Efficacy and safety of bazedoxifene for postmenopausal osteoporosis

Hisaya Kawate, Ryoichi TakayanagiDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanAbstract: Bazedoxifene, a novel selective estrogen receptor modulator, has been developed to have favorable effects on bone and the lipid profile w...

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Autores principales: Kawate H, Takayanagi R
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Lenguaje:EN
Publicado: Dove Medical Press 2011
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Acceso en línea:https://doaj.org/article/a20acec5398f45c3a04962dcb0ec23be
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spelling oai:doaj.org-article:a20acec5398f45c3a04962dcb0ec23be2021-12-02T08:10:37ZEfficacy and safety of bazedoxifene for postmenopausal osteoporosis1178-1998https://doaj.org/article/a20acec5398f45c3a04962dcb0ec23be2011-06-01T00:00:00Zhttps://www.dovepress.com/efficacy-and-safety-of-bazedoxifene-for-postmenopausal-osteoporosis-peer-reviewed-article-CIAhttps://doaj.org/toc/1178-1998Hisaya Kawate, Ryoichi TakayanagiDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanAbstract: Bazedoxifene, a novel selective estrogen receptor modulator, has been developed to have favorable effects on bone and the lipid profile while minimizing stimulation of uterine or breast tissues. Two large Phase III clinical trials showed that bazedoxifene, as well as raloxifene, increased bone mineral density, decreased levels of bone turnover markers, and significantly reduced the risk of new vertebral fractures in postmenopausal women compared with placebo. Although the incidence of nonvertebral fractures with bazedoxifene or raloxifene did not differ significantly from that with placebo, a post hoc analysis of a subgroup of women at higher fracture risk revealed that bazedoxifene significantly reduced the nonvertebral fracture risk relative to placebo and raloxifene. Bazedoxifene also improved the lipid profile by reducing the serum concentrations of total cholesterol and low-density lipoprotein cholesterol, with an increase in the serum level of high-density lipoprotein cholesterol. The incidences of vasodilatation (hot flushes), leg cramps, and venous thromboembolic events were significantly higher with bazedoxifene and raloxifene compared with placebo. There was no evidence of endometrial and breast stimulation with bazedoxifene. Taking advantage of the favorable effects of bazedoxifene on the breast and endometrium, the pairing of bazedoxifene with conjugated estrogens is under investigation for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis. A Phase III trial showed that combination therapy of bazedoxifene and conjugated estrogens significantly increased bone mineral density and decreased bone turnover markers, with relief of hot flushes and improvement of vaginal atrophy. This article reviews the clinical efficacy and safety of bazedoxifene in the treatment of postmenopausal osteoporosis.Keywords: selective estrogen receptor modulators, osteoporosis, estrogen receptor, nonvertebral fracture, endometriumKawate HTakayanagi RDove Medical PressarticleSERMosteoporosisestrogen receptornonvertebral fractureendometriumGeriatricsRC952-954.6ENClinical Interventions in Aging, Vol Volume 6, Pp 151-160 (2011)
institution DOAJ
collection DOAJ
language EN
topic SERM
osteoporosis
estrogen receptor
nonvertebral fracture
endometrium
Geriatrics
RC952-954.6
spellingShingle SERM
osteoporosis
estrogen receptor
nonvertebral fracture
endometrium
Geriatrics
RC952-954.6
Kawate H
Takayanagi R
Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
description Hisaya Kawate, Ryoichi TakayanagiDepartment of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanAbstract: Bazedoxifene, a novel selective estrogen receptor modulator, has been developed to have favorable effects on bone and the lipid profile while minimizing stimulation of uterine or breast tissues. Two large Phase III clinical trials showed that bazedoxifene, as well as raloxifene, increased bone mineral density, decreased levels of bone turnover markers, and significantly reduced the risk of new vertebral fractures in postmenopausal women compared with placebo. Although the incidence of nonvertebral fractures with bazedoxifene or raloxifene did not differ significantly from that with placebo, a post hoc analysis of a subgroup of women at higher fracture risk revealed that bazedoxifene significantly reduced the nonvertebral fracture risk relative to placebo and raloxifene. Bazedoxifene also improved the lipid profile by reducing the serum concentrations of total cholesterol and low-density lipoprotein cholesterol, with an increase in the serum level of high-density lipoprotein cholesterol. The incidences of vasodilatation (hot flushes), leg cramps, and venous thromboembolic events were significantly higher with bazedoxifene and raloxifene compared with placebo. There was no evidence of endometrial and breast stimulation with bazedoxifene. Taking advantage of the favorable effects of bazedoxifene on the breast and endometrium, the pairing of bazedoxifene with conjugated estrogens is under investigation for the treatment of menopausal symptoms and prevention of postmenopausal osteoporosis. A Phase III trial showed that combination therapy of bazedoxifene and conjugated estrogens significantly increased bone mineral density and decreased bone turnover markers, with relief of hot flushes and improvement of vaginal atrophy. This article reviews the clinical efficacy and safety of bazedoxifene in the treatment of postmenopausal osteoporosis.Keywords: selective estrogen receptor modulators, osteoporosis, estrogen receptor, nonvertebral fracture, endometrium
format article
author Kawate H
Takayanagi R
author_facet Kawate H
Takayanagi R
author_sort Kawate H
title Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
title_short Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
title_full Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
title_fullStr Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
title_full_unstemmed Efficacy and safety of bazedoxifene for postmenopausal osteoporosis
title_sort efficacy and safety of bazedoxifene for postmenopausal osteoporosis
publisher Dove Medical Press
publishDate 2011
url https://doaj.org/article/a20acec5398f45c3a04962dcb0ec23be
work_keys_str_mv AT kawateh efficacyandsafetyofbazedoxifeneforpostmenopausalosteoporosis
AT takayanagir efficacyandsafetyofbazedoxifeneforpostmenopausalosteoporosis
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