Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 0.45 mg conjugated estrogens and 20 mg bazedoxifene) |
Drug Class | Conjugated estrogens with an estrogen agonist/antagonist |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in women with a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause.
- Indicated in women with a uterus for the prevention of postmenopausal osteoporosis.
Latest News
Summary
- Duavee (conjugated estrogens/bazedoxifene) is indicated in women with a uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Fezolinetant 45 mg significantly reduced the frequency of moderate to severe vasomotor symptoms (VMS) compared to non-hormonal therapies (paroxetine, desvenlafaxine, gabapentin ER) and placebo but did not show significant differences compared to hormone therapy (HT) regimens. It was less effective than tibolone 2.5 mg in reducing VMS severity.
- Bazedoxifene (BZA) 20 mg plus conjugated estrogens (CE) 0.625 mg significantly reduced the daily number of hot flushes, improved sleep disturbances, and enhanced total Menopause-Specific Quality of Life (MENQOL) compared to placebo, with greater effectiveness noted for the higher dosage compared to BZA 20 mg/CE 0.45 mg.
- BZA/CE demonstrated significant benefits for sleep disturbances associated with vasomotor symptoms compared to placebo/control, with similar effectiveness to gabapentin and oral combined hormone therapy.
- Dropout rates due to adverse events were comparable between BZA/CE and placebo/control, while eszopiclone and oral combined hormone therapy showed higher rates of discontinuation due to adverse events.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Duavee (conjugated estrogens/bazedoxifene) Prescribing Information. | 2024 | Wyeth Pharmaceuticals LLC, Philadelphia PA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The Art of Hormone Replacement Therapy (HRT) in Menopause Management. | 2023 | Journal of Pharmacy Practice |
Selective Estrogen Receptor Modulators in Gynecology Practice. | 2021 | Clinical Obstetrics and Gynecology |
Guideline No. 422f: Menopause and Breast Cancer. | 2021 | Journal of Obstetrics and Gynaecology Canada |