More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks.
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Mammographic density is a risk factor for breast cancer. Mammographic density and breast magnetic resonance imaging (MRI) volume (MRIV) assess the amount of fibroglandular tissue in the breast. Mammographic density and MRIV can be modulated with hormonal interventions, suggesting that these imaging modalities may be useful as surrogate endpoint biomarkers for breast cancer chemoprevention trials. We evaluated the effect of raloxifene on mammographic density and MRIV in premenopausal women at increased risk for breast cancer.
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Selective oestrogen receptor modulators (SERMs) are compounds that act as oestrogen agonists on selected targets while being oestrogen antagonists on others. The main targets of SERMs are oestrogen agonist activity on bone metabolism and several functions of the cardiovascular system, as well as oestrogen antagonism in the breast and uterus. They are indicated for the treatment and/or prevention of breast and endometrial cancer, osteoporosis and coronary heart disease. The extensive documentation of the multiple oestrogen effects on the CNS, greater understanding of the mechanisms of action, and especially the discovery of a second oestrogen receptor with differentiated distribution and mechanisms, have all led the way to the possibility of specific CNS-targeted SERMs. The demonstration that oestrogen selectively improves cognition, delays the appearance of Alzheimer's dementia, improves the feeling of well-being, as well as the response to antidepressant medications, provides targeted CNS indications for SERMs. The CNS effects of the currently marketed SERMs are not sufficiently explored yet. However, in postmenopausal women, tamoxifen and raloxifene probably show the most oestrogen agonist CNS effects. In women of reproductive age, competition with oestrogen probably exists, resulting in antagonist effects. Activity in men is still mostly unknown. It is quite safe to predict that the recent accumulation of knowledge, combined with the large, thirsty anticipated market for these 'designer oestrogens', will lead to clinical trials of CNS-targeted SERMs in the very near future.
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We report the case of perineal aggressive angiomyxoma in a 46-year-old woman presenting as left perineal swelling associated with superficial dyspareunia. Initial clinical examination revealed a 4- to 5-cm cystic mass in the posterior aspect of the left labia majora, not thought to be typical of a Bartholin cyst. A magnetic resonance imaging (MRI) scan revealed a well-defined 2- x 1.5- x 2-cm area posterolateral to the lower vagina on the left but anterolateral to the anal canal extending into the left ischiorectal fossa, with no obvious involvement of the anal sphincter complex. Excision biopsy was performed via an incision in the left labia majus under general anesthesia. Histologic findings were consistent with aggressive angiomyxoma of the vulva. This was confirmed by immunohistochemistry showing spindle cells positive for vimentin with strong nuclear staining for estrogen and progestogen receptors. Postoperative management following discussion at the multidisciplinary gynecological oncology meeting was to perform a repeat MRI scan 6 weeks postoperatively, and treatment with raloxifene was commenced for its antiestrogenic property.
We obtained samples of peripheral blood from 6 postmenopausal women with osteopenia at baseline and after 3 and 6 months of raloxifene therapy and 10 postmenopausal women who did not receive raloxifene therapy. Whole blood from raloxifene-treated women was stimulated with lipopolysaccharide (LPS) or phytohemeagglutinin (PHA). Whole blood from postmenopausal women who were not treated with raloxifene was preincubated with raloxifene at concentrations of 10(-10)-10(-7) M and then stimulated with LPS or PHA. Concentrations of IL-1β, IL-4, IL-6, IL-12p40, IL-12p70, TNF-α and IFN-γ in the supernatant were measured by respective ELISAs.
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Because PTH improves microarchitecture, macroarchitecture and mass of bone, it might produce better long-term protection against fracture, when given first and followed by antiresorptive therapy, compared with antiresorptive agents alone. Results of studies on combination therapy must distinguish previously untreated vs. previously treated individuals. PTH should be considered in women with persistent osteoporosis on established bisphosphonates or raloxifene, in which adding PTH might produce better results than switching to PTH. There are still many unanswered questions concerning PTH therapy, one of the most important being the optimal regimen.
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Drug transporters have been shown to alter drug metabolism. Similarly, bioactivation of drugs may also be altered by drug transporters. The aim of this work was to examine the role of P-glycoprotein (Pgp) in the bioactivation of a Pgp substrate, raloxifene, and a non-Pgp substrate, naphthalene. To evaluate the extent of bioactivation, covalent binding was measured. In both freshly isolated and cryopreserved hepatocytes, the extent of raloxifene covalent binding increased significantly (p < 0.05) in the presence of verapamil, whereas no change was observed with the covalent binding of naphthalene. To ascertain that the change was a Pgp effect, covalent binding was examined in microsomes in which raloxifene and naphthalene covalent binding was not altered in the presence of verapamil. In addition, the measure of raloxifene-glutathione adducts in the cryopreserved hepatocytes showed that the formation of the adducts increased in the presence of verapamil, which supports the idea that blocking Pgp in the liver increases metabolism and, therefore, the bioactivation of raloxifene. Because raloxifene and naphthalene are known to undergo bioactivation mediated by CYP3A4, covalent binding in the presence of ketoconazole was examined. In both hepatocytes and microsomes, raloxifene covalent binding decreased significantly (p < 0.01). It is interesting that naphthalene covalent binding was not affected. In the presence of the CYP2E inhibitor 4-methylpyrazole, a decrease in naphthalene covalent binding was observed, suggesting that the formation of the 1,2-epoxide may be the main culprit contributing to naphthalene covalent binding. In conclusion, these data suggest that in addition to other "protective" mechanisms, Pgp may attenuate bioactivation of drugs.
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Elevated insulin-like growth factor I (IGF-I) is associated with an increased risk for developing breast cancer in premenopausal women, whereas lower leptin levels have been documented in premenopausal breast cancer cases. We determined the effect of raloxifene on IGF-I, insulin-like growth factor binding protein 3 (IGFBP-3), and leptin in premenopausal women at high risk for developing invasive breast cancer. Twenty-eight premenopausal women (median age 43 years) participating in a pilot breast cancer prevention trial provided 56 matched serum samples. Specimens were collected at baseline and after treatment with 60 mg of raloxifene daily. Median treatment duration was 3 months (range: 6 weeks to 12 months). Samples were frozen at -70 degrees C until analysis. IGF-I, IGFBP-3, and leptin were measured by ELISA. Significance was evaluated by the Wilcoxon signed rank test. Raloxifene administration increased serum IGFBP-3 [mean change 245 ng/ml; P = 0.017; 95% confidence interval (CI), 76-415] and leptin (mean change 2.1 ng/ml; P = 0.005; 95% CI, 0.6-3.7). No significant change in serum IGF-I was detected (mean change 2.6 ng/ml; P = 0.84; 95% CI, -15.4 to 20.6). IGF-I:IGFBP-3 molar ratio was stable (mean change -0.014; P = 0.30; 95% CI, -0.041 to 0.012). Raloxifene administration is associated with an increase in IGFBP-3 and leptin in premenopausal high risk women. Increases in IGFBP-3 may potentially decrease the activity of circulating IGF-I. The effect of modulating the IGF pathway and leptin on breast cancer risk needs additional evaluation.
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After 1 year of raloxifene treatment, patients with iPTH levels of < 250 pg/ml in Group A showed significantly less BMD deterioration than similar patients in Group B (A: -0.31 +/- 1.7% vs. B: -3.71 +/- 0.7%, p = 0.04). However, raloxifene showed no difference in patients with iPTH levels of > or = 250 pg/ml in the two groups (A: -3.49 +/- 0.7% vs. B: -6.10 +/- 1.9%, p = 0.09). Among the patients with iPTH levels of < 250 pg/ml, changes in the ACI values were 1.30 +/- 0.3% for Group A and 1.67 +/- 1.0% for Group B. Among the patients with iPTH levels of (3) 250 pg/ml, the ACI values were 2.58 +/- 0.7% for Group A and 3.01 +/- 1.2% for Group B.
We aimed to analyze the effects of raloxifene and estrogen on thyroid gland morphology of ovariectomized rats. Raloxifene treatment led to effects similar to those of estrogen on thyroid glands from ovariectomized rats, so that both were able to normalize the changes detected after ovariectomy.
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Raloxifene, a selective estrogen receptor modulator, reduces osteoporosis and invasive breast cancer risk but increases risk for venous thromboembolism and fatal stroke in women with or at high risk for coronary heart disease. To assess the risk/benefit of raloxifene as a preventative treatment, we analyzed treatment effects on overall and cause-specific mortality.
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Of the 27 subjects who completed 12 months of raloxifene, 23 had paired prolactin samples, and 20 had paired estradiol and SHBG samples. Prolactin levels did not significantly change with raloxifene treatment, but SHBG levels increased (mean change = 7.3 nmol/L; P = 0.0001; 95% confidence interval, 3.9-10.7). Estradiol (mean change = 42 pg/mL; P = 0.048; 95% confidence interval, 1-84 pg/mL) levels were elevated when comparing 15 of the 20 women with paired estradiol measurements who also had both of these samples taken during the early follicular phase of the menstrual cycle.
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Prevalent vertebral fracture status (p < 0.0001), baseline lumbar spine BMD (p < 0.0001), and number of years postmenopausal (p = 0.0005) were independent predictors of fracture risk in raloxifene-treated patients. Therapy-by-change in femoral neck BMD (p = 0.02) and therapy-by-change in osteocalcin (OC; p = 0.01) were also significant for all treatment groups, indicating that changes in BMD and OC have different effects on fracture risk for the placebo and pooled raloxifene groups. The final model included significant baseline variables and change in OC (p = 0.01), whereas change in femoral neck BMD was not significant. After adjustment of each significant baseline variable, the percent change in OC was better able to predict the reduction in vertebral fracture risk than the percent change in femoral neck BMD in patients treated with raloxifene.
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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.
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Biochemical indices increased rapidly during PTH treatment with peak increments of 125-584% for the three markers (p<0.001 vs. baseline). After one year of PTH, mean BMD increases were 9.6% for spine, 2.7% for total hip, 3.6% for trochanter (all p<0.005) and 1.2% in femoral neck (NS), while BMD declined 4.3% in the radius (p=0.003). After PTH withdrawal, on continued raloxifene, BMD declined slightly (0.7-2.9% losses; NS) at all sites, except the femoral neck, where BMD increased modestly (p=0.04). At 24 months, spine and femoral neck BMD remained significantly higher than baseline, while radius BMD remained significantly lower (all p<0.04).
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The strontium ranelate (SR) group had significantly higher vertebral BMD than all other groups. Femoral density in the SR group was also significantly higher than in other groups and there was no difference between femoral density in the strontium ranelate and sham groups.
Cumulative evidence from epidemiological, preclinical and clinical studies suggests estrogens may have psychoprotective effects in schizophrenic patients. Selective Estrogen Receptor Modulators could have therapeutic benefits in schizophrenia for both sexes without being hazardous to gynecological tissues or having feminizing effects. Few studies have been conducted regarding the effects of raloxifene on postmenopausal women suffering from schizophrenia. We conducted this placebo-controlled trial to compare the add-on effect of raloxifene to risperidone versus risperidone with placebo.
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The primary aim of this study was to examine time trends in prevalence and incidence of AOD use the first year after a forearm fracture from 2005-2012. Further, secondary aims were to investigate if gender, the number of drugs used before fracture, or use of glucocorticoids influenced the prescription of AOD, and to examine adherence to AOD.
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Raloxifene hydrochloride, a selective estrogen receptor modulator, prevents bone loss in postmenopausal women, but whether it reduces fracture risk in these women is not known.
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Raloxifene is a selective estrogen receptor modulator (SERM) that prevents bone loss. Although it is largely used for the treatment of osteoporosis, the mechanisms by which this compound modulates the activity of bone cells are still poorly understood. In this study we investigate whether raloxifene affects osteoclast and osteoblast activity in vitro. Bone marrow cultures were established from neonatal mice and treated with 1,25(OH)(2) vitamin D(3) (VitD(3), 10(-8) mol/L) to induce osteoclast generation. Similar to 17beta-estradiol, raloxifene significantly reduced the number of osteoclasts in a concentration-dependent manner, with maximal inhibition at 10(-11) mol/L (-48%). However, as for 17beta-estradiol, at a high concentration (10(-7) mol/L), the inhibitory effect of raloxifene was abolished. In a pit assay, raloxifene inhibited bone resorption. A maximal effect was observed at 10(-9) mol/L, and maintained at a high concentration, indicating that inhibition of osteoclast formation and inhibition of bone resorption may be due to activation of, at least in part, different pathways. Osteoblasts from neonatal mice calvariae were also exposed to raloxifene. In these cells, this compound induced a concentration-dependent increase of proliferation, which was blocked by the estrogen-receptor antagonist ICI 164,384. Raloxifene also increased the osteoblast-specific transcription factor Cbfa1/Runx2 and alpha2 procollagen type I chain mRNAs, with a pattern that only partially coincided with that of 17beta-estradiol. Consistent with decreased osteoclastogenesis, raloxifene inhibited the mRNA expression of interleukin (IL)-1beta and IL-6 at a low concentration, but not at a high concentration, whereas 17beta-estradiol had similar effects on IL-6 and inhibited IL-1beta at both concentrations. Furthermore, both compounds were able to inhibit tumor necrosis factor (TNF)-alpha-induced IL-1beta, but not IL-6, increase. In conclusion, these data show that raloxifene negatively modulates osteoclasts, and positively affects osteoblasts, suggesting not only an antiresorptive role, but also an osteoblast stimulatory role.
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Tamoxifen, and even more raloxifene, were effective in reducing HCT8 and HCT116 cell proliferation and viability, suggesting their potential application in the prevention and therapy of colorectal cancer.