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- Title
Gynecologic Safety of Conjugated Estrogens Plus Bazedoxifene: Pooled Analysis of Five Phase 3 Trials.
- Authors
Mirkin, Sebastian; Pinkerton, JoAnn V.; Kagan, Risa; Thompson, John R.; Pan, Kaijie; Pickar, James H.; Komm, Barry S.; Archer, David F.
- Abstract
Objective: To evaluate gynecologic safety of conjugated estrogens/bazedoxifene treatment for menopausal symptoms and osteoporosis prevention in nonhysterectomized women. Materials and Methods: We pooled data from five randomized, placebo-controlled trials of conjugated estrogens 0.625 mg/bazedoxifene 20 mg ( n = 1583), conjugated estrogens 0.45 mg/bazedoxifene 20 mg ( n = 1585), and placebo ( n = 1241). Gynecologic safety was evaluated by pelvic examination, Papanicolaou smear, endometrial biopsy, transvaginal ultrasound, mammogram, adverse events, and diary records of vaginal bleeding and breast pain/tenderness. Incidence rates and relative risks (RR) versus placebo were calculated with inverse variance weighting. Data for conjugated estrogens 0.45 mg/medroxyprogesterone acetate 1.5 mg, an active comparator in two trials ( n = 399), are included for comparison. Results: Endometrial hyperplasia occurred in <1% ( n = 4 [0.3%], 2 [0.2%], 1 [0.5%], and 2 [0.2%] for conjugated estrogens 0.625 mg/bazedoxifene 20 mg, conjugated estrogens 0.45 mg/bazedoxifene 20 mg, conjugated estrogens/medroxyprogesterone acetate, and placebo). There was one endometrial cancer, which occurred with conjugated estrogens 0.45 mg/bazedoxifene 20 mg (0.44/1000 woman-years [95% confidence interval (CI), 0.00-2.37]; RR versus placebo 0.91 [95% CI, 0.17-4.82]). There were seven cases of breast cancer: four with conjugated estrogens 0.45 mg/bazedoxifene 20 mg (1.00/1000 woman-years [95% CI, 0.00-3.21] RR 1.11 [95% CI, 0.33-3.78]), two with placebo, and one with conjugated estrogens/medroxyprogesterone acetate. Unlike conjugated estrogens/medroxyprogesterone acetate, conjugated estrogens/bazedoxifene did not increase breast density, breast pain/tenderness, or vaginal bleeding versus placebo. No active treatment increased ovarian cysts. Conclusion: Conjugated estrogens/bazedoxifene provides endometrial protection without increasing breast pain/density, vaginal bleeding, or ovarian cysts in nonhysterectomized postmenopausal women studied up to 2 years.
- Subjects
BREAST physiology; ESTROGEN replacement therapy; OSTEOPOROSIS prevention; SELECTIVE estrogen receptor modulators; BREAST tumors; COMBINATION drug therapy; CLINICAL trials; CONFIDENCE intervals; FISHER exact test; FEMALE reproductive organ diseases; MENOPAUSE; META-analysis; PATIENT safety; DATA analysis software; DESCRIPTIVE statistics; THERAPEUTICS
- Publication
Journal of Women's Health (15409996), 2016, Vol 25, Issue 5, p431
- ISSN
1540-9996
- Publication type
Article
- DOI
10.1089/jwh.2015.5351