0
selected
-
1.
Retinal structural changes in patients receiving tamoxifen therapy by spectral-domain optical coherence tomography.
Bolukbasi, S, Kandemir Gursel, O, Cakir, A, Erden, B, Karatas, G
Cutaneous and ocular toxicology. 2020;(2):115-121
Abstract
Purpose: To evaluate choroidal thickness, ganglion cell complex (GCC) and photoreceptor outer segment (PROS) length were measured in patients with breast cancer undergoing tamoxifen therapy, using spectral-domain optical coherence tomography (SD-OCT); results were compared with those for normal eyes.Materials and methods: Forty-four patients with breast cancer, undergoing tamoxifen therapy, and 41 healthy controls were included in this prospective, comparative study. All participants underwent a complete ophthalmologic evaluation and SD-OCT. Subfoveal, nasal (nasal distance to fovea 500, 1000, 1500 μm), and temporal (temporal distance to fovea 500, 1000, 1500 μm) choroidal thickness measurements were performed using the enhanced depth imaging mode of SD-OCT. Using an Early Treatment Diagnostic Retinopathy Study (ETDRS) circle at the macular level, the automated retinal segmentation software was applied to determine the thickness of the GCC. PROS length was determined manually, as the distance from the inner surface of the ellipsoid zone to the inner surface of retina pigment epithelium.Results: The mean choroidal thickness was statistically greater in the tamoxifen group than controls in all quadrants (p < 0.001 for all quadrants). Of all tamoxifen users (44 eyes of 44 patients), 33 eyes (75%) had uncomplicated pachychoroid (UCP). Pachychoroid pigment epitheliopathy (PPE) was detected in five tamoxifen-group patients (11.3%). Patients with PPE in one eye had UCP in the fellow eye. Central serous chorioretinopathy findings were observed in one patient. Tamoxifen users had statistically lower GCC thickness in all inner rings of the ETDRS inlay and in the nasal outer ring only (p = 0.027, 0.002, 0.002, 0.001, and 0.030, respectively). No statistically significant difference in mean subfoveal PROS length was found between the groups.Conclusions: SD-OCT provides valuable information for identifying structural changes and evaluating ocular findings in patients receiving tamoxifen therapy. Increased choroidal thickness, PPE and thinning GCC were detected in tamoxifen users. These OCT findings may be an early indicator of retinal toxicity for patients undergoing tamoxifen therapy in the follow-up period.
-
2.
Influence of the selective oestrogen receptor modulator (raloxifene hydrochloride) on IL-6, TNF-alpha, TGF-beta1 and bone turnover markers in the treatment of postmenopausal osteoporosis.
Ozmen, B, Kirmaz, C, Aydin, K, Kafesciler, SO, Guclu, F, Hekimsoy, Z
European cytokine network. 2007;(3):148-53
Abstract
BACKGROUND Osteoporosis that is encountered frequently in postmenopausal women, may cause an increased incidence of vertebral and iliac fractures that are associated with excess morbidity. Raloxifene hydrochloride, a selective oestrogen receptor modulator, has been shown to increase bone mineral density and decrease biochemical markers of bone turnover in postmenopausal women, without stimulatory effects on breast or uterus. Levels of proinflammatory cytokines, including IL-6, and TNF-alpha and TGF-beta1 which are important cytokines involved in remodeling, have been evaluated previously in in vitro studies of osteoporosis. However, there seems to be a paucity of in vivo research concerned with changes in these cytokines in osteoporosis. OBJECTIVE In this study, we evaluated the effects of raloxifene (Evista); Lilly Pharmaceutical Co. USA, 60 mg/day) on biochemical bone turnover markers, serum parathyroid hormone, and 25-OH vitamin D, as well as the serum levels of IL-6, TNF-alpha and TGF-beta1, in 22 postmenopausal, osteoporotic women before and after 12 weeks of raloxifene treatment. METHODS Well-matched, postmenopausal, non-osteoporotic control subjects were also enrolled in the study. Serum levels of all the parameters were measured in postmenopausal, osteoporotic women at baseline and end of the study. RESULTS It was found that serum osteocalcin and parathyroid hormone, and urine deoxypyridinoline levels decreased to normal levels with treatment. Serum 25-OH vitamin D levels after treatment in the patient group were higher than those in the control group. Serum IL-6, TNF-alpha and TGF-beta1 levels did not change significantly with treatment. However, serum levels of IL-6 and TGF-beta1 in the patient group after treatment, decreased to levels lower than those found in the control group. Serum TNF-alpha levels in the patient group before and after treatment, were lower than those in the control group. CONCLUSION Raloxifene treatment reduces bone turnover biochemical markers, parathyroid hormone and induces 25-OH vitamin D in postmenopausal women. Moreover, it also affects some serum cytokine levels in the postmenopausal period.
-
3.
Effects of raloxifene on changes in bone density.
Miskić, B, Bistrović, D, Vizner, B, Cosić, V, Miskić, D, Herman, D
Collegium antropologicum. 2006;(4):767-70
Abstract
Raloxifene hydrochloride therapy effectiveness in bone mineral density (BMD) changes compared to calcium and vitamin D3 therapy over a 2-year period. Case-control study: a group of 254 women was prescribed raloxifene (raloxifene hydrochloride) together with calcium and vitamin D3 while other group of 254 women used calcium and vitamin D3 therapy. BMD was measured at the hip, spine and forearm at the beginning and at the end of the 2-year period. Treatment with raloxifene resulted in a 3.7% increase in BMD at the spine in 98% of examinees. A 1.2% BMD increase was shown in 75% of examinees at the hip. A 1.2% decrease in BMD at forearm shown in 93% of examinees using raloxifene. The calcium and vitamin D3 therapy led to an increase in BMD in 58% examinees at the spine, in 56% at the hip and in 38% at the forearm, which was significantly lower than in women using raloxifene. Among women using calcium and vitamin D alone an average BMD decrease of 1.2% was registered on 42% of examinees at the spine, 2.6% decrease on 46% of examinees at the hip and 4.2% decrease on 35% of examinees at the forearm. Treatment with raloxifene resulted in a significant increase in BMD at the spine with odds ratio (OR 5.85, p <0.05) compared with calcium and vitamin D3 alone. There was no statistically proven increase in BMD at either the hip (OR 0.015) or forearm (OR 0.122).
-
4.
Crossover trial for lipid abnormality in postmenopausal breast cancer patients during selective estrogen receptor modulators (SERMs) administrations.
Kusama, M, Kaise, H, Nakayama, S, Ota, D, Misaka, T, Aoki, T
Breast cancer research and treatment. 2004;(1):9-16
Abstract
The objective of this study was to evaluate the different profiles of serum lipids resulting from the administration of selective estrogen receptor modulators (SERMs). Postmenopausal primary breast cancer patients (n = 197) with node-negative, hormone receptor-positive who were treated at our department or in other related medical institutions from April 1997 through March 2001 were given adjuvant therapy. The adjuvant therapy included 1 year's administration of tamoxifen (TAM) 20 mg or toremifene (TOR) 40 mg. The profiles of serum lipids such as total cholesterol (TC), high-density lipoprotein cholesterol (HDL) and triglyceride (TG) were observed. After 1 year administration TC had significantly decreased (p < 0.001) both in the TAM group and the TOR group, but no significant difference was found between these groups (p = 0.249). HDL had significantly decreased in the TAM group (p < 0.001), while it had significantly increased in the TOR group (p < 0.001), and a significant difference was found between the groups (p < 0.001). TG had significantly increased in the TAM group (p < 0.001) but significantly decreased in the TOR group (p < 0.001). The medication was switched in those who still had abnormal lipid metabolism and given to them for another year. After 1 year from the crossover TC and HDL had increased to the levels of before administration (p < 0.001) and TG had decreased in those (n = 57) whose medication was switched from TAM to TOR. While TC had decreased and TG had increased in those (n = 23) whose medication was switched from TOR to TAM (p < 0.001). The above findings have suggested that TOR provides better profiles of lipid metabolism than TAM.
-
5.
Monitoring osteoporosis therapy with bone densitometry: misleading changes and regression to the mean. Fracture Intervention Trial Research Group.
Cummings, SR, Palermo, L, Browner, W, Marcus, R, Wallace, R, Pearson, J, Blackwell, T, Eckert, S, Black, D
JAMA. 2000;(10):1318-21
Abstract
CONTEXT The principle of "regression to the mean" predicts that patients with unusual responses to treatment might represent outliers who are likely to have more typical responses if treatment is continued without change. OBJECTIVE To test whether women who lose bone mineral density (BMD) during the first year of treatment for osteoporosis continue to lose BMD if the same treatment is continued beyond 1 year. DESIGN AND SETTING Two randomized, double-blind, placebo-controlled trials in 11 US clinical research centers for the Fracture Intervention Trial and 180 centers in the United States and other countries for the Multiple Outcomes of Raloxifene Evaluation Trial. PARTICIPANTS AND INTERVENTIONS Postmenopausal women with low BMD assigned to treatment with 5 mg/d of alendronate sodium in the Fracture intervention Trial who completed 2 years of BMD monitoring and adhered to study medication (n = 2634), and postmenopausal women with osteoporosis assigned to treatment with 60 or 120 mg/d of raloxifene hydrochloride in the Multiple Outcomes of Raloxifene Evaluation trial who similarly completed 2 years of monitoring while adhering to study medication (n = 3954). MAIN OUTCOME MEASURES Baseline, 12-, and 24-month hip and spine BMD. RESULTS Women with the greatest loss of BMD during the first year of treatment were the most likely to gain BMD during continued treatment. Specifically, among women taking alendronate whose hip BMD decreased by more than 4% during the first year, 83% (95% confidence interval [CI], 82%-84%)had increases in hip BMD during the second year, with an overall mean increase of 4.7%. In contrast, those who seemed to gain at least 8% during the first year lost an average of 1% (95% CI, 0.1%-1.9%) during the next year. Similar results were observed among women taking raloxifene for 2 years. CONCLUSIONS Our data suggest that most women who lose BMD during the first year of treatment with alendronate or raloxifene will gain BMD if the same treatment is continued for a second year. These results illustrate the principle of regression to the mean and suggest that effective treatments for osteoporosis should not be changed because of loss of BMD during the first year of use.