Safety assessment of raloxifene over eight years in a clinical trial setting

References

• Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: Results from a 3-year randomized clinical trial. JAMA 1999;282:637–45
   PubMed Web of Science ®Google Scholar
• US prescribing information, Eli Lilly and Company, Indianapolis, IN, 2003
   Google Scholar
• Delmas PD, Ensrud KE, Adachi JD, et al. 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 2002;87:3609–17
   PubMed Web of Science ®Google Scholar
• Cummings SR, Eckert S, Krueger K, et al. The effect of raloxifene on risk of breast cancer in postmenopausal women. Results from the MORE randomized trial. JAMA 1999:281;2189–97. Erratum in: JAMA 1999;282: 2124
   Google Scholar
• Cauley J, Norton L, Lippman ME, et al. Continued Breast Cancer Risk Reduction in Postmenopausal Women Treated with Raloxifene: 4-year Results from the MORE Trial. Breast Cancer Res Treat 2001;65:125–34
   PubMed Web of Science ®Google Scholar
• Martino S, Cauley JA, Barrett-Connor E, et al. Invasive breast cancer risk reduction in postmenopausal women with osteoporosis treated with raloxifene for 8 years: Results from the Continuing Outcomes Relevant to Evista trial. J Natl Cancer Inst 2004;96: 1751–61
   Google Scholar
• Cohen FJ, Lu Y. Characterization of hot flashes reported by healthy postmenopausal women receiving raloxifene or placebo during osteoporosis prevention trials. Maturitas 2000;34:65–73
   PubMed Web of Science ®Google Scholar
• Jolly EE, Bjarnason NH, Neven P, et al. Prevention of osteoporosis and uterine effects in postmenopausal women taking raloxifene for 5 years. Menopause 2003;10:337–44
   PubMed Web of Science ®Google Scholar
• Lu Y, Cohen F, Lakshmanan M. Characterization of hot flashes during raloxifene therapy: analyses of adverse event reports from an integrated placebo-controlled clinical trial database. Menopause 1998;5: 282
   Google Scholar
• Grady D, Ettinger B, Moscarelli E, et al. Safety and Adverse Effects Associated with Raloxifene: Multiple Outcomes of Raloxifene Evaluation. Obstet Gynecol 2004;104:837–44
   PubMed Web of Science ®Google Scholar
• Cohen FJ, Watts S, Shah A, et al. Uterine effects of three-year raloxifene therapy in postmenopausal women younger than age 60. Obstet Gynecol 2000;95:104–10
   PubMed Web of Science ®Google Scholar
• Neven P, Goldstein SR, Ciaccia AV, et al. The effect of raloxifene on the incidence of ovarian cancer in postmenopausal women. Gynecol Oncol 2002;85:388–90
   PubMed Web of Science ®Google Scholar
• Yaffe K, Krueger K, Sarkar S, et al. Cognitive Function in Postmenopausal Women Treated with Raloxifene. N Engl J Med 2001;344:1207–13
   PubMed Web of Science ®Google Scholar
• Barrett-Connor E, Grady D, Sashegyi A, et al. Raloxifene and cardiovascular events in osteoporotic postmenopausal women: four-year results from the MORE (Multiple Outcomes of Raloxifene Evaluation) randomized trial. JAMA 2002;287:847–57
   Google Scholar
• International Conference on Harmonisation. International Conference on Harmonisation. 2004
   Google Scholar
• A multinational case-control study of cardiovascular disease and steroid hormone contraceptives. Description and validation of methods. World Health Organization Collaborative Study of Cardiovascular and Steroid Hormone Contraception. J Clin Epidemiol 1995;48:1513–47
   Google Scholar
• Carlin B, Gelfand A, Smith A. Hierarchical Bayesian analysis of change-point problems. J Roy Statistical Society, Series C 1992;41:389–405
   Web of Science ®Google Scholar
• Congdon P. Normal linear regression, general linear models and log-linear models. Bayesian statistical modeling. Wiley, 2001, pp. 118–21
   Google Scholar
• Barrett-Connor E, Cauley JA, Kulkarni PM, et al. Risk-Benefit Profile for Raloxifene: 4-Year Data From the Multiple Outcomes of Raloxifene Evaluation (MORE) Randomized Trial. J Bone Miner Res 2004;19: 1270–5
   Google Scholar
• Mosca L, Barrett-Connor E, Wenger NK, et al. Design and methods of the Raloxifene Use for The Heart (RUTH) study. Am J Cardiol 2001;88:392–5
   PubMed Web of Science ®Google Scholar
• Goldstein SR, Johnson S, Watts NB, et al. Incidence of urinary incontinence in postmenopausal women treated with raloxifene or estrogen. Menopause 2005;12:160–4
   PubMed Web of Science ®Google Scholar
• Jarkova NB, Martenyi F, Masanauskaite D, et al. Mood effect of raloxifene in postmenopausal women. Maturitas 2002;42:71–5
   PubMed Web of Science ®Google Scholar
• Nickelsen T, Lufkin EG, Riggs BL, et al. III. Raloxifene hydrochloride, a selective estrogen receptor modulator: safety assessment of effects on cognitive function and mood in postmenopausal women. Psychoneuroendocrinology 1999; 24:115–28
   Google Scholar
• Brown EG. Methods and pitfalls in searching drug safety databases utilising the Medical Dictionary for Regulatory Activities (MedDRA). Drug Safety 2003;26:145–58
   PubMed Web of Science ®Google Scholar