incident vertebral fractures occur adjacent to an existing vertebral fracture. Both teriparatide and raloxifene can significantly reduce the occurrence of new adjacent and nonadjacent vertebral fractures.

Raloxifene reduces circulating levels of interleukin-7 and monocyte chemoattractant protein-1 in postmenopausal women. [2009.06]
OBJECTIVE: The aim of the present study was to determine the effects of raloxifene on changes in circulating levels of cytokines and chemokines in relation to changes in lipid profiles and markers of inflammation in postmenopausal women... CONCLUSION: Circulating levels of IL-7 and MCP-1 decrease in postmenopausal women who received raloxifene.

Effect of microdose transdermal 17beta-estradiol compared with raloxifene in the prevention of bone loss in healthy postmenopausal women: a 2-year, randomized, double-blind trial. [2009.05]
OBJECTIVE: Declining estrogen levels after menopause result in bone loss and increased fracture risk. This study investigated whether transdermal microdose 17beta-estradiol (E2) has efficacy and safety comparable to those of raloxifene, a selective estrogen-receptor modulator approved for the prevention and treatment of postmenopausal osteoporosis... CONCLUSIONS: Transdermal microdose E2 was similarly effective as raloxifene in preventing bone loss at the lumbar spine. Both treatments were well tolerated, with no clinically significant effect on endometrium or breast density.

Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors. [2009.02.24]
CONCLUSIONS: In postmenopausal women at increased risk of coronary events, the overall lack of benefit of raloxifene was similar across the prespecified subgroups.

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Clinical Trials Related to Evista (Raloxifene)

Comparison of Raloxifene Hydrochloride and Placebo in the Treatment of Postmenopausal Women With Osteoporosis [Completed]
To study the effect of long-term treatment with raloxifene, compared with placebo, on the rate of new vertebral fractures in osteoporotic postmenopausal women with and without existing vertebral fractures.

Long Term Effects of Raloxifene Treatment on Bone Quality [Completed]
This is a cross-sectional study to determine, via iliac crest bone biopsies, the effect of long-term treatment with raloxifene on histomorphometry and bone quality in patients who participated in the Continuing Outcomes Relevant to Evista Study.

Cognition in the Study of Tamoxifen and Raloxifene [Completed]
The purpose of this study is to assess the effects of tamoxifen and raloxifene on cognitive aging in selected cognitively-healthy women.

The Safety and Effectiveness of Surgery With or Without Raloxifene for the Treatment of Pelvic Pain Caused by Endometriosis [Completed]
Many women with lower abdominal pain have endometriosis. Endometriosis is a condition in which the lining of the uterus (endometrium) is found outside of the uterus. The diagnosis of endometriosis is usually made at surgery. The treatment of endometriosis includes medical and surgical approaches alone or in combination. The hormone estrogen stimulates the growth of the endometrium and may also stimulate the growth of endometriosis. Medical therapies that act to decrease the level of estrogen can reduce the amount of endometriosis and pain. When therapies are discontinued, symptoms often return. In addition, medical treatment for endometriosis is expensive and is often associated with weak bones (osteoporosis) and hot flashes as a result of low levels of estrogen.

Surgical treatment is removal or destruction of the endometriosis tissue. Studies show the pain from endometriosis is relieved longer with tissue removal than with destruction.

This study was developed to see if surgery followed by daily doses of Raloxifene (Evista) is effective in reducing pain, for a longer time than surgery in combination with a placebo (inactive "sugar pill") treatment. Raloxifene acts like estrogens in some tissues and not like estrogens in others. Postmenopausal women receiving Raloxifene for the prevention of osteoporosis had an increase in bone density and an improvement of their blood lipids (fat content in the blood). However, unlike estrogen, Raloxifene does not promote the growth of breast tissue or the uterus. If Raloxifene blocks estrogen action in the lining of the uterus (endometrium) of reproductive age women, as it does in post-menopausal women, it may also limit the growth of endometriosis and prevent the return of pain.

Combined Estrogen Blockade of the Breast With Exemestane and Raloxifene in Postmenopausal Women With a History of Breast Cancer Who Have No Clinical Evidence of Disease [Active, not recruiting]
The purpose of this research study is to learn about the effects of two drugs when they are given together. The names of the drugs are raloxifene and exemestane.

Raloxifene is a drug that is related to estrogen. In the liver and bone, it acts like estrogen. In the breast and uterus it acts like an anti-estrogen. It has been used in postmenopausal women to prevent a disease called osteoporosis. This is a disease that decreases bone strength over many years and may finally lead to bone fractures. In a group of women who were taking the drug, it also seemed to decrease the chances of breast cancer and possibly endometrial cancer (cancer of the uterus). Therefore, we want to study it further to see if it prevents breast cancer. We also want to find out if it may be even better in preventing breast cancer if it is given with another drug.

The other drug in this trial is exemestane. Exemestane is a type of drug that works to decrease estrogen levels in postmenopausal women. This type of drug is used in women for the treatment of breast cancer. Before we can decide if the two drugs combined are better for preventing breast cancer, we must first test these drugs together to make sure that they are safe. This safety testing is the purpose of this trial.

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PATIENT REVIEWS / RATINGS / COMMENTS

Evista review by 64 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		high blood levels of thrombisin
Dosage & duration:		60mg taken 1 per day for the period of 3 years and still taking
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		normal thrombosin level within 6 weeks
Side effects:		none
Comments:		1 pill every morning

Evista review by 60 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		No Side Effects
		Treatment Info
Condition / reason:		LOSS OF BONE DENSITY
Dosage & duration:		20MG taken everyday for the period of 5 YEARS
Other conditions:		NONE
Other drugs taken:		NONE
		Reported Results
Benefits:		BONE DENSITY INCREASED. I HAD A BONE SCAN AND SHOWED ON THE BORDER LINE OF OSTEOPEROSIS, (?) WELL AFTER TAKING THIS DRUG, MY BONE MEASUREMENTS INCREASED. NO SIDE EFFECTS AND DEFIENTELY A GOOD MEDICATION FOR US BABY BOOMERS
Side effects:		NONE I DID NOT HAVE ANY SIDE EFFECTS, ONLY THAT MAYBE IT WILL HELP TO PREVENT BREAST CANCER, I HAVE A STRONG FAMILY HISTORY, MOTHER, GRANDMOTHER, AUNTS, COUSINS, WHO HAVE DIED OF BREAST CANCER. SO THIS MEDICATION IS A GOOD THING FOR ME.
Comments:		TOOK ONE TABLET A DAY, ALSO FOUND OUT IT HELPS TO PREVENT BREAST CANCER. I HAVE BEEN TAKING FOR OVER 5 YEARS NOW, I NEVER HAD A SIDE EFFECT, TAKE EVERYNIGHT WITH MY MEAL. NO ADVERSE EFFECTS. I WILL CONTINUE TO TAKE FOR THE REST OF MY LIFE.

Evista review by 68 year old female patient
		Rating
Overall rating:
Effectiveness:		Moderately Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		loss of bone density
Dosage & duration:		60 mg taken once daily for the period of nine years (continuing to take)
Other conditions:		moderately high hypertension, underactive thyroid
Other drugs taken:		Benazepril/HCTZ and Synthroid
		Reported Results
Benefits:		Since beginning treatment with Evista, I have had three DEXA scans, and my bone density has remained stable. I have had no broken bones or spinal fractures during this period, and I have heighth has remained the same.
Side effects:		I have had infrequent, but painful, leg cramps in my thighs.
Comments:		I take one 60mg pill daily which can be taken anytime of the day, with or without food.