The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women

Neven, Patrick; Silfen, Sheryl L.; Ciacci, Alberto; Akers, Robin; Bekele, Biniam M.; Eckert, Stephen

doi:10.1016/s0020-7292(00)84653-6

Cited by 4 publications

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“…Many clinical studies have now confirmed this action in the postmenopausal woman, in that endometrial thickness remains unchanged, biopsies of the endometrium show no signs of proliferative effects, and there is no evidence of uterine bleeding in subjects treated with raloxifene for up to 5 years 20. There is also no evidence of an increased risk of ovarian or endometrial cancer, in contrast to the results seen in some estrogen studies 21. In light of reported negative effects of various ER‐active drugs on pelvic floor integrity and urinary incontinence, an evaluation of the effect of raloxifene therapy on the frequency of surgery for pelvic floor relaxation has been completed recently, and it has been established that patients on the drug had the same rate of surgery as those on placebo 22…”

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confidence: 83%

“…20 There is also no evidence of an increased risk of ovarian or endometrial cancer, in contrast to the results seen in some estrogen studies. 21 In light of reported negative effects of various ER-active drugs on pelvic floor integrity and urinary incontinence, an evaluation of the effect of raloxifene therapy on the frequency of surgery for pelvic floor relaxation has been completed recently, and it has been established that patients on the drug had the same rate of surgery as those on placebo. 22 All of the early data on raloxifene are consistent with its being a mammary antiproliferative agent.…”

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confidence: 99%

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The Role of Selective Estrogen Receptor Modulators (SERMs) in Postmenopausal Health

Draper

2003

Annals of the New York Academy of Sciences

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Concerns about long-term therapy with HRT have recently highlighted interest in a class of compounds active in the estrogen receptor, but with selectivity in their actions, known as the selective estrogen receptor modulators (SERMs). Tamoxifen is recognized as the first widely marketed SERM, but its selectivity focuses interest on its approved indications: the treatment and prevention of breast cancer. Raloxifene has been approved in most countries of the world for the treatment and prevention of osteoporosis, and it displays a pattern of actions highly matched to the needs and concerns of many postmenopausal women. Further study of current and future SERMs promises to open new vistas in patient-specific management of the field of postmenopausal health.

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confidence: 83%

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confidence: 99%

The Role of Selective Estrogen Receptor Modulators (SERMs) in Postmenopausal Health

Draper

2003

Annals of the New York Academy of Sciences

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“…Serious adverse events included those that required in‐patient hospitalization, were life‐threatening or permanently disabling, were cancer, or resulted in death, and were required by the trial protocol to be reported immediately. Cardiovascular outcomes, cases of breast and endometrial cancer, and hip fracture were ascertained and evaluated as described in detail previously (5 , 8–11) . Cardiovascular events were collected by solicited questioning as well as by recording unsolicited reports of serious adverse cardiovascular events.…”

Section: Methodsmentioning

confidence: 99%

Risk-Benefit Profile for Raloxifene: 4-Year Data From the Multiple Outcomes of Raloxifene Evaluation (MORE) Randomized Trial

Barrett‐Connor¹,

Cauley²,

Kulkarni³

et al. 2004

Journal of Bone and Mineral Research

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Posthoc analysis of the MORE osteoporosis treatment trial assessed risk-benefit profile of raloxifene in 7705 postmenopausal women. A major disease outcomes global index resulted in annual rates of 1.39% and 1.83% in the raloxifene and placebo groups, respectively (HR, 0.75; 95% CI, 0.62-0.92), compatible with a favorable risk-benefit profile for raloxifene for treating postmenopausal osteoporosis.Introduction: The Women's Health Initiative (WHI) trial reported overall risks that exceeded benefits from use of estrogen-progestin in healthy postmenopausal women. The objective of this posthoc analysis of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial was to assess the safety profile of raloxifene, a selective estrogen receptor modulator indicated for the prevention and treatment of osteoporosis, using the global index method from the WHI trial. Materials and Methods: A total of 7705 postmenopausal women (mean age, 67 years) were enrolled in the MORE osteoporosis treatment trial and randomly assigned to receive placebo or one of two doses of raloxifene (60 or 120 mg/day) for 4 years. A global index of clinical outcomes, defined as described for the WHI trial (the earliest occurrence of coronary heart disease, stroke, pulmonary embolism, invasive breast cancer, endometrial cancer, colorectal cancer, hip fracture, or death because of other causes) was applied to the MORE trial data. Physicians blinded to treatment assignment adjudicated events. Intention-to-treat survival analysis of time-to-first-event was performed using a proportional hazards model. Results and Conclusions:The annualized rate of global index events was 1.83% in the placebo group and 1.39% in the combined raloxifene dose groups (hazard ratio [HR], 0.75; 95% CI, 0.62-0.92). Analyzing individual dose groups separately yielded the same results (HR for 60 mg/day, 0.75; 95% CI, 0.60 -0.96: HR for 120 mg/day, 0.75; 95% CI, 0.59 -0.95). Subgroup analyses showed no significant interactions between age or hysterectomy status and the effect of raloxifene on the global index (interaction p Ͼ 0.1), whereas the global index risk reduction seemed to be greater in obese women compared with nonobese women (interaction p ϭ 0.03). The significant 25% reduction in global index is compatible with a favorable risk-benefit safety profile when raloxifene is used for osteoporosis treatment in postmenopausal women. These results require confirmation in ongoing clinical trials.

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“…However, raloxifene was associated with a 50% reduction in the incidence of endometrial cancer (RR: 0.50; 95% CI: 0.29–0.85), compared with untreated controls, in a recent abstract describing a large case–control study [89]. The RR of ovarian cancer was 0.5 in nearly 10,000 patients in randomized, controlled trials with raloxifene, but with only 16 total cases, this difference is not statistically significant [90].…”

Section: Effects Of Raloxifene On the Uterusmentioning

confidence: 99%

Raloxifene: A Selective Estrogen-Receptor Modulator for Postmenopausal Osteoporosis – a Clinical Update on Efficacy and Safety

Deal

Draper

2006

Womens Health (Lond Engl)

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Selective estrogen-receptor modulators are molecules with specific estrogen-receptor binding affinity. Each selective estrogen-receptor modulator induces a unique conformation in the ligand-receptor complex, which leads to transcriptional activation and/or inhibition. Raloxifene 60 mg/day, a benzothiophene selective estrogen-receptor modulator, is approved for the prevention and treatment of postmenopausal osteoporosis. This article provides an update on new studies and further analyses of clinical trial data for raloxifene. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial of women with osteoporosis has described the efficacy of raloxifene in decreasing vertebral fracture risk over 4 years. The Continuing Outcomes Relevant to Evista((R)) (CORE) trial, designed to assess the effects of raloxifene on breast cancer prevention, is a 4-year continuation of MORE. The skeletal and cardiovascular effects of raloxifene in the CORE study were similar to those observed in MORE. The relative risk of developing breast cancer was significantly decreased in women treated with raloxifene, compared with placebo, after 4 years in MORE and 8 years in the CORE trial. The incidence of uterine bleeding, endometrial hyperplasia and endometrial cancer was similar between raloxifene and placebo after 8 years of treatment. Raloxifene use is associated with a higher incidence of hot flashes and leg cramps, and an increased risk of venous thromboembolic events.

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The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women

Cited by 4 publications

References 0 publications

The Role of Selective Estrogen Receptor Modulators (SERMs) in Postmenopausal Health

The Role of Selective Estrogen Receptor Modulators (SERMs) in Postmenopausal Health

Risk-Benefit Profile for Raloxifene: 4-Year Data From the Multiple Outcomes of Raloxifene Evaluation (MORE) Randomized Trial

Raloxifene: A Selective Estrogen-Receptor Modulator for Postmenopausal Osteoporosis – a Clinical Update on Efficacy and Safety

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