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Published in: BMC Women's Health 1/2008

Open Access 01-12-2008 | Research article

Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates

Authors: Shonda A Foster, Kathleen A Foley, Eric S Meadows, Joseph A Johnston, Sara Wang, Gerhardt M Pohl, Stacey R Long

Published in: BMC Women's Health | Issue 1/2008

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Abstract

Background

Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis.

Methods

This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan®). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate.

Results

Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model.

Conclusion

In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.
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Literature
1.
go back to reference U.S. Department of Health and Human Services: Bone Health and Osteoporosis: A Report of the Surgeon General. 2004, Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General U.S. Department of Health and Human Services: Bone Health and Osteoporosis: A Report of the Surgeon General. 2004, Rockville, MD: U.S. Department of Health and Human Services, Office of the Surgeon General
2.
go back to reference Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000, 17: 1-45. Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement. 2000, 17: 1-45.
3.
go back to reference Riggs BL, Melton LJ: The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995, 17: 505S-511S. 10.1016/8756-3282(95)00258-4.CrossRefPubMed Riggs BL, Melton LJ: The worldwide problem of osteoporosis: insights afforded by epidemiology. Bone. 1995, 17: 505S-511S. 10.1016/8756-3282(95)00258-4.CrossRefPubMed
4.
go back to reference Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Gluer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR, for the Multiple Outcomes of Raloxifene Evaluation Investigators: Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999, 282: 637-645. 10.1001/jama.282.7.637.CrossRefPubMed Ettinger B, Black DM, Mitlak BH, Knickerbocker RK, Nickelsen T, Genant HK, Christiansen C, Delmas PD, Zanchetta JR, Stakkestad J, Gluer CC, Krueger K, Cohen FJ, Eckert S, Ensrud KE, Avioli LV, Lips P, Cummings SR, for the Multiple Outcomes of Raloxifene Evaluation Investigators: Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA. 1999, 282: 637-645. 10.1001/jama.282.7.637.CrossRefPubMed
5.
go back to reference Delmas PD, Ensrud KE, Adachi JD, Harper KD, Sarkar S, Gennari C, Reginster J, Pols HA, Recker RR, Harris ST, Wu Wentao, Genant HK, Black DM, Eastell R: 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: 3609-3617. 10.1210/jc.87.8.3609.CrossRefPubMed Delmas PD, Ensrud KE, Adachi JD, Harper KD, Sarkar S, Gennari C, Reginster J, Pols HA, Recker RR, Harris ST, Wu Wentao, Genant HK, Black DM, Eastell R: 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: 3609-3617. 10.1210/jc.87.8.3609.CrossRefPubMed
6.
go back to reference Sambrook PN, Geusens P, Ribot C, Solimano JA, Ferrer-Barriendos J, Gaines K, Verbruggen N, Melton ME: Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (Efficacy of FOSAMAX® versus EVISTA® Comparison Trial) International. J Intern Med. 2004, 255: 503-511. 10.1111/j.1365-2796.2004.01317.x.CrossRefPubMed Sambrook PN, Geusens P, Ribot C, Solimano JA, Ferrer-Barriendos J, Gaines K, Verbruggen N, Melton ME: Alendronate produces greater effects than raloxifene on bone density and bone turnover in postmenopausal women with low bone density: results of EFFECT (Efficacy of FOSAMAX® versus EVISTA® Comparison Trial) International. J Intern Med. 2004, 255: 503-511. 10.1111/j.1365-2796.2004.01317.x.CrossRefPubMed
7.
go back to reference Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD, for the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group: Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA. 1999, 282: 1344-1352. 10.1001/jama.282.14.1344.CrossRefPubMed Harris ST, Watts NB, Genant HK, McKeever CD, Hangartner T, Keller M, Chesnut CH, Brown J, Eriksen EF, Hoseyni MS, Axelrod DW, Miller PD, for the Vertebral Efficacy with Risedronate Therapy (VERT) Study Group: Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis: a randomized controlled trial. JAMA. 1999, 282: 1344-1352. 10.1001/jama.282.14.1344.CrossRefPubMed
8.
go back to reference Lufkin EG, Wong M, Deal C: The role of selective estrogen receptor modulators in the prevention and treatment of osteoporosis. Rheum Dis Clin North Am. 2001, 27: 163-185. 10.1016/S0889-857X(05)70192-7.CrossRefPubMed Lufkin EG, Wong M, Deal C: The role of selective estrogen receptor modulators in the prevention and treatment of osteoporosis. Rheum Dis Clin North Am. 2001, 27: 163-185. 10.1016/S0889-857X(05)70192-7.CrossRefPubMed
9.
go back to reference Martino S, Cauley JA, Barrett-Connor E, Powles TJ, Mershon J, Disch D, Secrest RJ, Cummings SR, for the CORE investigators: Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst. 2004, 96: 1751-1761.CrossRefPubMed Martino S, Cauley JA, Barrett-Connor E, Powles TJ, Mershon J, Disch D, Secrest RJ, Cummings SR, for the CORE investigators: Continuing outcomes relevant to Evista: breast cancer incidence in postmenopausal osteoporotic women in a randomized trial of raloxifene. J Natl Cancer Inst. 2004, 96: 1751-1761.CrossRefPubMed
10.
go back to reference Martino S, Disch D, Dowsett SA, Keech CA, Mershon JL: Safety assessment of raloxifene over eight years in a clinical trial setting. Curr Med Res Opin. 2005, 21: 1441-1452. 10.1185/030079905X61839.CrossRefPubMed Martino S, Disch D, Dowsett SA, Keech CA, Mershon JL: Safety assessment of raloxifene over eight years in a clinical trial setting. Curr Med Res Opin. 2005, 21: 1441-1452. 10.1185/030079905X61839.CrossRefPubMed
11.
go back to reference Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER, Wade JL, Robidoux A, Margolese RG, James J, Lippman SM, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan C, Wolmark N, for the National Surgical Adjuvant Breast and Bowel Project (NSABP): Effects of tamoxifen vs. raloxifene on the risk of developing invasive breast cancer and other disease outcomes. The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006, 295: 2727-2741. 10.1001/jama.295.23.joc60074.CrossRefPubMed Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER, Wade JL, Robidoux A, Margolese RG, James J, Lippman SM, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan C, Wolmark N, for the National Surgical Adjuvant Breast and Bowel Project (NSABP): Effects of tamoxifen vs. raloxifene on the risk of developing invasive breast cancer and other disease outcomes. The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006, 295: 2727-2741. 10.1001/jama.295.23.joc60074.CrossRefPubMed
12.
go back to reference Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK: Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006, 355: 125-137. 10.1056/NEJMoa062462.CrossRefPubMed Barrett-Connor E, Mosca L, Collins P, Geiger MJ, Grady D, Kornitzer M, McNabb MA, Wenger NK: Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006, 355: 125-137. 10.1056/NEJMoa062462.CrossRefPubMed
13.
go back to reference Raloxifene (Evista) product label. 2007, Eli Lilly and Company, Indianapolis Raloxifene (Evista) product label. 2007, Eli Lilly and Company, Indianapolis
14.
go back to reference Kleerekoper M, Schein JR: Comparative safety of bone remodeling agents with a focus on osteoporosis therapy. J Clin Pharmacol. 2001, 41: 239-250. 10.1177/00912700122010050.CrossRefPubMed Kleerekoper M, Schein JR: Comparative safety of bone remodeling agents with a focus on osteoporosis therapy. J Clin Pharmacol. 2001, 41: 239-250. 10.1177/00912700122010050.CrossRefPubMed
15.
go back to reference Bamias A, Kastritis E, Bamia C, Moulopoulos LA, Melakopoulos I, Bozas G, Koutsoukou V, Gika D, Anagnostopoulos A, Papadimitriou C, Terpos E, Dimopoulos MA: Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors. J Clin Onco. 2005, 23: 8580-8587. 10.1200/JCO.2005.02.8670.CrossRef Bamias A, Kastritis E, Bamia C, Moulopoulos LA, Melakopoulos I, Bozas G, Koutsoukou V, Gika D, Anagnostopoulos A, Papadimitriou C, Terpos E, Dimopoulos MA: Osteonecrosis of the jaw in cancer after treatment with bisphosphonates: incidence and risk factors. J Clin Onco. 2005, 23: 8580-8587. 10.1200/JCO.2005.02.8670.CrossRef
16.
go back to reference Ibandronate (Boniva) product label. 2005, Roche GlaxoSmithKlein, Nutley, NJ Ibandronate (Boniva) product label. 2005, Roche GlaxoSmithKlein, Nutley, NJ
17.
go back to reference Alendronate (Fosamax) product label. 2005, Merck & Co, Inc., Whitehouse Station, NJ Alendronate (Fosamax) product label. 2005, Merck & Co, Inc., Whitehouse Station, NJ
18.
go back to reference Risedronate (Actonel) product label. 2005, Proctor & Gamble Pharmaceuticals, Cincinnati, OH 45202 Risedronate (Actonel) product label. 2005, Proctor & Gamble Pharmaceuticals, Cincinnati, OH 45202
20.
go back to reference Deyo RA, Cherkin DC, Ciol MA: Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992, 45: 613-19. 10.1016/0895-4356(92)90133-8.CrossRefPubMed Deyo RA, Cherkin DC, Ciol MA: Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992, 45: 613-19. 10.1016/0895-4356(92)90133-8.CrossRefPubMed
21.
go back to reference Cadarette SM, Katz JN, Brookhart A, Sturmer T, Stedman MR, Solomon DH: Relative effectiveness of osteoporosis drugs for preventing nonvertebral fractures. Ann Intern Med. 2008, 148: 637-46.CrossRefPubMedPubMedCentral Cadarette SM, Katz JN, Brookhart A, Sturmer T, Stedman MR, Solomon DH: Relative effectiveness of osteoporosis drugs for preventing nonvertebral fractures. Ann Intern Med. 2008, 148: 637-46.CrossRefPubMedPubMedCentral
22.
go back to reference Birnbaum HG, Cremieux PY, Greenberg PG, LeLorier J, Ostrander J, Venditti L: Using healthcare claims data for outcomes research and pharmacoeconomic analysis. Pharmacoeconomics. 1999, 16: 1-8. 10.2165/00019053-199916010-00001.CrossRefPubMed Birnbaum HG, Cremieux PY, Greenberg PG, LeLorier J, Ostrander J, Venditti L: Using healthcare claims data for outcomes research and pharmacoeconomic analysis. Pharmacoeconomics. 1999, 16: 1-8. 10.2165/00019053-199916010-00001.CrossRefPubMed
Metadata
Title
Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates
Authors
Shonda A Foster
Kathleen A Foley
Eric S Meadows
Joseph A Johnston
Sara Wang
Gerhardt M Pohl
Stacey R Long
Publication date
01-12-2008
Publisher
BioMed Central
Published in
BMC Women's Health / Issue 1/2008
Electronic ISSN: 1472-6874
DOI
https://doi.org/10.1186/1472-6874-8-24

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