Future long-term trials of postmenopausal hormone replacement therapy what is possible and what is the optimal protocol and regimen?

Climacteric

Volumn 15, Issue 3, 2012, Pages 288-293

  Purbrick, B ^a   Stranks, K ^a   Sum, C ^a   MacLennan, A H ^a  

^a UNIVERSITY OF ADELAIDE   (Australia)

Author keywords

BAZEDOXIFENE; ELITE; FEASIBILITY; HORMONE REPLACEMENT THERAPY; KEEPS; LONG TERM RANDOMIZED CONTROLLED TRIALS; PROTOCOL; TRANSDERMAL ESTROGEN

Indexed keywords

BAZEDOXIFENE; ESTRADIOL; ESTROGEN; PROGESTERONE;

BREAST TENDERNESS; CLINICAL PRACTICE; CLINICAL PROTOCOL; ESTROGEN THERAPY; FEMALE; GENERAL PRACTICE; HUMAN; ISCHEMIC HEART DISEASE; LONG TERM CARE; MENOPAUSAL SYNDROME; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STROKE; THROMBOEMBOLISM; UTERUS BLEEDING;

ADMINISTRATION, CUTANEOUS; ESTROGEN REPLACEMENT THERAPY; ESTROGENS; FEMALE; HUMANS; INDOLES; MIDDLE AGED; PLACEBOS; POSTMENOPAUSE; PROGESTERONE; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SELECTIVE ESTROGEN RECEPTOR MODULATORS; WOMEN'S HEALTH;

EID: 84861357217     PISSN: 13697137     EISSN: 14730804     Source Type: Journal    
DOI: 10.3109/13697137.2011.635825     Document Type: Review

References (39)

1. MacLennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database of Systematic Reviews 2004, Issue 4. Art. No.: CD002978
2. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002;288:321-33 (Pubitemid 34761611)
3. Anderson GL, Limacher M, Assaf AR, et al . Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial. JAMA 2004;291:1701-12 (Pubitemid 38489892)
4. Vickers MR, MacLennan AH, Lawton B, et al. Main morbidities recorded in the Women's International Study of long Duration Oestrogen after Menopause (WISDOM): a randomised controlled trial of hormone replacement therapy in postmenopausal women. BMJ 2007;335:234-44
5. Welton AJ, Vickers MR, Kim J, et al. Health related quality of life after combined hormone replacement therapy: randomized controlled trial. BMJ 2008;337:a1190
6. Pal L, Hailpern SM. Cardio-deleterious implications of declining premenopausal ovarian reserve. Sexuality, Reprod Menopause 2009;17:S11-12
7. Sowers M, Randolph Jr J, Jannausch M, et al . Levels of sex steroid and cardiovascular disease measures in premenopausal and hormone-treated women at midlife. Implications for the timing hypothesis. Arch Intern Med 2008;168:2146-53
8. Whitmer RA, Quesenberry CP, Zhou J, Yaffe K. Timing of hormone therapy and dementia: the critical window theory revisited. Ann Neurol 2011;69:163-9
9. MacLennan AH, Sturdee D. The end of WISDOM. C limacteric 2002;5:313-16 (Pubitemid 36143348)
10. Harman SM, Brinton EA, Cedars M, et al . KEEPS: The Kronos Early Estrogen Prevention Study. Climacteric 2005;8:3-12 (Pubitemid 40675116)
11. Hodis HN for the ELITE study group. http://clinicaltrials.gov/ct2/show/ NCT00114517
12. Miller J, Chan BK, Nelson HD. Postmenopausal estrogen replacement and risk for venous thromboembolism. A systematic review and meta-analysis for the U.S. Preventive Services Task Force. Ann Intern Med 2002;136:680-90 (Pubitemid 34462681)
13. De Lignieres B, Basdevant A, Thomas G, et al. Biological effects of estradiol-17 beta in post-menopausal women: oral versus percutaneous administration. J Clin Endocrinol Metab 1986;62: 536-41 (Pubitemid 16138173)
14. Scarabin PY, Alhenc-Gelas M, Plu-Bureau G, Taisne P, Agher R, Aiach M. Effects of oral and transdermal estrogen/progesterone regimens on blood coagulation and fi brinolysis in postmenopausal women. A randomized controlled trial. Arterioscler Thromb Vasc Biol 1997;17:3071-8 (Pubitemid 28016061)
15. Alkjaersig N, Fletcher AP, de Ziegler D, Steingold KA, Meldrum DR, Judd HL. Blood coagulation in postmenopausal women given estrogen treatment: comparison of transdermal and oral administration. J Lab Clin Med 1988;111:224-8 (Pubitemid 18074327)
16. Canonico M, Oger E, Plu-Bureau G, et al . Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. Circulation 2007;115:840-5 (Pubitemid 46294724)
17. Renoux C, Dell' Aniello S, Suissa S. Hormone replacement therapy and the risk of venous thromboembolism: a population-based study. J Thromb Haemost 2010;8:979-86
18. Arana A, Varas C, Gonzalez-Perez A, Guiterrez L, Bjerrum L, Garcia Rodriguez LA. Hormone therapy and cerebrovascular events: a population-based nested case-control study. Menopause 2006;13:730-6 (Pubitemid 44435027)
19. Speroff L. Transdermal hormone therapy and the risk of stroke and venous thrombosis. Climacteric 2010;13:429-32
20. Crook D. The metabolic consequences of treating postmenopausal women with non-oral hormone replacement therapy. Br J Obstet Gynaecol 1997;104:4-14
21. Sitruk-Ware R. New progestogens: a review of their effects in perimenopausal and postmenopausal women. Drugs Ageing 2004;21:865-83 (Pubitemid 39487071)
22. Hermsmeyer RK, Thompson TL, Pohost GM, Kaski JC. Cardiovascular effects of medroxyprogesterone acetate and progesterone: a case of mistaken identity? Nat Clin Pract Cardiovasc Med 2008;5:387-95 (Pubitemid 351935572)
23. Ronkin S, Northington R, Baracat E, et al. Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women. Obstet Gynecol 2005;105: 1397-404 (Pubitemid 40734275)
24. Utian W, Yu H, Bobula J, Mirkin S, Olivier S, Pickar JH. Bazedoxifene/conjugated estrogens and quality of life in postmenopausal women. Maturitas 2009;20:329-35
25. MacLennan AH, Broadbent JL, Lester S, Moore V. Oral oestrogen and combined oestrogen/progestogen therapy versus placebo for hot flushes. Cochrane Database of Systematic Reviews (Online) 2004:CD002978
26. Stram DO, Liu Y, Henderson KD, et al . Age-specific effects of hormone therapy use on overall mortality and ischemic heart disease mortality among women in the California Teachers Study. Menopause 2011;18:253-61
27. Salpeter SR, Walsh JM, Greyber E, Salpeter EE. Coronary heart disease events associated with hormone therapy in younger and older women. J Gen Intern Med 2006;21:363-6
28. Salpeter SR, Walsh ME, Greyber E, Ormiston TM, Salpeter EE. Mortality associated with hormone therapy in younger and older women. J Gen Intern Med 2004;19:791-804 (Pubitemid 38951954)
29. Pines A. Vasomotor symptoms and cardiovascular disease risk. Climacteric 2011;14:535-6
30. Lee SW, Jo HH, Kim MR, Kwon DJ, You YO, Kim JH. Association between menopausal symptoms and metabolic syndrome in postmenopausal women. Arch Gynecol Obstet 2011 August 19. Epub ahead of print
31. Paine BJ, Stocks NP, MacLennan AH. Seminars may increase recruitment to randomised controlled trials: lessons learned from WISDOM. Trials 2008;9:5 doi:10,1186/1745-6215-9-5
32. Greene JG. Measuring the symptoms dimension of quality of life: general and menopause-specific scales and their subscale structure. In Schneider HPG, ed. Hormone Replacement Therapy and Quality of Life. Lancaster: Parthenon Publishing, 2002:35-43
33. O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as arisk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med 1999;340:14-22 (Pubitemid 29024679)
34. Shaw LJ, Raggi P, Schisterman E, Berman DS, Callister TQ. Prognostic value of cardiac risk factors and coronary artery calcium for all-cause mortality . Radiology 2003 ; 228 : 826-33 (Pubitemid 37025495)
35. Schneider HPG, MacLennan AH, Feeny D. Assessment of healthrelated quality of life in menopause and aging. Climacteric 2008; 11:93-107 (Pubitemid 351451111)
36. MacLennan AH, Henderson VW, Paine BJ, et al . Hormone therapy, timing of initiation, and cognition in women older than 60 years: the REMEMBER pilot study. Menopause 2006;13: 28-36
37. Barrett-Connor E, Grady D. Hormone replacement therapy, heart disease, and other considerations. Ann Rev Pub Health 1998;19: 55-72 (Pubitemid 28279924)
38. Raggi P, Callister TQ, Cooil B, et al . Identification of patients at increased risk of fi rst unheralded acute myocardial infarction by electron-beam computed tomography. Circulation 2000;101: 850-5 (Pubitemid 30117879)
39. Vickers MR, Martin J, Meade TW. The Women's International Study of long-Duration Oestrogen after Menopause (WISDOM): a randomised controlled trial. BMC Women's Health 2007; 7:2