Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 0.45 mg conjugated estrogens and 20 mg bazedoxifene) |
Drug Class | Conjugated estrogens and estrogen agonist/antagonists |
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
- 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 all evaluated non-hormonal therapies, and there were no significant differences in VMS frequency reduction between fezolinetant 45 mg and any of the 27 hormonal therapy regimens studied.
- Bazedoxifene (BZA) 20 mg combined with conjugated estrogens (CE) significantly improved daily hot flushes, moderate/severe hot flushes, sleep disturbances, and total Menopause-Specific Quality of Life (MENQOL) compared to placebo, with BZA 20 mg/CE 0.625 mg being more effective than BZA 20 mg/CE 0.45 mg.
- The studies included women during or after the menopausal transition, with an average age of 61.24 years and a duration of menopausal symptoms of 90.83 weeks, making the findings particularly relevant for postmenopausal women experiencing these symptoms.
- Eszopiclone and oral combined hormone therapy had higher rates of adverse event-related discontinuation compared to placebo/control, indicating potential safety concerns associated with these treatments.
- Dropout rates were comparable between the interventions and placebo/control, suggesting similar tolerability across treatment options.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Duavee (conjugated estrogens/bazedoxifene) Prescribing Information. | 2024 | Pfizer Inc., New York, NY |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause | 2024 | Menopause (New York, N.Y.) |
Bazedoxifene plus conjugated estrogens improve menopausal symptoms in postmenopausal women: a systematic review and meta-analysis | 2022 | Gynecological Endocrinology : The Official Journal Of The International Society |
Pharmacologic and hormonal treatments for menopausal sleep disturbances: A network meta-analysis of 43 randomized controlled trials and 32,271 menopausal women | 2021 | Sleep Medicine Reviews |
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 |