title: Bazedoxifene/conjugated estrogens for menopausal symptom treatment and osteoporosis prevention.
abstract: Postmenopausal women with vasomotor and vaginal symptoms are commonly treated with estrogens or combined estrogen/progestin therapy (hormone therapy). However, hormone therapy is associated with some safety and tolerability concerns and its benefit/risk profile may vary for women based on their time since menopause. The tissue selective estrogen complex (TSEC) pairs a selective estrogen receptor modulator with one or more estrogens, with the goal of relieving menopausal symptoms and preserving bone mineral density without stimulating the breast or endometrium. Bazedoxifene/conjugated estrogens (BZA/CE) is the first TSEC in clinical development. BZA 20 mg/CE 0.45 and 0.625 mg have been shown in phase-3 clinical trials to significantly improve hot flushes and vulvar/vaginal atrophy measures in symptomatic postmenopausal women and to prevent bone loss in postmenopausal women at risk for osteoporosis while ensuring endometrial safety. These doses of BZA/CE have also demonstrated significant improvements in quality-of-life scores, sleep parameters, and treatment satisfaction compared with placebo. BZA 20 mg/CE 0.45 and 0.625 mg showed high cumulative rates of amenorrhea and low rates of breast pain, similar to those with placebo. The favorable treatment effects seen with BZA/CE were generally consistent in women < 5 or ≥ 5 years since menopause. Based on its demonstrated efficacy and safety in women both closer to or further from menopause, BZA/CE may be an appropriate alternative to hormone therapy for the treatment of menopausal symptoms and the prevention of osteoporosis.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Midlife Health, University of Virginia Health System, Charlottesville, VA 22908, USA.
authors.forename: J V
authors.initials: JV
authors.lastname: Pinkerton
authors.forename: J H
authors.initials: JH
authors.lastname: Pickar
authors.forename: J
authors.initials: J
authors.lastname: Racketa
authors.forename: S
authors.initials: S
authors.lastname: Mirkin
mesh_terms: D000328:Adult; D000368:Aged; D001284:Atrophy; D017326:Clinical Trials, Phase III as Topic; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000009:adverse effects; D008593:Menopause; D008875:Middle Aged; D010024:Osteoporosis / Q000517:prevention & control*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage*; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology; D014623:Vaginal Diseases / Q000188:drug therapy; D014844:Vulva / Q000473:pathology
chemical_list: D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene