Drug updated on 4/24/2024
| 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.
Summary
- Conjugated estrogens/bazedoxifene (Duavee) is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and prevention of postmenopausal osteoporosis in women with a uterus.
- Three studies were reviewed, comparing Duavee's safety and effectiveness against other treatments for menopausal symptoms, specifically vasomotor symptoms and preventing postmenopausal osteoporosis.
- The first study suggests that Duavee has comparable efficacy to fezolinetant (a non-hormonal therapy) in reducing the frequency of vasomotor symptoms (VMS). It also indicates potential superior efficacy over other non-hormone therapies such as paroxetine, desvenlafaxine, and gabapentin.
- According to the second study, conjugated estrogens/bazedoxifene shows significant improvements in hot flushes, sleep disturbance, and menopause-related quality of life compared with placebo. A dose combination BZA 20mg/CE 0.625mg performs better than BZA 20mg/CE 0.45mg.
- The third study reveals that bazedoxifene-conjugated estrogens have a therapeutic effect on sleep disturbances associated with vasomotor symptoms offering superior benefits over placebo/control. It displays comparable benefits to oral combined hormone therapy for managing these disturbances according to network meta-analysis results.
- While specific information on adverse event-related discontinuation rates due to Duavee was not directly provided from the studies reviewed, certain medications including eszopiclone and oral combined hormone therapy were linked with higher adverse event-related discontinuation rates. This information is vital for evaluating tolerability and safety considerations.
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 |