Kosin Med J.  2017 Jun;32(1):5-16. 10.7180/kmj.2017.32.1.5.

An Overview of the Clinical Efficacy and Safety of Tissue Selective Estrogen Complex: From the Selective Estrogens, Menopause, and Response to Therapy (SMART) Trials

Affiliations
  • 1Department of Obstetrics and Gynecology, College of Medicine, Inje University, Haeundae Paik Hospital, Busan, Korea. wooki1974@empal.com

Abstract

Hormone therapy (HT) is the most effective treatment for menopausal symptoms, and reduces both spinal and non-spinal postmenopausal osteoporotic fractures. However, a Women's Health Initiative (WHI) trial revealed that progestin-containing HT is associated with higher incidences of breast cancer and coronary heart disease than those associated with placebo. Tissue selective estrogen complex (TSEC) is a novel progestin-free HT option composed of conjugated estrogens (CE) and a selective estrogen receptor modulator. CE at a dose of 0.45 mg combined with 20 mg of bazedoxifene was the first TSEC medication approved in the United States and Korea for women with moderate to severe menopause-related vasomotor symptoms (VMS) and for preventing postmenopausal osteoporosis. This review summarizes the clinical efficacy, safety, and tolerability of TSEC as obtained from the five SMART clinical trials.

Keyword

Efficacy; Hormone therapy; Safety; Tissue selective estrogen complex

MeSH Terms

Breast Neoplasms
Coronary Disease
Estrogens*
Estrogens, Conjugated (USP)
Female
Humans
Incidence
Korea
Menopause*
Osteoporosis, Postmenopausal
Osteoporotic Fractures
Selective Estrogen Receptor Modulators
Treatment Outcome*
United States
Women's Health
Estrogens
Estrogens, Conjugated (USP)
Selective Estrogen Receptor Modulators

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