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Evista (Raloxifene Hydrochloride) - Summary

 
 



WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

  • Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA [see Warnings and Precautions ]. Women with active or past history of venous thromboembolism should not take EVISTA [see Contraindications].

  • 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 [see Warnings and Precautions and Clinical Studies].

 

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

Media Articles Related to Evista (Raloxifene)

Novel mode of action revealed for an osteoporosis drug
Source: Bones / Orthopedics News From Medical News Today [2014.09.03]
Raloxifene is a U.S. Food and Drug Administration (FDA)-approved treatment for decreasing fracture risk in osteoporosis.

more news >>

Published Studies Related to Evista (Raloxifene)

Raloxifene as an adjunctive treatment for postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial. [2011.11]
CONCLUSIONS: Raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia who exhibit prominent negative symptoms appears to be useful in improving negative, positive, and general psychopathological symptoms. If more extensive and longer-term studies confirm and expand upon these positive results, the use of raloxifene could be recommended in postmenopausal patients with schizophrenia. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01041092. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

Prospective, randomized comparison between raloxifene and clomiphene citrate for ovulation induction in polycystic ovary syndrome. [2011.09]
OBJECTIVE: To compare the ovulation rate between raloxifene and clomiphene citrate (CC) in patients with polycystic ovary syndrome (PCOS)...

Raloxifene and Tibolone in Elderly Women: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial. [2011.07.08]
OBJECTIVES: The authors' first aim was to study the effects of raloxifene and tibolone on body mass density, handgrip strength, and other secondary frailty components. The secondary aim was to compare the effects of raloxifene and tibolone and their safety in older women... CONCLUSION: In women >70 years old, raloxifene and tibolone significantly and similarly increased body mass density but not muscle strength. Raloxifene had also positive effects on verbal memory and health status. New research with selective estrogen receptor modulators like raloxifene might be promising on frailty endpoints in elderly women. TRIAL REGISTRATION NUMBER: Nederlands Trial Register: 1232. Copyright (c) 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.

[Effects of raloxifene on endothelial function and hemostasis in women with ischemic heart disease]. [2011.07]
INTRODUCTION AND OBJECTIVES: Modulation of vascular tone is one of the most relevant estrogen effects. A beneficial effect on endothelial function in postmenopausal women has also been proposed for the selective estrogen receptor modulator raloxifene. However, its effects in women with established cardiovascular disease have not been fully elucidated. In addition, recent trials have generated controversy regarding thromboembolic risk with raloxifene use. The aim of the study was to assess the effect of raloxifene on: a) endothelial function and b) coagulation and fibrinolysis pathways... CONCLUSIONS: The present study provides evidence that in postmenopausal women with demonstrated endothelial dysfunction and ischemic heart disease, mid-term treatment with raloxifene does not affect endothelial function. In the MERCED trial, no increased thrombotic risk was observed, but a decreased thrombotic and fibrinolytic activity was observed with raloxifene. Further studies are required to determine whether thrombotic risk is associated with specific clinical characteristics or subgroups of postmenopausal women with cardiovascular disease. Full English text available from: www.revespcardiol.org. Copyright (c) 2011 Sociedad Espanola de Cardiologia. Published by Elsevier Espana. All rights reserved.

Comparison of alendronate and raloxifene in postmenopausal women with osteoporosis. [2011.06]
OBJECTIVES: To compare the efficacy and tolerability of raloxifene (RLX) 60 mg daily and alendronate (ALN) 70 mg once weekly, either alone or in combination, on bone mineral density (BMD), bone turnover, and lipid metabolism in postmenopausal women with osteoporosis... CONCLUSIONS: Treatment of postmenopausal women with osteoporosis with RLX and ALN, alone and in combination, significantly increased the BMD of the lumbar spine, femoral neck and total hip and reduced markers of bone turnover. However, the effects of combined therapy were more pronounced than those of either monotherapy. On the other hand, RLX had some beneficial effects on lipid metabolism. Both medications, alone or in combination, had similar tolerability and safety profiles.

more studies >>

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.

Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women [Recruiting]
The efficacy of raloxifene versus placebo was compared over a six-month period, as an adjuvant treatment of the negative symptoms of schizophrenia in a group of 80 post-menopausal women. The aim of the study is to analyze whether raloxifene has an effect on the positive and negative symptoms of schizophrenia, and on psychopathological symptoms in general, and on social and neuropsychological functioning, and to study the influence of genetic polymorphisms in treatment response.

Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer [Recruiting]
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Selective estrogen receptor modulators, such as raloxifene, may work together with bicalutamide to stop the growth of prostate cancer.

PURPOSE: This clinical trial studies giving bicalutamide and raloxifene together in treating patients with metastatic or hormone-refractory prostate cancer.

Induction of Ovulation With Raloxifene or Clomiphene Citrate in Polycystic Ovarian Syndrome [Recruiting]
The Polycystic Ovarian Syndrome (PCOS) is a common disorder related to ovulation problems. Clomiphene citrate (CC) is the drug of first choice for this condition. Nevertheless, CC has a detrimental effect over uterine receptivity.

Raloxifene is a Selective Estrogen Receptor Modulator, that does not have a detrimental effect over the endometrium, and also increase the serum levels of FSH, thus, inducting ovulation.

The objective of this study is to compare the ovulation rate in PCOS patients between clomiphene citrate and raloxifene in a double blind randomized trial.

more trials >>

Reports of Suspected Evista (Raloxifene) Side Effects

Fall (43)HIP Fracture (26)Pain (22)Dizziness (22)Breast Cancer (21)Nausea (21)Drug Ineffective (20)Arthralgia (20)Vomiting (19)Femur Fracture (16)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 11 ratings/reviews, Evista has an overall score of 6.82. The effectiveness score is 6.55 and the side effect score is 7.45. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

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 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   osteopenia
Dosage & duration:   60 mg. taken once a day for the period of 2 weeks
Other conditions:   hypothyroidism
Other drugs taken:   levathyroxine, Lexapro, restasis
  
Reported Results
Benefits:   I didn't take the medicine long enough to get any benefits
Side effects:   I started having side effects within days of taking it but didn't realize it thinking that I was dealing with other health issues. I started out having a very bad sore throat, hoarse voice and cough. Went to a RediClini and got on antibiotic. Also went to see a Dr. 2 days later and was given a prednisone pack because I had chest congestion and by that time I had laryngitis plus shortness of breath. I dealt with these symptoms for 2 weeks. Cough and wheezing got better and then I realized the connection between getting all of these symptoms and the side effects. Checked online and sure enough, all of them were listed so I called the Dr. and stopped the medicine. Shortness of breath is better and my voice is getting somewhat better.
Comments:   None.

See all Evista reviews / ratings >>

Page last updated: 2014-09-03

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