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.

Links

Publisher Full Text

Authors

Pinkerton JV, Pickar JH, Racketa J, Mirkin S

Institution

Department of Obstetrics and Gynecology, Division of Midlife Health, University of Virginia Health System, Charlottesville, VA 22908, USA.

Source

Climacteric : the journal of the International Menopause Society 15:5 2012 Oct pg 411-8

MeSH

Adult
Aged
Atrophy
Clinical Trials, Phase III as Topic
Estrogens, Conjugated (USP)
Female
Hot Flashes
Humans
Indoles
Menopause
Middle Aged
Osteoporosis
Quality of Life
Randomized Controlled Trials as Topic
Selective Estrogen Receptor Modulators
Treatment Outcome
Vagina
Vaginal Diseases
Vulva

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

22853444