Adverse events reported by postmenopausal women in controlled trials with raloxifene

Davies, Graham C.; Huster, William J.; Lü, Yifei; Plouffe, Leo; Lakshmanan, Mark

doi:10.1016/s0029-7844(98)00476-1

Cited by 148 publications

(68 citation statements)

References 20 publications

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“…There was no difference between stroke and myocardial infarction between the two groups. Other large trials revealed similar results [13,16,22,26,28,29]. Consistent across these trials are the increases in hot flashes, night sweats, leg cramps and venous thromboembolic events (VTEs) with raloxifene compared to placebo.…”

Section: Safety Profilementioning

confidence: 66%

SERMs and SERMs with estrogen for postmenopausal osteoporosis

Bolognese

2010

Rev Endocr Metab Disord

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Bone loss with aging places postmenopausal women at a higher risk for osteoporosis and its consequences such as fractures, pain, disability, and increased morbidity and mortality. Approximately 200 million patients worldwide are affected. The Third National Health and Nutrition Examination Survey (NHANES III) estimated that up to 18% of US women aged 50 and older have osteoporosis and up to 50% have osteopenia. Greater than 2 million osteoporotic related fractures occurred in the United States with direct healthcare costs exceeding $17 billion. Hormone Replacement Therapy (HRT) was a popular option for postmenopausal women before the Women's Health Initiative (WHI). Several agents are available in the U.S., including bisphosphonates, hormone therapy, calcitonin, parathyroid hormone and the selective estrogen receptor modulator (SERM) raloxifene. There are concerns about long term safety and compliance. Therefore, other agents are under investigation. SERMs are a diverse group of agents that bind to the estrogen receptor and each SERM appears to have a unique set of clinical responses, which are not always consistent with the typical responses seen with other SERMs. This article will discuss the SERMs approved in the United States, tamoxifene and raloxifene, and investigational SERMs. The ideal SERM would include the beneficial effects of estrogen in bone, heart and the central nervous system, with neutral or antagonistic effects in tissues where estrogen effects are undesirable(breast and endometrium). A new target in treating postmenopausal osteoporosis is the tissue estrogen complex or the pairing of a SERM with a conjugated estrogen known as a tissue selective estrogen complex (TSEC). This novel approach is currently being evaluated with bazodoxifene which could yield the beneficial effects of estrogens and SERMS, while potentially being more tolerable and safer than either therapy alone.

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Section: Safety Profilementioning

confidence: 66%

SERMs and SERMs with estrogen for postmenopausal osteoporosis

Bolognese

2010

Rev Endocr Metab Disord

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“…Because raloxifene is a SERM, it could theoretically block the effects of local Es on the vaginal mucosa. However, raloxifene was shown not to cause any adverse vaginal symptoms (4) in patients who do not have vaginal atrophy. Moreover, it has been demonstrated that women with evidence of preexisting vaginal atrophy who are treated with either low-dose conjugated E cream or nonhormonal moisturizer were not negatively influenced with concurrent raloxifene treatment for osteoporosis (5).…”

mentioning

confidence: 85%

The effect of raloxifene in association with vitamin D on vaginal maturation index and urogenital symptoms in postmenopausal osteoporotic women

Zeyneloglu

Öktem

Haberal

et al. 2007

Fertility and Sterility

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“…In the Raloxifene Use for the Heart trial [72], raloxifene treatment demonstrated no difference in incidence of stroke but a 49% higher incidence of fatality due to stroke relative to placebo (59 vs 39 events, respectively; absolute risk increase of 0.7 per 1,000 woman-years). Raloxifene is also associated with an increased incidence of leg cramps and hot flushes [67,68,74].…”

Section: Raloxifenementioning

confidence: 99%

What is the best balance of benefits and risks among anti-resorptive therapies for postmenopausal osteoporosis?

Miller

Derman

2010

Osteoporos Int

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Pharmacologic osteoporosis therapy, particularly anti-resorptives, is recommended in postmenopausal women with clinical risk factors for fracture. Treatment decisions should be made based on the relative benefit-risk profile in different patient populations. Emerging options [e.g., selective estrogen receptor modulators (SERMs) and denosumab] may hold promise for providing protection from bone loss and for fracture risk reduction.Osteoporosis, the most common clinical disorder of bone metabolism, is characterized by low bone mineral density, deterioration of microarchitecture, and a consequent increase in bone fragility and risk of fracture. Pharmacologic therapy is recommended in postmenopausal women with clinical risk factors for fracture and includes anti-resorptive agents such as bisphosphonates, hormone therapy, SERMs, and calcitonin. The anabolic agent teriparatide (parathyroid hormone) is usually reserved for high-risk patients or those with glucocorticoid-induced osteoporosis. Strontium ranelate, available outside the USA, has both anti-resorptive and anabolic properties. Supplementation with calcium and vitamin D is recommended for all women aged 50 years and older. Bisphosphonates are often considered first-line therapy for osteoporosis and have the largest base of clinical trial data showing efficacy for global fracture risk reduction. Low-dose hormone therapy is appropriate for younger women who are experiencing other menopausal symptoms. In women for whom bisphosphonates are not appropriate or not tolerated or in younger postmenopausal women who have a low risk for hip fracture, SERMs are a suitable treatment option. Calcitonin is designated for patients who are unable or unwilling to tolerate other osteoporosis agents. Emerging options, including newer SERMs (e.g., bazedoxifene and lasofoxifene) and the monoclonal antibody denosumab, may hold promise for providing protection from bone loss and for fracture risk reduction. Because no single agent is appropriate for all patients, treatment decisions should be made on an individual basis, taking into account the relative benefits and risks in different patient populations.

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Adverse events reported by postmenopausal women in controlled trials with raloxifene

Abstract: Raloxifene had an adverse event profile distinct from HRT and unopposed estrogen and was well tolerated by postmenopausal women.

Cited by 148 publications

References 20 publications

SERMs and SERMs with estrogen for postmenopausal osteoporosis

SERMs and SERMs with estrogen for postmenopausal osteoporosis

The effect of raloxifene in association with vitamin D on vaginal maturation index and urogenital symptoms in postmenopausal osteoporotic women

What is the best balance of benefits and risks among anti-resorptive therapies for postmenopausal osteoporosis?

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