Comparing raloxifene with continuous combined estrogen-progestin therapy in postmenopausal women: Review of Euralox 1

Maturitas

Volumn 52, Issue 2, 2005, Pages 87-101

  Neven, Patrick ^a   Quail, Deborah ^b   Marin, Fernando ^b   Creatsas, George ^c   Depypere, Herman ^d   Rechberger, Tomasz ^e   Liu Léage, Soyi ^b   Pavo, Imre ^b   Schmitt, Henri ^b   Nickelsen, Thomas ^b  

^a Multidisciplinary Breast Center   (Belgium)

^b ELI LILLY AND COMPANY   (United States)

^c UNIVERSITY OF ATHENS   (Greece)

^d GHENT UNIVERSITY HOSPITAL   (Belgium)

^e University of Lublin   (Poland)

Author keywords

Benefits; Endometrium; Estrogen progestin therapy; Osteoporosis; Postmenopausal women; Prevention; Raloxifene; Risks

Indexed keywords

AMINO TERMINAL TELOPEPTIDE; BIOLOGICAL MARKER; CARBOXY TERMINAL TELOPEPTIDE; CONJUGATED ESTROGEN PLUS MEDROXYPROGESTERONE ACETATE; ESTRADIOL PLUS NORETHISTERONE ACETATE; FIBRINOGEN; HIGH DENSITY LIPOPROTEIN; KLIOFEM; LIPID; LOW DENSITY LIPOPROTEIN; PROGESTERONE; RALOXIFENE; TAMOXIFEN; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; BIOCHEMISTRY; BONE TURNOVER; BREAST CANCER; CARDIOVASCULAR RISK; CLINICAL TRIAL; CYST; DRUG SAFETY; DRUG TOLERABILITY; EMOTIONAL DISORDER; ENDOMETRIAL DISEASE; ENDOMETRIUM; ENDOMETRIUM POLYP; FIBRINOGEN BLOOD LEVEL; FLU LIKE SYNDROME; FRACTURE; GYNECOLOGY; HEADACHE; HORMONE SUBSTITUTION; HUMAN; ISCHEMIC HEART DISEASE; LEG CRAMP; LIPID BLOOD LEVEL; LONG TERM CARE; MASTALGIA; MENOPAUSAL SYNDROME; OSTEOPOROSIS; PATIENT COMPLIANCE; PATIENT SATISFACTION; POSTMENOPAUSE; QUALITY OF LIFE; REVIEW; RISK BENEFIT ANALYSIS; SELF REPORT; SIDE EFFECT; SPOTTING; STROKE; TREATMENT OUTCOME; URINE LEVEL; UTERINE CERVIX DISEASE; UTERUS; UTERUS BLEEDING; VAGINA BLEEDING; VAGINITIS; VASOMOTOR DISORDER; WEIGHT GAIN;

BONE REMODELING; DRUG COMBINATIONS; ENDOMETRIUM; ESTRADIOL; FEMALE; FIBRINOGEN; HUMANS; LIPIDS; MIDDLE AGED; MULTICENTER STUDIES; POSTMENOPAUSE; PROGESTINS; RALOXIFENE; RANDOMIZED CONTROLLED TRIALS; SELECTIVE ESTROGEN RECEPTOR MODULATORS;

EID: 25444470236     PISSN: 03785122     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.maturitas.2005.03.010     Document Type: Review

References (59)

1. T. Van Gorp, and P. Neven Endometrial safety of hormone replacement therapy: a review of literature Maturitas 42 2002 93 104
2. M. Wells, D.W. Sturdee, and D.H. Barlow Effect on endometrium of long term treatment with continuous combined oestrogen-progestogen replacement therapy: follow up study BMJ 325 2002 239 243
3. D. Grady, N.K. Wenger, and D. Herrington Postmenopausal hormone therapy increases risk for venous thromboembolic disease: the Heart and Estrogen/progestin Replacement Study Ann Intern Med 132 2000 689 696
4. J.E. Manson, J. Hsia, and K.C. Johnson Estrogen plus progestin and the risk of coronary heart disease N Engl J Med 349 2003 523 534
5. 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 288 2002 321 333
6. P.D. Delmas, N.H. Bjarnason, and B.H. Mitlak Effects of raloxifene on bone mineral density, serum cholesterol concentrations, and uterine endometrium in postmenopausal women N Engl J Med 337 1997 1641 1647
7. B. Ettinger, D.M. Black, and B.H. Mitlak Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. Results from a 3-year randomized clinical trial JAMA 282 1999 637 645
8. P. Delmas, K. Ensrud, and J.D. Adachi Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-year results from a randomized clinical trial J Clin Endocrinol Metab 87 2002 3609 3617
9. B.W. Walsh, L.H. Kuller, and R.A. Wild Effects of raloxifene on serum lipids and coagulation factors in healthy postmenopausal women JAMA 279 1998 1445 1454
10. V. Mijatovic, M.J. van der Mooren, P. Kenemans, G.W. de Valk-de Roo, and C. Netelenbos Raloxifene lowers serum lipoprotein(a) in healthy postmenopausal women: a randomized, double-blind, placebo-controlled comparison with conjugated equine estrogens Menopause 6 1999 134 137
11. G.A. Figtree, Y.Q. Lu, C.M. Webb, and P. Collins Raloxifene acutely relaxes coronary arteries in vitro by an estrogen receptor-dependent and nitric oxide-dependent mechanism Circulation 100 1999 1095 1101
12. N.H. Bjarnason, J. Haarbo, I. Byrjalsen, R.F. Kauffman, M.P. Knadler, and C. Christiansen Raloxifene reduces atherosclerosis: studies of optimized raloxifene doses in ovariectomized, cholesterol-fed rabbits Clin Endocrinol 52 2000 225 233
13. W.D. Zoma, R.S. Baker, and K.E. Clark Coronary and uterine responses to raloxifene in the sheep Am J Obstet Gynecol 182 2000 521 528
14. T.B. Clarkson, M.S. Anthony, and C.P. Jerome Lack of effect of raloxifene on coronary artery atherosclerosis of postmenopausal monkeys J Clin Endocrinol Metab 83 1998 721 726
15. E. Barrett-Connor, D. Grady, and A. Sashegyi Raloxifene and cardiovascular events in osteoporotic postmenopausal women. Four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial JAMA 287 2002 847 857
16. S.R. Cummings, S. Eckert, and K.A. Krueger The effect of raloxifene on risk of breast cancer in postmenopausal women: results from the MORE randomized trial JAMA 281 1999 2189 2197
17. J. Cauley, L. Norton, and M.E. Lippman Continued breast cancer risk reduction in postmenopausal women treated with raloxifene; 4-year results from the MORE trial Breast Cancer Res Treatm 65 2001 125 134
18. S.M. Boss, W.J. Huster, J.A. Neild, M.A. Glant, C.C. Eisenhut, and M.W. Draper Effects of raloxifene hydrochloride on the endometrium of postmenopausal women Am J Obstet Gynecol 177 1997 1458 1464
19. G.C. Davies, W.J. Huster, and W. Shen Endometrial response to raloxifene compared with placebo, cyclical hormone replacement therapy, and unopposed estrogen in postmenopausal women Menopause 6 1999 188 195
20. T. Nickelsen, G. Creatsas, and T. Rechberger Differential effects of raloxifene and continuous combined hormone replacement therapy on biochemical markers of cardiovascular risk: results from the Euralox 1 study Climacteric 4 2001 320 331
21. S. Voss, D. Quail, and A. Dawson A randomised, double-blind trial comparing raloxifene HCl and continuous combined hormone replacement therapy in postmenopausal women: effects on compliance and quality of life Br J Obstet Gynaecol 109 2002 874 885
22. P. Neven, T. Lunde, and P. Benedetti-Panici A multicentre randomised trial to compare uterine safety of raloxifene with a continuous combined hormone replacement therapy containing oestradiol and norethisterone acetate Br J Obstet Gynaecol 110 2003 157 167
23. P. Neven, D. Quail, and M. Lévrier Uterine effects of estrogen plus progestin therapy and raloxifene: adjudicated results from the Euralox study Obstet Gynecol 103 2004 881 891
24. F.J. Cohen, S. Watts, A. Shah, R. Akers, and L. Plouffe Uterine effects of 3-year raloxifene therapy in postmenopausal women younger than age 60 Obstet Gynecol 95 2000 104 110
25. E.E. Jolly, N.H. Bjarnason, and P. Neven Prevention of osteoporosis and uterine effects in postmenopausal women taking raloxifene for 5 years Menopause 10 2003 337 344
26. G. Christodoulacos, C. Panoulis, D. Botsis, D. Rizos, D. Kassanos, and G. Creatsas Transvaginal sonographic monitoring of the uterine effects of raloxifene and a continuous combined replacement therapy in postmenopausal women Maturitas 42 2002 77 84
27. G.L. Anderson, H.L. Judd, and A.M. Kaunitz Effects of estrogen plus progestin on gynaecologic cancers and associated diagnostic procedures JAMA 290 2003 1739 1748
28. P. Fugere, W.H. Scheele, A. Shah, T.R. Strack, M.D. Glant, and E. Jolly Uterine effects of raloxifene in comparison with continuous-combined hormone replacement therapy in postmenopausal women Am J Obstet Gynecol 182 2000 568 574
29. S. Goldstein, W. Scheele, and S. Rajagopalan A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium Obstet Gynecol 95 2000 95 103
30. S.L. Nand, M.A. Webster, R. Baber, V. O'Connor The Ogen/Provera Study Group Bleeding pattern and endometrial changes during continuous combined hormone replacement therapy Obstet Gynecol 91 1998 678 684
31. G. Giorda, D. Crivellari, and A. Veroneis Comparison of ultrasonography, hysteroscopy, and biopsy in the diagnosis of endometrial lesions in postmenopausal tamoxifen-treated patients Acta Obstet Gynecol Scand 81 2002 975 980
32. P.M. Fall, D. Kennedy, J.A. Smith, M.J. Seibel, and L.G. Raisz Comparison of serum and urine assays for biochemical markers of bone resorption in postmenopausal women with and without hormone replacement therapy and in men Osteoporosis Int 11 2000 481 485
33. E. Fink, C. Cormier, P. Steinmetz, C. Kindermans, Y. Le Bouc, and J.-C. Souberbielle Differences in the capacity of several biochemical bone markers to assess high bone turnover in early menopause and response to alendronate therapy Osteoporosis Int 11 2000 295 303
34. K. Kawana, M. Takahashi, H. Hoshino, and K. Kushida Comparison of serum and urinary C-terminal telopeptide of type I collagen in ageing, menopause and osteoporosis Clin Chim Acta 316 2002 109 115
35. J.K. Scariano, P.J. Garry, G.D. Montoya, J.M. Wilson, and R.H. Baumgartner Critical differences in the serial measurement of three biochemical markers of bone turnover in the sera of pre- and postmenopausal women Clin Biochem 34 2001 639 644
36. P.D. Delmas, P. Hardy, P. Garnero, and M. Dain Monitoring individual responses to hormone replacement therapy with bone markers Bone 26 2000 553 560
37. T. Nickelsen, T. Rechberger, D. Quail, A. Hottgenroth Pfützner for the Euralox Study Group Effects of raloxifene and continuous combined hormone replacement therapy on new biochemical serum markers of bone metabolism Proceedings of the Poster presented at 8th World Congress of the International Society of Gynecological Endocrinology Florence, Italy, 6-9 December 2000
38. K.M. Prestwood, M. Gunness, D.B. Muchmore, Y. Lu, M. Wong, and L.G. Raisz A comparison of the effects of raloxifene and estrogen on bone in postmenopausal women J Clin Endocrinol Metab 85 2000 2197 2202
39. K.S. Tsai, M.L. Yen, and H.A. Pan Raloxifene versus continuous combined estrogen/progestin therapy: densitometric and biochemical effects in healthy postmenopausal Taiwanese women Osteoposis Int 12 2001 1020 1025
40. F.H. Loh, L.H. Chen, S.L. Yu, and L.N. Jorgensen The efficacy of two dosages of a continuous combined hormone replacement regimen Maturitas 41 2002 123 131
41. C.C. Johnston, N.H. Bjarnason, and F.J. Cohen Long-term effects of raloxifene on bone mineral density, bone turnover, and serum lipid levels in early postmenopausal women: three-year data from 2 double-blind, randomized, placebo-controlled trials Arch Intern Med 160 2000 3444 3450
42. P.D. Delmas, H.K. Genant, and G.G. Crans Severity of prevalent vertebral fractures and the risk of subsequent vertebral and nonvertebral fractures: results from the MORE trial Bone 33 2003 522 532
43. E.G. Lufkin, H.W. Wahner, and W.M. O'Fallon Treatment of postmenopausal osteoporosis with transdermal estrogen Ann Intern Med 117 1992 1 9
44. Writing Group for the PEPI Trial Effects of hormone therapy on bone mineral density JAMA 276 1996 1389 1396
45. O. Johnell, W.H. Scheele, Y. Lu, J.-Y. Reginster, A.G. Need, and E. Seeman Additive effects of raloxifene and alendronate on bone density and biochemical markers of bone remodelling in postmenopausal women with osteoporosis J Clin Endocrinol Metab 87 2002 985 992
46. J.J. Stepan, D. Michalska, V. Zikan, and J. Vokrouhlicka Biochemical markers of type I collagen synthesis and degradation in monitoring osteoporosis treatment with ralozifene or alendronate J Bone Miner Res 17 Suppl. 2 2002 SA05
47. M.R. Rubin, K.H. Lee, D.J. McMahon, and S.J. Silverberg Raloxifene lowers serum calcium and markers of bone turnover in postmenopausal women with primary hyperparathyroidism J Clin Endocrinol Metab 88 2003 1174 1178
48. V. DeLeo, A. LaMarca, G. Morgante, D. Lanzetta, C. Setacci, and F. Petraglia Randomized control study of the effects of raloxifene on serum lipids and homocysteine in older women Am J Obstet Gynecol 184 2001 350 353
49. M. Seed, R.H. Sands, M. McLaren, G. Kirk, and D. Darko The effect of hormone replacement therapy and route of administration on selected cardiovascular risk factors in post-menopausal women Family Practice 17 2000 497 507
50. N.K. Wenger, E. Barrett-Connor, and P. Collins Baseline characteristics of participants in the Raloxifene Use for The Heart (RUTH) trial Am J Cardiol 90 2002 1204 1210
51. L. Mosca, E. Barrett-Connor, and N.K. Wenger Design and methods of the Raloxifene Use for The Heart (RUTH) study Am J Cardiol 88 2001 392 395
52. S. Hulley, D. Grady, and T. Bush Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women JAMA 280 1998 605 613
53. D. Grady, D. Herrington, and V. Bittner Cardiovascular disease outcomes during 6.8 years of hormone therapy. Heart and estrogen/progestin replacements study follow-up (HERS II) JAMA 288 2002 49 57
54. H.N. Hodis, W.J. Mack, and S.P. Azen Hormone therapy and the progression of coronary artery atherosclerosis in postmenopausal women N Engl J Med 349 2003 535 545
55. D.M. Herrington, D.M. Reboussin, and K.B. Brosnihan Effects of estrogen replacement on the progression of coronary artery atherosclerosis N Engl J Med 343 2000 522 529
56. T. Vihtamaki, R. Savilahti, and R. Tuimala Why do postmenopausal women discontinue hormone replacement therapy? Maturitas 33 1999 99 105
57. B.G. Wren, and L. Brown Compliance with hormonal replacement therapy Maturitas 13 1991 17 21
58. M. Hunter The Women's Health Questionnaire: a measure of mid-aged women's perceptions of their emotional and physical health Psychol Health 7 1992 45 54
59. E. Barrett-Connor, J.A. Cauley, A. Sashegyi, P.M. Kulkarni, D.A. Cox, and M.J. Geiger Risk-benefit assessment of raloxifene: influence of baseline cardiovascular risk J Bone Miner Res 19 2004 1270 1275