The tissue selective estrogen complex: a novel approach to the treatment of menopausal symptoms.

BACKGROUND: Menopause-related health issues, including vasomotor symptoms, vulvar/vaginal atrophy, and osteoporosis, can decrease women's quality of life. Hormone therapy is the primary treatment option targeting both menopausal symptoms and bone loss but has been associated with some safety concerns. The tissue selective estrogen complex (TSEC) is a novel therapy, partnering a selective estrogen receptor modulator (SERM) with one or more estrogens. The pairing of bazedoxifene (BZA) with conjugated estrogens (CE) has been evaluated in the Selective estrogens, Menopause, And Response to Therapy (SMART) phase 3 trials. This article reviews key findings for BZA/CE and discusses its potential as a treatment option for postmenopausal women.

METHODS: A review of BZA/CE findings from the SMART trials was conducted based on relevant publications and presentations.

RESULTS: BZA 20 mg/CE 0.45 and 0.625 mg have been shown to reduce hot flush frequency (by 74% and 80%, respectively, versus 51% for placebo [SMART-2 trial]) and severity, improve measures of vulvar/vaginal atrophy (SMART-3 trial), and prevent bone loss (mean percent change in lumbar spine bone mineral density [BMD] of 0.24 and 0.60, respectively, versus-1.28 for placebo [SMART-5 trial]) in postmenopausal women. These BZA/CE doses are associated with a favorable safety and tolerability profile, with high rates of cumulative amenorrhea and low incidences of breast pain. Overall, BZA/CE has been shown to be effective in relieving menopausal symptoms and preventing osteoporosis while maintaining endometrial and breast safety.

CONCLUSIONS: BZA/CE is a unique TSEC and a promising option for postmenopausal women seeking a safe and comprehensive therapy.