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James H Pickar - One of the best experts on this subject based on the ideXlab platform.
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Selective estrogen receptor modulators and the combination therapy Conjugated Estrogens/bazedoxifene: A review of effects on the breast
Post reproductive health, 2015Co-Authors: James H Pickar, Barry S. KommAbstract:Traditional menopausal hormone therapy containing Estrogens/progestin has been associated with an increased risk of breast cancer, and estrogen exposure is known to promote growth and proliferation of a majority of breast cancers. Therefore, it is important for clinicians to consider the breast safety profile of any hormone-based therapy used in postmenopausal women. This review provides an overview of the breast safety and tolerability profiles of currently marketed selective estrogen receptor modulators, antiEstrogens, and the first tissue selective estrogen complex combining Conjugated Estrogens with the selective estrogen receptor modulator bazedoxifene in postmenopausal women. Selective estrogen receptor modulators and antiEstrogens act as estrogen receptor antagonists in the breast. Tamoxifen, toremifene, and the selective estrogen receptor degrader fulvestrant are used to treat breast cancer, and tamoxifen and raloxifene protect against breast cancer in high-risk women. Postmenopausal women using selective estrogen receptor modulators for prevention or treatment of osteoporosis (raloxifene, bazedoxifene) can be reassured that these hormonal treatments do not adversely affect their risk of breast cancer and may, in the case of raloxifene, even be protective. There are limited data on breast cancer in women who use ospemifene for dyspareunia. Conjugated Estrogens/bazedoxifene use for up to two years did not increase mammographic breast density or breast pain/tenderness, and there was no evidence of an increased risk of breast cancer, suggesting that Conjugated Estrogens/bazedoxifene has an improved breast safety profile compared with traditional menopausal hormone therapies. Future research will continue to focus on development of selective estrogen receptor modulators and selective estrogen receptor modulator combinations capable of achieving the ideal balance of estrogen receptor agonist and antagonist effects.
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selective estrogen receptor modulators and the combination therapy Conjugated Estrogens bazedoxifene a review of effects on the breast
Post Reproductive Health: The Journal of The British Menopause Society, 2015Co-Authors: James H Pickar, Barry S. KommAbstract:Traditional menopausal hormone therapy containing Estrogens/progestin has been associated with an increased risk of breast cancer, and estrogen exposure is known to promote growth and proliferation of a majority of breast cancers. Therefore, it is important for clinicians to consider the breast safety profile of any hormone-based therapy used in postmenopausal women. This review provides an overview of the breast safety and tolerability profiles of currently marketed selective estrogen receptor modulators, antiEstrogens, and the first tissue selective estrogen complex combining Conjugated Estrogens with the selective estrogen receptor modulator bazedoxifene in postmenopausal women. Selective estrogen receptor modulators and antiEstrogens act as estrogen receptor antagonists in the breast. Tamoxifen, toremifene, and the selective estrogen receptor degrader fulvestrant are used to treat breast cancer, and tamoxifen and raloxifene protect against breast cancer in high-risk women. Postmenopausal women using selective estrogen receptor modulators for prevention or treatment of osteoporosis (raloxifene, bazedoxifene) can be reassured that these hormonal treatments do not adversely affect their risk of breast cancer and may, in the case of raloxifene, even be protective. There are limited data on breast cancer in women who use ospemifene for dyspareunia. Conjugated Estrogens/bazedoxifene use for up to two years did not increase mammographic breast density or breast pain/tenderness, and there was no evidence of an increased risk of breast cancer, suggesting that Conjugated Estrogens/bazedoxifene has an improved breast safety profile compared with traditional menopausal hormone therapies. Future research will continue to focus on development of selective estrogen receptor modulators and selective estrogen receptor modulator combinations capable of achieving the ideal balance of estrogen receptor agonist and antagonist effects.
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bazedoxifene Conjugated Estrogens for menopausal symptom treatment and osteoporosis prevention
Climacteric, 2012Co-Authors: Joann V. Pinkerton, James H Pickar, Jill Racketa, Sebastian MirkinAbstract:ABSTRACTPostmenopausal women with vasomotor and vaginal symptoms are commonly treated with Estrogens or combined estrogen/progestin therapy (hormone therapy). However, hormone therapy is associated with some safety and tolerability concerns and its benefit/risk profile may vary for women based on their time since menopause. The tissue selective estrogen complex (TSEC) pairs a selective estrogen receptor modulator with one or more Estrogens, with the goal of relieving menopausal symptoms and preserving bone mineral density without stimulating the breast or endometrium. Bazedoxifene/Conjugated Estrogens (BZA/CE) is the first TSEC in clinical development. BZA 20 mg/CE 0.45 and 0.625 mg have been shown in phase-3 clinical trials to significantly improve hot flushes and vulvar/vaginal atrophy measures in symptomatic postmenopausal women and to prevent bone loss in postmenopausal women at risk for osteoporosis while ensuring endometrial safety. These doses of BZA/CE have also demonstrated significant improvemen...
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bazedoxifene Conjugated Estrogens bza ce incidence of uterine bleeding in postmenopausal women
Fertility and Sterility, 2009Co-Authors: David F. Archer, Sophie Olivier, Vivian Lewis, Bruce R Carr, James H PickarAbstract:Objective To evaluate the effect of bazedoxifene/Conjugated Estrogens (BZA/CE), a tissue selective estrogen complex, on uterine bleeding in postmenopausal women. Design International, multicenter, randomized, double-blind, placebo- and active-controlled, phase III study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting Outpatient clinical. Patient(s) Healthy, postmenopausal women (N = 3,397) aged 40 to 75 years with an intact uterus. Intervention(s) Daily oral therapy with BZA 10, 20, or 40 mg, each with CE 0.625 or 0.45 mg, raloxifene 60 mg, or placebo. Main Outcome Measure(s) Cumulative amenorrhea profiles and the incidence of bleeding or spotting over 2 years. Result(s) Treatment with BZA 20 or 40 mg with CE 0.625 or 0.45 mg was associated with rates of cumulative amenorrhea (>83% during cycles 1–13 and >93% during cycles 10–13) and bleeding or spotting that were comparable to those with placebo. Subjects who received BZA 10 mg/CE 0.625 mg experienced slightly lower cumulative amenorrhea rates throughout the study compared with placebo-treated subjects. Conclusion(s) Postmenopausal women treated with BZA 20 or 40 mg with CE 0.625 or 0.45 mg had high rates of cumulative amenorrhea that were similar to those reported with placebo. This new menopausal therapy may offer a favorable bleeding and tolerability profile.
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endometrial effects of a tissue selective estrogen complex containing bazedoxifene Conjugated Estrogens as a menopausal therapy
Fertility and Sterility, 2009Co-Authors: James H Pickar, Gloria Bachmann, L SperoffAbstract:Objective To evaluate the endometrial safety of a tissue selective estrogen complex (TSEC; pairing of a selective estrogen receptor modulator [SERM] with Estrogens) composed of bazedoxifene/Conjugated Estrogens (BZA/CE) in postmenopausal women. Design Randomized, double-blind, multicenter, placebo- and active-controlled, phase 3 study (Selective estrogen Menopause And Response to Therapy [SMART]-1). Setting Outpatient clinical. Patient(s) Healthy, postmenopausal women (n = 3,397) age 40–75 with an intact uterus. Intervention(s) Single tablets of BZA (10, 20, or 40 mg) combined with CE (0.625 or 0.45 mg); raloxifene (60 mg); or placebo daily for 2 years. Main Outcome Measure(s) Incidence of endometrial hyperplasia at 12 months in the efficacy evaluable population. Result(s) Treatment with BZA (20 or 40 mg)/CE (0.625 or 0.45 mg) was associated with low rates ( Conclusion(s) When combined with CE (0.625 mg or 0.45 mg), BZA (20 mg) was the lowest effective dose that prevented endometrial hyperplasia over 2 years of study, creating the possibility for a new, progestin-free menopausal therapy.
Joann V. Pinkerton - One of the best experts on this subject based on the ideXlab platform.
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timing and persistence of effect of Conjugated Estrogens bazedoxifene in postmenopausal women
Menopause, 2016Co-Authors: Risa Kagan, Barry S. Komm, Kelly A. Ryan, Joanne Lavenberg, Joann V. PinkertonAbstract:OBJECTIVE The aim of the study was to determine the time course of effect with Conjugated Estrogens/bazedoxifene (CE/BZA) in nonhysterectomized postmenopausal women in five phase 3 trials. METHODS This post hoc analysis identified when CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg first achieved a statistically significant difference (P < 0.05) versus placebo in individual trials and the duration the difference persisted for prespecified efficacy endpoints. RESULTS CE/BZA significantly reduced hot flush frequency beginning at weeks 2 to 4 and severity at weeks 3 to 6; benefits were maintained through month 24. Significant improvements in lumbar spine, total hip, femoral neck, and femoral trochanter bone mineral density were evident at month 6 or 12 and changes in bone turnover markers at month 3 or 6; benefits were maintained throughout the studies (12 or 24 mo). In symptomatic women with less than 5% vaginal superficial cells at baseline, vaginal maturation index was significantly improved by week 4. Reductions in parabasal cells were maintained throughout the studies (through months 3 and 24), but superficial cell count changes persisted only with the higher CE/BZA dose. Menopause-Specific Quality of Life total and vasomotor domain scores were improved at all assessments, from months 3 through 24. Some measures of sleep, especially quality and time to fall asleep, improved during weeks 4 to 8 and were maintained in a majority of weeks thereafter. CONCLUSIONS In the context of studies designed primarily to evaluate efficacy at final study endpoints, both doses of CE/BZA achieved significance versus placebo at early assessments for most outcomes, and benefits were well maintained.
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sleep parameters and health related quality of life with bazedoxifene Conjugated Estrogens a randomized trial
Menopause, 2014Co-Authors: Joann V. Pinkerton, Kaijie Pan, Kelly A. Ryan, Arkadi Chines, Lucy Abraham, Jill Racketa, Sebastian MirkinAbstract:AbstractObjectiveThe effects of bazedoxifene (BZA)/Conjugated Estrogens (CE) on sleep and health-related quality of life (HRQoL) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized, double-blind, placebo- and active-controlled phase 3 trial.MethodsThe sleep/HR
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effects of bazedoxifene Conjugated Estrogens on the endometrium and bone a randomized trial
The Journal of Clinical Endocrinology and Metabolism, 2014Co-Authors: Joann V. Pinkerton, Jennifer A. Harvey, Kaijie Pan, Arkadi Chines, Sebastian Mirkin, David F. Archer, Robert Lindsay, Smart InvestigatorsAbstract:Objective: This phase 3 study evaluated the endometrial safety of bazedoxifene (BZA)/Conjugated Estrogens (CE) and bone mineral density (BMD) effects vs BZA alone, hormone therapy, and placebo (PBO). Methods: The Selective Estrogens, Menopause, And Response to Therapy (SMART)-5 trial was a multicenter, randomized, double-blind, PBO- and active-controlled study in postmenopausal women with an intact uterus (N = 1843; aged 40–65 years) seeking treatment for menopausal symptoms. Subjects received daily oral BZA 20 mg/CE 0.45 or 0.625 mg, BZA 20 mg, CE 0.45 mg/medroxyprogesterone acetate (MPA) 1.5 mg, or PBO. Primary endpoints were incidence of endometrial hyperplasia and percent change in lumbar spine BMD at 12 months. Secondary endpoints included additional osteoporosis parameters and assessments of tolerability and safety. Results: At 12 months, endometrial hyperplasia incidence was low (<1%) and similar among groups. The BZA/CE group showed significantly greater increases in lumbar spine and total hip BMD...
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tissue selective estrogen complex combinations with bazedoxifene Conjugated Estrogens as a model
Climacteric, 2013Co-Authors: Joann V. Pinkerton, Barry S. Komm, Sebastian MirkinAbstract:AbstractThe tissue selective estrogen complex (TSEC) pairs a selective estrogen receptor modulator (SERM) with one or more Estrogens. Different TSECs are associated with distinct gene expression profiles in mammary gland and endometrial tissue according to the individual SERM and estrogen components. Few TSECs have been evaluated outside the laboratory. In preclinical trials, bazedoxifene (BZA) was distinct from other SERMs, with a neutral effect on mammary gland and endometrial tissue, and an antagonist effect on these tissues when combined with Conjugated Estrogens (CE). The only TSEC in an advanced stage of clinical development pairs BZA with CE. In large, randomized clinical trials, two doses, BZA 20 mg/CE 0.45 and 0.625 mg, reduced menopausal symptoms and prevented bone loss in postmenopausal women with a favorable safety profile on the breast, endometrium, and ovary, and with cardiovascular and venous thrombosis events similar to placebo. Improvements were seen in sleep, health-related quality of li...
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Breast Effects of Bazedoxifene-Conjugated Estrogens: A Randomized Controlled Trial
Obstetrics and gynecology, 2013Co-Authors: Joann V. Pinkerton, Jennifer A. Harvey, Kaijie Pan, John R. Thompson, Kelly A. Ryan, Arkadi Chines, Sebastian MirkinAbstract:OBJECTIVE:To evaluate the effects of bazedoxifene-Conjugated Estrogens on mammographic breast density and other breast parameters in nonhysterectomized postmenopausal women enrolled in a randomized, double-blind, placebo-controlled, and active-controlled phase 3 study.METHODS:The 1-year Selective es
Sebastian Mirkin - One of the best experts on this subject based on the ideXlab platform.
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effects of Conjugated Estrogens bazedoxifene on lipid and coagulation variables a randomized placebo and active controlled trial
Menopause, 2015Co-Authors: Sven O Skouby, Barry S. Komm, Kaijie Pan, John R. Thompson, Sebastian MirkinAbstract:AbstractObjectiveThis study aims to evaluate the effects of Conjugated Estrogens (CE)/bazedoxifene (BZA) on lipid and coagulation variables in a randomized, double-blind, placebo- and active-controlled phase 3 study of nonhysterectomized postmenopausal women.MethodsThe Selective Estrogens, Menopause
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sleep parameters and health related quality of life with bazedoxifene Conjugated Estrogens a randomized trial
Menopause, 2014Co-Authors: Joann V. Pinkerton, Kaijie Pan, Kelly A. Ryan, Arkadi Chines, Lucy Abraham, Jill Racketa, Sebastian MirkinAbstract:AbstractObjectiveThe effects of bazedoxifene (BZA)/Conjugated Estrogens (CE) on sleep and health-related quality of life (HRQoL) were evaluated in nonhysterectomized postmenopausal women who were enrolled in a randomized, double-blind, placebo- and active-controlled phase 3 trial.MethodsThe sleep/HR
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effects of bazedoxifene Conjugated Estrogens on the endometrium and bone a randomized trial
The Journal of Clinical Endocrinology and Metabolism, 2014Co-Authors: Joann V. Pinkerton, Jennifer A. Harvey, Kaijie Pan, Arkadi Chines, Sebastian Mirkin, David F. Archer, Robert Lindsay, Smart InvestigatorsAbstract:Objective: This phase 3 study evaluated the endometrial safety of bazedoxifene (BZA)/Conjugated Estrogens (CE) and bone mineral density (BMD) effects vs BZA alone, hormone therapy, and placebo (PBO). Methods: The Selective Estrogens, Menopause, And Response to Therapy (SMART)-5 trial was a multicenter, randomized, double-blind, PBO- and active-controlled study in postmenopausal women with an intact uterus (N = 1843; aged 40–65 years) seeking treatment for menopausal symptoms. Subjects received daily oral BZA 20 mg/CE 0.45 or 0.625 mg, BZA 20 mg, CE 0.45 mg/medroxyprogesterone acetate (MPA) 1.5 mg, or PBO. Primary endpoints were incidence of endometrial hyperplasia and percent change in lumbar spine BMD at 12 months. Secondary endpoints included additional osteoporosis parameters and assessments of tolerability and safety. Results: At 12 months, endometrial hyperplasia incidence was low (<1%) and similar among groups. The BZA/CE group showed significantly greater increases in lumbar spine and total hip BMD...
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bazedoxifene Conjugated Estrogens for managing the burden of estrogen deficiency symptoms
Maturitas, 2014Co-Authors: Sebastian Mirkin, Kelly A. Ryan, Arthi Chandran, Barry S. KommAbstract:Abstract The bothersome vasomotor and vaginal symptoms and bone loss that accompany the menopausal transition are associated with significant direct costs due to physician visits and medication, as well as indirect costs from reduced health-related quality of life (HRQoL) and work productivity. With life expectancies increasing, the number of postmenopausal women is also increasing, and more women are remaining in the workforce. These factors have led to an increased burden of menopausal symptoms on healthcare systems. Hormone therapy (HT) has been shown to effectively reduce menopausal symptoms and significantly increase quality-adjusted life years in postmenopausal women, particularly in women experiencing severe symptoms. However, many women discontinue use of HT before their symptoms have dissipated due to safety and tolerability concerns. The tissue selective estrogen complex (TSEC) that pairs bazedoxifene (BZA) with Conjugated Estrogens (CE) has been developed to provide relief of menopausal symptoms and prevent bone loss without stimulating the breast or endometrium, and to have improved tolerability compared with HT. In this context, BZA 20 mg/CE 0.45 and 0.625 mg were shown to prevent bone loss and effectively treat menopausal symptoms in postmenopausal women with an intact uterus, while also demonstrating a favorable safety/tolerability profile. BZA 20 mg/CE 0.45 and 0.625 mg were further associated with clinically significant improvements in HRQoL, sleep, and treatment satisfaction. Taken together, the reduction in menopausal symptoms, improvement in HRQoL, and favorable safety/tolerability profile associated with BZA/CE suggest that it is a cost-effective alternative to HT for managing the burden of menopausal symptoms.
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tissue selective estrogen complex combinations with bazedoxifene Conjugated Estrogens as a model
Climacteric, 2013Co-Authors: Joann V. Pinkerton, Barry S. Komm, Sebastian MirkinAbstract:AbstractThe tissue selective estrogen complex (TSEC) pairs a selective estrogen receptor modulator (SERM) with one or more Estrogens. Different TSECs are associated with distinct gene expression profiles in mammary gland and endometrial tissue according to the individual SERM and estrogen components. Few TSECs have been evaluated outside the laboratory. In preclinical trials, bazedoxifene (BZA) was distinct from other SERMs, with a neutral effect on mammary gland and endometrial tissue, and an antagonist effect on these tissues when combined with Conjugated Estrogens (CE). The only TSEC in an advanced stage of clinical development pairs BZA with CE. In large, randomized clinical trials, two doses, BZA 20 mg/CE 0.45 and 0.625 mg, reduced menopausal symptoms and prevented bone loss in postmenopausal women with a favorable safety profile on the breast, endometrium, and ovary, and with cardiovascular and venous thrombosis events similar to placebo. Improvements were seen in sleep, health-related quality of li...
Barry S. Komm - One of the best experts on this subject based on the ideXlab platform.
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timing and persistence of effect of Conjugated Estrogens bazedoxifene in postmenopausal women
Menopause, 2016Co-Authors: Risa Kagan, Barry S. Komm, Kelly A. Ryan, Joanne Lavenberg, Joann V. PinkertonAbstract:OBJECTIVE The aim of the study was to determine the time course of effect with Conjugated Estrogens/bazedoxifene (CE/BZA) in nonhysterectomized postmenopausal women in five phase 3 trials. METHODS This post hoc analysis identified when CE 0.45 mg/BZA 20 mg and CE 0.625 mg/BZA 20 mg first achieved a statistically significant difference (P < 0.05) versus placebo in individual trials and the duration the difference persisted for prespecified efficacy endpoints. RESULTS CE/BZA significantly reduced hot flush frequency beginning at weeks 2 to 4 and severity at weeks 3 to 6; benefits were maintained through month 24. Significant improvements in lumbar spine, total hip, femoral neck, and femoral trochanter bone mineral density were evident at month 6 or 12 and changes in bone turnover markers at month 3 or 6; benefits were maintained throughout the studies (12 or 24 mo). In symptomatic women with less than 5% vaginal superficial cells at baseline, vaginal maturation index was significantly improved by week 4. Reductions in parabasal cells were maintained throughout the studies (through months 3 and 24), but superficial cell count changes persisted only with the higher CE/BZA dose. Menopause-Specific Quality of Life total and vasomotor domain scores were improved at all assessments, from months 3 through 24. Some measures of sleep, especially quality and time to fall asleep, improved during weeks 4 to 8 and were maintained in a majority of weeks thereafter. CONCLUSIONS In the context of studies designed primarily to evaluate efficacy at final study endpoints, both doses of CE/BZA achieved significance versus placebo at early assessments for most outcomes, and benefits were well maintained.
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Selective estrogen receptor modulators and the combination therapy Conjugated Estrogens/bazedoxifene: A review of effects on the breast
Post reproductive health, 2015Co-Authors: James H Pickar, Barry S. KommAbstract:Traditional menopausal hormone therapy containing Estrogens/progestin has been associated with an increased risk of breast cancer, and estrogen exposure is known to promote growth and proliferation of a majority of breast cancers. Therefore, it is important for clinicians to consider the breast safety profile of any hormone-based therapy used in postmenopausal women. This review provides an overview of the breast safety and tolerability profiles of currently marketed selective estrogen receptor modulators, antiEstrogens, and the first tissue selective estrogen complex combining Conjugated Estrogens with the selective estrogen receptor modulator bazedoxifene in postmenopausal women. Selective estrogen receptor modulators and antiEstrogens act as estrogen receptor antagonists in the breast. Tamoxifen, toremifene, and the selective estrogen receptor degrader fulvestrant are used to treat breast cancer, and tamoxifen and raloxifene protect against breast cancer in high-risk women. Postmenopausal women using selective estrogen receptor modulators for prevention or treatment of osteoporosis (raloxifene, bazedoxifene) can be reassured that these hormonal treatments do not adversely affect their risk of breast cancer and may, in the case of raloxifene, even be protective. There are limited data on breast cancer in women who use ospemifene for dyspareunia. Conjugated Estrogens/bazedoxifene use for up to two years did not increase mammographic breast density or breast pain/tenderness, and there was no evidence of an increased risk of breast cancer, suggesting that Conjugated Estrogens/bazedoxifene has an improved breast safety profile compared with traditional menopausal hormone therapies. Future research will continue to focus on development of selective estrogen receptor modulators and selective estrogen receptor modulator combinations capable of achieving the ideal balance of estrogen receptor agonist and antagonist effects.
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selective estrogen receptor modulators and the combination therapy Conjugated Estrogens bazedoxifene a review of effects on the breast
Post Reproductive Health: The Journal of The British Menopause Society, 2015Co-Authors: James H Pickar, Barry S. KommAbstract:Traditional menopausal hormone therapy containing Estrogens/progestin has been associated with an increased risk of breast cancer, and estrogen exposure is known to promote growth and proliferation of a majority of breast cancers. Therefore, it is important for clinicians to consider the breast safety profile of any hormone-based therapy used in postmenopausal women. This review provides an overview of the breast safety and tolerability profiles of currently marketed selective estrogen receptor modulators, antiEstrogens, and the first tissue selective estrogen complex combining Conjugated Estrogens with the selective estrogen receptor modulator bazedoxifene in postmenopausal women. Selective estrogen receptor modulators and antiEstrogens act as estrogen receptor antagonists in the breast. Tamoxifen, toremifene, and the selective estrogen receptor degrader fulvestrant are used to treat breast cancer, and tamoxifen and raloxifene protect against breast cancer in high-risk women. Postmenopausal women using selective estrogen receptor modulators for prevention or treatment of osteoporosis (raloxifene, bazedoxifene) can be reassured that these hormonal treatments do not adversely affect their risk of breast cancer and may, in the case of raloxifene, even be protective. There are limited data on breast cancer in women who use ospemifene for dyspareunia. Conjugated Estrogens/bazedoxifene use for up to two years did not increase mammographic breast density or breast pain/tenderness, and there was no evidence of an increased risk of breast cancer, suggesting that Conjugated Estrogens/bazedoxifene has an improved breast safety profile compared with traditional menopausal hormone therapies. Future research will continue to focus on development of selective estrogen receptor modulators and selective estrogen receptor modulator combinations capable of achieving the ideal balance of estrogen receptor agonist and antagonist effects.
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effects of Conjugated Estrogens bazedoxifene on lipid and coagulation variables a randomized placebo and active controlled trial
Menopause, 2015Co-Authors: Sven O Skouby, Barry S. Komm, Kaijie Pan, John R. Thompson, Sebastian MirkinAbstract:AbstractObjectiveThis study aims to evaluate the effects of Conjugated Estrogens (CE)/bazedoxifene (BZA) on lipid and coagulation variables in a randomized, double-blind, placebo- and active-controlled phase 3 study of nonhysterectomized postmenopausal women.MethodsThe Selective Estrogens, Menopause
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bazedoxifene Conjugated Estrogens for managing the burden of estrogen deficiency symptoms
Maturitas, 2014Co-Authors: Sebastian Mirkin, Kelly A. Ryan, Arthi Chandran, Barry S. KommAbstract:Abstract The bothersome vasomotor and vaginal symptoms and bone loss that accompany the menopausal transition are associated with significant direct costs due to physician visits and medication, as well as indirect costs from reduced health-related quality of life (HRQoL) and work productivity. With life expectancies increasing, the number of postmenopausal women is also increasing, and more women are remaining in the workforce. These factors have led to an increased burden of menopausal symptoms on healthcare systems. Hormone therapy (HT) has been shown to effectively reduce menopausal symptoms and significantly increase quality-adjusted life years in postmenopausal women, particularly in women experiencing severe symptoms. However, many women discontinue use of HT before their symptoms have dissipated due to safety and tolerability concerns. The tissue selective estrogen complex (TSEC) that pairs bazedoxifene (BZA) with Conjugated Estrogens (CE) has been developed to provide relief of menopausal symptoms and prevent bone loss without stimulating the breast or endometrium, and to have improved tolerability compared with HT. In this context, BZA 20 mg/CE 0.45 and 0.625 mg were shown to prevent bone loss and effectively treat menopausal symptoms in postmenopausal women with an intact uterus, while also demonstrating a favorable safety/tolerability profile. BZA 20 mg/CE 0.45 and 0.625 mg were further associated with clinically significant improvements in HRQoL, sleep, and treatment satisfaction. Taken together, the reduction in menopausal symptoms, improvement in HRQoL, and favorable safety/tolerability profile associated with BZA/CE suggest that it is a cost-effective alternative to HT for managing the burden of menopausal symptoms.
Howard Hait - One of the best experts on this subject based on the ideXlab platform.
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synthetic Conjugated Estrogens b and postmenopausal nocturnal vasomotor symptoms a randomized controlled trial
Obstetrics & Gynecology, 2012Co-Authors: Kathleen Z Reape, Howard HaitAbstract:OBJECTIVE:To evaluate two doses of oral synthetic Conjugated Estrogens-B tablets compared with placebo on the frequency of awakenings resulting from nocturnal vasomotor symptoms in postmenopausal women over a 12-week treatment period.METHODS:A double-blind, randomized, placebo-controlled multicenter
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twice weekly synthetic Conjugated Estrogens vaginal cream for the treatment of vaginal atrophy
Menopause, 2009Co-Authors: Murray Freedman, Kathleen Z Reape, Andrew M Kaunitz, Howard HaitAbstract:Objective: The aim of this study was to evaluate low-dose synthetic Conjugated Estrogens A (SCE-A) cream administered twice weekly for the treatment of moderate to severe vulvovaginal atrophy (VVA) in a symptomatic postmenopausal population. Methods: In a multicenter, double-blind, randomized, placebo-controlled study, 305 women with symptoms of VVA were treated with either 1 g SCE-A cream (n = 150) or matching placebo (n = 155) for a period of up to 12 weeks. Participants had to have a vaginal pH of greater than 5, less than or equal to 5% superficial cells on a vaginal smear, and at least one of five symptoms of WA (dryness, soreness, irritation, pain with intercourse, and bleeding after intercourse) that was moderate or severe in intensity. Women had to select one moderate or severe symptom as the most bothersome. Results: Efficacy was assessed at 2, 3, 4, 8, and 12 weeks and included the change from baseline in the severity of the most bothersome symptom (MBS), maturation index, and pH. Most women identified vaginal dryness as the MBS (48%) followed by pain with intercourse (31.3%). A statistically significant increase in the maturation index and significant decreases in pH and severity of the MBS were observed for those treated with SCE-A vaginal cream compared with placebo. Conclusions: A low dose (1 g = 0.625 mg) of SCE-A vaginal cream administered twice weekly was shown to be effective compared with placebo in treating VVA in postmenopausal women for the three coprimary efficacy measures of maturation index, pH, and severity of the MBS.
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randomized multicenter double blind placebo controlled trial to evaluate the efficacy and safety of synthetic Conjugated Estrogens b for the treatment of vulvovaginal atrophy in healthy postmenopausal women
Fertility and Sterility, 2008Co-Authors: James A Simon, Kathleen Z Reape, Steve Wininger, Howard HaitAbstract:Objective To evaluate the safety and efficacy of synthetic Conjugated Estrogens B (SCE-B; 0.3 mg/d) for 12 weeks in the treatment of vulvovaginal atrophy in symptomatic, postmenopausal women. Design Prospective, randomized, multicenter, double-blind, placebo-controlled trial. Setting Forty-two participating sites in the United States. Patient(s) Postmenopausal women with at least one moderate to severe symptom of vaginal atrophy. Intervention(s) Daily oral administration, in a randomized, placebo-controlled setting, of SCE-B (0.3 mg) or of placebo for 12 weeks. Main Outcome Measure(s) Mean changes in vaginal maturation index, percentage of parabasal and superficial cells, vaginal pH, and severity of the most bothersome symptom (MBS) between baseline and predetermined time points were assessed. Safety and tolerability were evaluated. Result(s) A total of 310 women (mean age, 58.6 y) were enrolled. Synthetic Conjugated Estrogens B yielded statistically significantly greater differences in vaginal maturation index and vaginal pH from baseline to the end of treatment. Vaginal dryness (44.4%) and pain during intercourse (30.2%) were the symptoms most commonly identified as the MBS. A statistically significant mean reduction in the severity of the MBS was noted for SCE-B. There were no clinically significant differences observed between the two groups for findings related to safety. Conclusion(s) Synthetic Conjugated Estrogens B (0.3 mg/d) was effective in treating vulvovaginal atrophy in symptomatic postmenopausal women. Significant improvement was seen in vaginal maturation index, vaginal pH, and severity of MBS from baseline to the end of treatment.