Using bazedoxifene plus conjugated estrogens for treating postmenopausal women: A comprehensive review

Menopause

Volumn 19, Issue 4, 2012, Pages 479-485

  Taylor, Hugh S ^a   Ohleth, Kathleen ^b  

^a YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b Precise Publications LLC   (United States)

Author keywords

Bazedoxifene; Conjugated estrogens; Menopause; Tissue selective estrogen complex

Indexed keywords

BAZEDOXIFENE; CONJUGATED ESTROGEN; RALOXIFENE;

AMENORRHEA; ARTHRALGIA; ARTICLE; BACKACHE; BREAST TENDERNESS; CARDIOVASCULAR DISEASE; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; ENDOMETRIUM HYPERPLASIA; FEMALE; HEADACHE; HEART INFARCTION; HUMAN; INFECTION; LUNG EMBOLISM; MENOPAUSAL SYNDROME; OSTEOPOROSIS; PAIN; POSTMENOPAUSE; SIDE EFFECT; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TRIACYLGLYCEROL BLOOD LEVEL; VASODILATATION; VENOUS THROMBOEMBOLISM;

BONE AND BONES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; ESTROGENS, CONJUGATED (USP); FEMALE; HOT FLASHES; HUMANS; INDOLES; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; POSTMENOPAUSE; QUALITY OF LIFE; SELECTIVE ESTROGEN RECEPTOR MODULATORS; TREATMENT OUTCOME; WOMEN'S HEALTH;

EID: 84859429702     PISSN: 10723714     EISSN: 15300374     Source Type: Journal    
DOI: 10.1097/gme.0b013e31823dbbca     Document Type: Article

References (41)

1. Rödström K, Bengtsson C, Lissner L, Milsom I, Sundh V, Björkelund C. A longitudinal study of the treatment of hot flushes: the population study of women in Gothenburg during a quarter of a century. Menopause 2002; 9:156-161. (Pubitemid 34492323)
2. Feldman BM, Voda A, Gronseth E. The prevalence of hot flash and associated variables among perimenopausal women. Res Nurs Health 1985;8:261-268.
3. Versi E, Harvey MA, Cardozo L, Brincat M, Studd JW. Urogenital prolapse and atrophy at menopause: a prevalence study. Int Urogynecol J Pelvic Floor Dysfunct 2001;12:107-110. (Pubitemid 32451986)
4. Haines CJ, Xing SM, Park KH, Holinka CF, Ausmanas MK. Prevalence of menopausal symptoms in different ethnic groups of Asian women and responsiveness to therapy with three doses of conjugated estrogens/medroxyprogesterone acetate: the Pan-Asia menopause (PAM) study. Maturitas 2005;52:264-276. (Pubitemid 41562199)
5. Bjarnason NH, Alexandersen P, Christiansen C. Number of years since menopause: spontaneous bone loss is dependent but response to hormone replacement therapy is independent. Bone 2002;30:637-642. (Pubitemid 34270504)
6. Nilas L, Christiansen C. The pathophysiology of peri-and postmenopausal bone loss. Br J Obstet Gynaecol 1989;96:580-587. (Pubitemid 19146815)
7. Rolnick SJ, Kopher RA, DeFor TA, Kelley ME. Hormone use and patient concerns after the findings of the Women's Health Initiative. Menopause 2005;12:399-404. (Pubitemid 41098652)
8. Helenius IM, Korenstein D, Halm EA. Changing use of hormone therapy among minority women since the Women's Health Initiative. Menopause 2007;14:216-222. (Pubitemid 46673472)
9. Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. Principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-333.
10. Evista (raloxifene hydrochloride) Prescribing Information. Indianapolis, IN: Eli Lilly and Company, 2007.
11. Taylor HS. Designing the ideal selective estrogen receptor modulatorV an achievable goal? Menopause 2009;16:609-615.
12. Komm BS. A new approach to menopausal therapy: the tissue selective estrogen complex. Reprod Sci 2008;15:984-992.
13. Deroo BJ, Korach KS. Estrogen receptors and human disease. J Clin Invest 2006;116:561-570. (Pubitemid 43326860)
14. Komm BS, Kharode YP, Bodine PV, Harris HA, Miller CP, Lyttle CR. Bazedoxifene acetate: a selective estrogen receptor modulator with improved selectivity. Endocrinology 2005;146:3999-4008. (Pubitemid 41175771)
15. Komm BS, Lyttle CR. Developing a SERM: stringent preclinical selection criteria leading to an acceptable candidate (WAY-140424) for clinical evaluation. Ann N Y Acad Sci 2001;949:317-326. (Pubitemid 34059996)
16. Crabtree JS, Peano BJ, Zhang X, Komm BS, Winneker RC, Harris HA. Activity of three selective estrogen receptor modulators on hormonedependent responses in the mouse uterus and mammary gland. Mol Cell Endocrinol 2008;287:40-46.
17. Kharode Y, Bodine PVN, Miller CP, Lyttle CR, Komm BS. The pairing of a selective estrogen receptor modulator, bazedoxifene, with conjugated estrogens as a new paradigm for the treatment of menopausal symptoms and osteoporosis prevention. Endocrinology 2008;149:6084-6091.
18. Peano BJ, Crabtree JS, Komm BS, Winneker RC, Harris HA. Effects of various selective estrogen receptor modulators with or without conjugated estrogens on mouse mammary gland. Endocrinology 2009;150: 1897-1903.
19. Hall JM, McDonnell DP. Coregulators in nuclear estrogen receptor action: from concept to therapeutic targeting. Mol Interv 2005;5:343-357. (Pubitemid 43060715)
20. Berrodin TJ, Chang KC, Komm BS, Freedman LP, Nagpal S. Differential biochemical and cellular actions of Premarin estrogens: distinct pharmacology of bazedoxifene-conjugated estrogens combination. Mol Endocrinol 2009;23:74-85.
21. Pickar JH. Tissue selective estrogen complex: a new paradigm for menopausal therapy. Menopausal Med 2008;16:S10-S13.
22. Pickar JH, Yeh I-T, Bachmann G, Speroff L. Endometrial effects of a tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens as a menopausal therapy. Fertil Steril 2009;92: 1018-1024.
23. Lobo RA, Pinkerton JV, Gass MLS, et al. Evaluation of bazedoxifene/conjugated estrogens for the treatment of menopausal symptoms and effects on metabolic bone parameters and overall safety profile. Fertil Steril 2009;92:1025-1038.
24. Archer DF, Lewis V, Carr BR, Olivier S, Pickar JH. Bazedoxifene/ conjugated estrogens (BZA/CE): incidence of uterine bleeding in postmenopausal women. Fertil Steril 2009;92:1039-1044.
25. Lindsay R, Gallagher JC, Kagan R, Pickar JH, Constantine G. Efficacy of tissue-selective estrogen complex (TSEC) of bazedoxifene/conjugated estrogens (BZA/CE) for osteoporosis prevention in at-risk postmenopausal women. Fertil Steril 2009;92:1045-1052.
26. Pinkerton JV, Utian WH, Constantine GD, Olivier S, Pickar JH. Relief of vasomotor symptoms with the tissue selective estrogen complex (TSEC) containing bazedoxifene/conjugated estrogens: a randomized, controlled trial. Menopause 2009;16:1116-1124.
27. Kagan R, Williams RS, Pan K, Mirkin S, Pickar JH. A randomized, placebo-and active-controlled trial of bazedoxifene/conjugated estrogens (BZA/CE) for treatment of moderate to severe vulvar/vaginal atrophy in postmenopausal women. Menopause 2010;17:281-289.
28. Utian WH, Shoupe D, Bachmann G, Pinkerton JV, Pickar JH. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril 2001;75: 1065-1079. (Pubitemid 32522600)
29. Pickar JH, Yeh I, Wheeler JE, Cunnane MF, Speroff L. Endometrial effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril 2001;76:25-31. (Pubitemid 32600955)
30. Pickar JH, Yeh IT, Wheeler JE, Cunnane MF, Speroff L. Endometrial effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate: two-year substudy results. Fertil Steril 2003;80: 1234-1240. (Pubitemid 37377757)
31. Stovall DW, Utian W, Gass M, et al. The effects of combined raloxifene and oral estrogen on vasomotor symptoms and endometrial safety. Menopause 2007;14:510-517.
32. Davis SR, O'Neill SM, Eden J, et al. Transition from estrogen therapy to raloxifene in postmenopausal women: effects on treatment satisfaction and the endometriumVa pilot study. Menopause 2004;11:167-175. (Pubitemid 40353234)
33. Carranza-Lira S, Gooch AL, Saldivar N, Osterwalder MS. Climacteric symptom control after the addition of low-dose esterified conjugated estrogens to raloxifene standard doses. Int J Fertil Womens Med 2007;52: 93-96.
34. Wattanakumtornkul S, Chichareon S, Geater A, Suwan K. Compliance with hormone replacement therapy at Songklanagarind Hospital. J Obstet Gynaecol Res 2003;29:380-387. (Pubitemid 38180674)
35. Manonai J, Theppisai U, Suchartwatnachai C, Jetsawangsri T, Chittacharoen A. Compliance with hormone replacement therapy in Thai women. Maturitas 2003;44:201-205. (Pubitemid 36315816)
36. Shulman LP, Yankov V, Uhl K. Safety and efficacy of a continuous once-a-week 17A-estradiol/levonorgestrel transdermal system and its effects on vasomotor symptoms and endometrial safety in postmenopausal women: the results of two multicenter, double-blind, randomized, controlled trials. Menopause 2002;9:195-207. (Pubitemid 34492328)
37. Simon JA, Liu JH, Speroff L, Shumel BS, Symons JP. Reduced vaginal bleeding in postmenopausal women who receive combined norethindrone acetate and low-dose ethinyl estradiol therapy versus combined conjugated equine estrogens and medroxyprogesterone acetate therapy. Am J Obstet Gynecol 2003;188:92-99. (Pubitemid 36135603)
38. Barnabei VM, Cochrane BB, Aragaki AK, et al. Menopausal symptoms and treatment-related effects of estrogen and progestin in the Women's Health Initiative. Obstet Gynecol 2005;105:1063-1073. (Pubitemid 40571027)
39. Christodoulakos GE, Botsis DS, Lambrinoudaki IV, et al. A 5-year study on the effect of hormone therapy, tibolone and raloxifene on vaginal bleeding and endometrial thickness. Maturitas 2006;53:413-423.
40. Yildirim G, Tugrul S, Uslu H, Pekin O, Eren S. Effects of two different regimens of continuous hormone replacement therapy on endometrial histopathology and postmenopausal uterine bleeding. Arch Gynecol Obstet 2006;273:268-273. (Pubitemid 43221241)
41. Archer DF, Dorin M, Lewis V, Schneider DL, Pickar JH. Effects of lower doses of conjugated equine estrogens and medroxyprogesterone acetate on endometrial bleeding. Fertil Steril 2001;75:1080-1087. (Pubitemid 32522601)