title: The evolving role of oral hormonal therapies and review of conjugated estrogens/bazedoxifene for the management of menopausal symptoms.
abstract: This review describes the evolving role of oral hormone therapy (HT) for treating menopausal symptoms and preventing osteoporosis, focusing on conjugated estrogens/bazedoxifene (CE/BZA). Estrogens alleviate hot flushes and prevent bone loss associated with menopause. In nonhysterectomized women, a progestin should be added to estrogens to reduce the risk of endometrial cancer. Use of HT declined since the Women's Health Initiative (WHI) studies showed that HT does not prevent coronary heart disease (CHD) and that conjugated estrogens/medroxyprogesterone acetate increased the risk of invasive breast cancer after nearly 5 years of use. However, re-analyses of the WHI data suggest that some risks (eg, CHD, all-cause mortality) may be reduced when HT is initiated in women <60 years of age and <10 years since menopause, compared with later. CE/BZA is the first menopausal HT without a progestogen for nonhysterectomized women. Instead, BZA, a selective estrogen receptor modulator, in combination with CE, protects against estrogenic effects on uterine and breast tissue. Data from 5 large, randomized clinical trials show that CE/BZA reduces hot flush frequency/severity, prevents bone loss, reduces bone turnover, improves the vaginal maturation index and ease of lubrication, and improves some measures of sleep and menopause-specific quality of life. In studies of up to 2 years, there was no increase in endometrial hyperplasia, vaginal bleeding, breast density, or breast pain/tenderness compared with placebo. Venous thromboembolism and stroke are risks of all estrogen-based therapies. The choice of HT should be individualized, with consideration of the risk/benefit profile and tolerability of therapy, as well as patient preferences.
authors.affiliation: a Departments of Psychiatry and Internal Medicine , Weill Cornell Medical College , New York , NY , USA.
authors.forename: Sharon J
authors.initials: SJ
authors.lastname: Parish
authors.affiliation: b Pfizer Global Innovative Pharma , Pfizer Inc , Collegeville , PA , USA.
authors.forename: John A
authors.initials: JA
authors.lastname: Gillespie
mesh_terms: D000367:Age Factors; D016723:Bone Remodeling / Q000187:drug effects; D001943:Breast Neoplasms / Q000139:chemically induced; D002318:Cardiovascular Diseases / Q000139:chemically induced; D004333:Drug Administration Routes; D004338:Drug Combinations; D004714:Endometrial Hyperplasia / Q000139:chemically induced; D015914:Estrogen Replacement Therapy / Q000009:adverse effects / Q000379:methods*; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D019584:Hot Flashes / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008593:Menopause / Q000187:drug effects*; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D020845:Selective Estrogen Receptor Modulators / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000188:drug therapy; D013997:Time Factors; D014621:Vagina / Q000378:metabolism
chemical_list: D004338:Drug Combinations; D004966:Estrogens, Conjugated (USP); D007211:Indoles; D020845:Selective Estrogen Receptor Modulators; C447119:bazedoxifene
keywords: Conjugated estrogens/bazedoxifene; estrogens; hot flashes; menopause; osteoporosis; progestins; safety; tolerability