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Duavee (Conjugated Estrogens / Bazedoxifene Acetate) - Summary

 
 



WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, AND PROBABLE DEMENTIA

  • Women taking DUAVEE should not take additional estrogens [see Warnings and Precautions]
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. DUAVEE has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions]
  • Estrogen therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.2, 5.4) ]
  • The Women's Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (0.625 mg)-alone, relative to placebo [see Warnings and Precautions]
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily conjugated estrogens (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions]

In the absence of comparable data, these risks should be assumed to be similar for other doses of conjugated estrogens and other dosage forms of estrogens.

Estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

 

DUAVEE SUMMARY

DUAVEE (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist.

DUAVEE is indicated in women with a uterus for:

Treatment of Moderate to Severe Vasomotor Symptoms Associated with Menopause

Prevention of Postmenopausal Osteoporosis

Important Limitations of Use

  • Use DUAVEE for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary.
  • When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

See all Duavee indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Duavee (Conjugated Estrogens / Bazedoxifene)

Menopause-specific quality of life across varying menopausal populations with conjugated estrogens/bazedoxifene. [2014]
types in phase 3 clinical trials... CONCLUSIONS: CE/BZA significantly improved overall and vasomotor-related MSQOL

Effects of bazedoxifene/conjugated estrogens on the endometrium and bone: a randomized trial. [2014]
alone, hormone therapy, and placebo (PBO)... CONCLUSIONS: BZA/CE showed low rates of endometrial hyperplasia and improved

Sleep parameters and health-related quality of life with bazedoxifene/conjugated estrogens: a randomized trial. [2014]
and active-controlled phase 3 trial... CONCLUSIONS: Symptomatic postmenopausal women who are treated with BZA/CE for 1

Breast effects of bazedoxifene-conjugated estrogens: a randomized controlled trial. [2013]
and active-controlled phase 3 study... CONCLUSION: Bazedoxifene 20 mg and conjugated estrogens 0.45 and 0.625 mg did not

Preventing osteoporosis with a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens (BZA/CE). [2011]
Hormone therapy classically consists of an estrogen with an added progestin; however, concerns have been raised about the potential negative effects of progestin. The recent realization that estrogen agonist-antagonists or selective estrogen receptor modulators might be paired with estrogens instead of a progestin has led to the development of a novel form of menopausal therapy called tissue selective estrogen complex (TSEC).

more studies >>

Clinical Trials Related to Duavee (Conjugated Estrogens / Bazedoxifene)

Duavee Prevention of Metabolic Dysfunction in Postmenopausal Women [Not yet recruiting]
The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with DUAVEE vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center.

Study Evaluating Potential Drug Interaction Of Bazedoxifene & Premarin In Healthy Postmenopausal Women [Completed]
Bazedoxifene (BZA) 20 mg tablet is an investigational medication (not approved by FDA) which is being studied for possible prevention and treatment of postmenopausal osteoporosis. PREMARIN® (conjugated estrogens [CE]) is approved by FDA to treat moderate to severe symptoms of menopause (i. e., hot flashes, and/or vulvar and vaginal atrophy) and for the prevention of postmenopausal osteoporosis. The purpose of this study is to evaluate the pharmacokinetics (absorption, distribution, breakdown and elimination in the body) of a single dose of PREMARIN® when administered together with multiple doses of bazedoxifene (BZA) to healthy postmenopausal women. Information will also be obtained regarding the safety and tolerability of the study medications when given together to healthy postmenopausal women.

more trials >>


Page last updated: 2015-08-10

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