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Published in: Archives of Osteoporosis 1/2017

Open Access 01-12-2017 | Original Article

Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study

Authors: A. Modi, P. R. Ebeling, M. S. Lee, Y. K. Min, A. Mithal, X. Yang, S. Baidya, S. Sen, S. Sajjan

Published in: Archives of Osteoporosis | Issue 1/2017

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Abstract

Summary

The purpose of this study was to describe the impact of gastrointestinal events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis. The results of this study show that gastrointestinal events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis.

Purpose

This study aimed to describe the impact of gastrointestinal (GI) events on patient-reported outcomes and health care resource use among Asia-Pacific women with postmenopausal osteoporosis.

Methods

The MUSIC OS-AP study included an observational cohort study of postmenopausal women with osteoporosis. Women were classified as untreated or treated, with treated patients further classified as new or experienced users. Adherence was measured by the Adherence Evaluation of Osteoporosis treatment (ADEOS) questionnaire, treatment satisfaction by the Osteoporosis Patient Satisfaction Questionnaire (OPSAT) while general health-related and osteoporosis-specific quality of life were measured by the European Quality of Life-5 Dimensions (EQ-5D) questionnaire and the Osteoporosis Assessment Questionnaire (OPAQ), respectively. The association of GI events with these outcomes was determined by covariate-adjusted regression analysis of least squares mean differences in the scores of treated patients with and without GI events. Resource utilization was measured as the number of physician visits over the past 3 months, and multivariate regression analysis was used to assess the association of GI events with the likelihood of a visit.

Results

The GI event profile, quality of life scores, and resource use were numerically similar in untreated and treated women. The rate of adherence among treated women was higher in experienced than in new users. As indicated by mean scores, experienced users had better quality of life and slightly higher treatment satisfaction and fewer physician visits than new users. Except for adherence in new users, all measures were similarly adversely affected by GI events in both new and experienced users.

Conclusions

GI events decreased adherence, treatment satisfaction, and quality of life in Asia-Pacific women with postmenopausal osteoporosis.
Literature
3.
go back to reference Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B (2003) Early discontinuation of treatment for osteoporosis. Am J Med 115:209–216CrossRefPubMed Tosteson AN, Grove MR, Hammond CS, Moncur MM, Ray GT, Hebert GM, Pressman AR, Ettinger B (2003) Early discontinuation of treatment for osteoporosis. Am J Med 115:209–216CrossRefPubMed
4.
go back to reference Ringe JD, Moller G (2009) Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int 30:213–221. doi:10.1007/s00296-009-0940-5 CrossRefPubMed Ringe JD, Moller G (2009) Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int 30:213–221. doi:10.​1007/​s00296-009-0940-5 CrossRefPubMed
5.
go back to reference Payer J, Cierny D, Killinger Z, Sulkova I, Behuliak M, Celec P (2009) Preferences of patients with post-menopausal osteoporosis treated with bisphosphonates—the VIVA II study. J Int Med Res 37:1225–1229CrossRefPubMed Payer J, Cierny D, Killinger Z, Sulkova I, Behuliak M, Celec P (2009) Preferences of patients with post-menopausal osteoporosis treated with bisphosphonates—the VIVA II study. J Int Med Res 37:1225–1229CrossRefPubMed
10.
go back to reference Modi A, Siris S, Yang X, Fan CP, Sajjan S (2015) Association between gastrointestinal events and persistence with osteoporosis therapy: analysis of administrative claims of a U.S. managed care population. J Manag Care Spec Pharm 21:499–506. doi:10.18553/jmcp.2015.21.6.499 Modi A, Siris S, Yang X, Fan CP, Sajjan S (2015) Association between gastrointestinal events and persistence with osteoporosis therapy: analysis of administrative claims of a U.S. managed care population. J Manag Care Spec Pharm 21:499–506. doi:10.​18553/​jmcp.​2015.​21.​6.​499
11.
go back to reference Yun H, Curtis JR, Guo L, Kilgore M, Muntner P, Saag K, Matthews R, Morrisey M, Wright NC, Becker DJ, Delzell E (2014) Patterns and predictors of osteoporosis medication discontinuation and switching among Medicare beneficiaries. BMC Musculoskelet Disord 15:112. doi:10.1186/1471-2474-15-112 CrossRefPubMedPubMedCentral Yun H, Curtis JR, Guo L, Kilgore M, Muntner P, Saag K, Matthews R, Morrisey M, Wright NC, Becker DJ, Delzell E (2014) Patterns and predictors of osteoporosis medication discontinuation and switching among Medicare beneficiaries. BMC Musculoskelet Disord 15:112. doi:10.​1186/​1471-2474-15-112 CrossRefPubMedPubMedCentral
12.
14.
go back to reference Turbi C, Herrero-Beaumont G, Acebes JC, Torrijos A, Grana J, Miguelez R, Sacristan J, Marin F (2004) Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: an open-label, prospective, nonrandomized, observational study. Clin Ther 26:245–256CrossRefPubMed Turbi C, Herrero-Beaumont G, Acebes JC, Torrijos A, Grana J, Miguelez R, Sacristan J, Marin F (2004) Compliance and satisfaction with raloxifene versus alendronate for the treatment of postmenopausal osteoporosis in clinical practice: an open-label, prospective, nonrandomized, observational study. Clin Ther 26:245–256CrossRefPubMed
15.
go back to reference Blumentals WA, Harris ST, Cole RE, Huang L, Silverman SL (2009) Risk of severe gastrointestinal events in women treated with monthly ibandronate or weekly alendronate and risedronate. Ann Pharmacother 43:577–585. doi:10.1345/aph.1L555 CrossRefPubMed Blumentals WA, Harris ST, Cole RE, Huang L, Silverman SL (2009) Risk of severe gastrointestinal events in women treated with monthly ibandronate or weekly alendronate and risedronate. Ann Pharmacother 43:577–585. doi:10.​1345/​aph.​1L555 CrossRefPubMed
16.
go back to reference Landfeldt E, Lang A, Robbins S, Strom O (2011) Gastrointestinal tolerability and patterns of switching in patients treated for primary osteoporosis: the Swedish adherence register analysis (SARA). Calcif Tissue Int 89:234–245. doi:10.1007/s00223-011-9511-3 CrossRefPubMed Landfeldt E, Lang A, Robbins S, Strom O (2011) Gastrointestinal tolerability and patterns of switching in patients treated for primary osteoporosis: the Swedish adherence register analysis (SARA). Calcif Tissue Int 89:234–245. doi:10.​1007/​s00223-011-9511-3 CrossRefPubMed
17.
go back to reference Modi A, Ebeling P, Lee MS, Min YK, Mithal A, Yang X, Sajjan S (2015) Medication use patterns, treatment satisfaction, and inadequate control of osteoporosis study in the Asia-Pacific region (MUSIC OS-AP): design of a multinational, prospective, observational study examining the impact of gastrointestinal events on osteoporosis management in postmenopausal women. Bone Rep 3:61–66. doi:10.1016/j.bonr.2015.09.002 CrossRefPubMedPubMedCentral Modi A, Ebeling P, Lee MS, Min YK, Mithal A, Yang X, Sajjan S (2015) Medication use patterns, treatment satisfaction, and inadequate control of osteoporosis study in the Asia-Pacific region (MUSIC OS-AP): design of a multinational, prospective, observational study examining the impact of gastrointestinal events on osteoporosis management in postmenopausal women. Bone Rep 3:61–66. doi:10.​1016/​j.​bonr.​2015.​09.​002 CrossRefPubMedPubMedCentral
18.
go back to reference Breuil V, Cortet B, Cotte FE, Arnould B, Dias-Barbosa C, Gaudin AF, Regnault A, Roborel de Climens A, Legrand E (2012) Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int 23:445–455. doi:10.1007/s00198-011-1555-8 CrossRefPubMed Breuil V, Cortet B, Cotte FE, Arnould B, Dias-Barbosa C, Gaudin AF, Regnault A, Roborel de Climens A, Legrand E (2012) Validation of the adherence evaluation of osteoporosis treatment (ADEOS) questionnaire for osteoporotic post-menopausal women. Osteoporos Int 23:445–455. doi:10.​1007/​s00198-011-1555-8 CrossRefPubMed
19.
go back to reference Flood EM, Beusterien KM, Green H, Shikiar R, Baran RW, Amonkar MM, Cella D (2006) Psychometric evaluation of the osteoporosis patient treatment satisfaction questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women. Health Qual Life Outcomes 4:42. doi:10.1186/1477-7525-4-42 CrossRefPubMedPubMedCentral Flood EM, Beusterien KM, Green H, Shikiar R, Baran RW, Amonkar MM, Cella D (2006) Psychometric evaluation of the osteoporosis patient treatment satisfaction questionnaire (OPSAT-Q), a novel measure to assess satisfaction with bisphosphonate treatment in postmenopausal women. Health Qual Life Outcomes 4:42. doi:10.​1186/​1477-7525-4-42 CrossRefPubMedPubMedCentral
20.
go back to reference Rabin R, de Charro F (2001) EQ-5D: a measure of health status from the EuroQol group. Ann Med 33:337–343CrossRefPubMed Rabin R, de Charro F (2001) EQ-5D: a measure of health status from the EuroQol group. Ann Med 33:337–343CrossRefPubMed
21.
go back to reference Walters SJ, Brazier JE (2005) Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 14:1523–1532CrossRefPubMed Walters SJ, Brazier JE (2005) Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Qual Life Res 14:1523–1532CrossRefPubMed
22.
go back to reference Sullivan PW, Lawrence WF, Ghushchyan V (2005) A national catalog of preference-based scores for chronic conditions in the United States. Med Care 43:736–749CrossRefPubMed Sullivan PW, Lawrence WF, Ghushchyan V (2005) A national catalog of preference-based scores for chronic conditions in the United States. Med Care 43:736–749CrossRefPubMed
23.
go back to reference Silverman S (2000) The osteoporosis assessment questionnaire (OPAQ): a reliable and valid disease-targeted measure of health-related quality of life (HRQOL) in osteoporosis. Qual Life Res 9:767–774. doi:10.1023/A:1008934208764 CrossRef Silverman S (2000) The osteoporosis assessment questionnaire (OPAQ): a reliable and valid disease-targeted measure of health-related quality of life (HRQOL) in osteoporosis. Qual Life Res 9:767–774. doi:10.​1023/​A:​1008934208764 CrossRef
24.
go back to reference Nixon A, Kerr C, Doll H, Naegeli AN, Shingler SL, Breheny K, Burge R, Gold DT, Silverman S (2014) Osteoporosis assessment questionnaire-physical function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function. Osteoporos Int 25:1775–1784. doi:10.1007/s00198-014-2695-4 CrossRefPubMedPubMedCentral Nixon A, Kerr C, Doll H, Naegeli AN, Shingler SL, Breheny K, Burge R, Gold DT, Silverman S (2014) Osteoporosis assessment questionnaire-physical function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function. Osteoporos Int 25:1775–1784. doi:10.​1007/​s00198-014-2695-4 CrossRefPubMedPubMedCentral
25.
go back to reference Kamatari M, Koto S, Ozawa N, Urao C, Suzuki Y, Akasaka E, Yanagimoto K, Sakota K (2007) Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate. J Bone Miner Metab 25:302–309. doi:10.1007/s00774-007-0768-6 CrossRefPubMed Kamatari M, Koto S, Ozawa N, Urao C, Suzuki Y, Akasaka E, Yanagimoto K, Sakota K (2007) Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate. J Bone Miner Metab 25:302–309. doi:10.​1007/​s00774-007-0768-6 CrossRefPubMed
26.
27.
go back to reference Modi A, Sen S, Adachi JD, Adami S, Cortet B, Cooper AL, Geusens P, Mellstrom D, Weaver J, van den Bergh JP, Nguyen AM, Sajjan S, Group M-OS (2016) Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study. Osteoporos Int 27:1227–1238. doi:10.1007/s00198-015-3388-3 CrossRefPubMed Modi A, Sen S, Adachi JD, Adami S, Cortet B, Cooper AL, Geusens P, Mellstrom D, Weaver J, van den Bergh JP, Nguyen AM, Sajjan S, Group M-OS (2016) Gastrointestinal symptoms and association with medication use patterns, adherence, treatment satisfaction, quality of life, and resource use in osteoporosis: baseline results of the MUSIC-OS study. Osteoporos Int 27:1227–1238. doi:10.​1007/​s00198-015-3388-3 CrossRefPubMed
28.
go back to reference Oh KW, Kim DY, Lee YS, Kang MI (2012) Osteoporosis patient treatment satisfaction questionnaire in postmenopausal women intermittently treated with oral bisphosphonates: the BRAVO study. J Bone Miner Metab 30:359–366. doi:10.1007/s00774-011-0326-0 CrossRefPubMed Oh KW, Kim DY, Lee YS, Kang MI (2012) Osteoporosis patient treatment satisfaction questionnaire in postmenopausal women intermittently treated with oral bisphosphonates: the BRAVO study. J Bone Miner Metab 30:359–366. doi:10.​1007/​s00774-011-0326-0 CrossRefPubMed
29.
go back to reference Chung YS, Lim SK, Chung HY, Lee IK, Park IH, Kim GS, Min YK, Kang MI, Chung DJ, Kim YK, Choi WH, Shong MH, Park JH, Byun DW, Yoon HK, Shin CS, Lee YS, Kwon NH (2009) Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women. Calcif Tissue Int 85:389–397. doi:10.1007/s00223-009-9294-y CrossRefPubMedPubMedCentral Chung YS, Lim SK, Chung HY, Lee IK, Park IH, Kim GS, Min YK, Kang MI, Chung DJ, Kim YK, Choi WH, Shong MH, Park JH, Byun DW, Yoon HK, Shin CS, Lee YS, Kwon NH (2009) Comparison of monthly ibandronate versus weekly risedronate in preference, convenience, and bone turnover markers in Korean postmenopausal osteoporotic women. Calcif Tissue Int 85:389–397. doi:10.​1007/​s00223-009-9294-y CrossRefPubMedPubMedCentral
30.
go back to reference Watts NB, Bilezikian JP, Camacho PM, Greenspan SL, Harris ST, Hodgson SF, Kleerekoper M, Luckey MM, McClung MR, Pollack RP, Petak SM (2010) American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract 16(Suppl 3):1–37CrossRefPubMedPubMedCentral Watts NB, Bilezikian JP, Camacho PM, Greenspan SL, Harris ST, Hodgson SF, Kleerekoper M, Luckey MM, McClung MR, Pollack RP, Petak SM (2010) American Association of Clinical Endocrinologists Medical Guidelines for clinical practice for the diagnosis and treatment of postmenopausal osteoporosis. Endocr Pract 16(Suppl 3):1–37CrossRefPubMedPubMedCentral
31.
go back to reference MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, Mojica W, Timmer M, Alexander A, McNamara M, Desai SB, Zhou A, Chen S, Carter J, Tringale C, Valentine D, Johnsen B, Grossman J (2008) Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 148:197–213CrossRefPubMed MacLean C, Newberry S, Maglione M, McMahon M, Ranganath V, Suttorp M, Mojica W, Timmer M, Alexander A, McNamara M, Desai SB, Zhou A, Chen S, Carter J, Tringale C, Valentine D, Johnsen B, Grossman J (2008) Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med 148:197–213CrossRefPubMed
32.
go back to reference Kanis JA, On behalf of the World Health Organization Scientific Group (2007) Assessment of osteoporosis at the primary health-care level. World Health Organization Collaborating Centre for metabolic bone diseases. University of Sheffield, United Kingdom Kanis JA, On behalf of the World Health Organization Scientific Group (2007) Assessment of osteoporosis at the primary health-care level. World Health Organization Collaborating Centre for metabolic bone diseases. University of Sheffield, United Kingdom
33.
go back to reference Chang FY, Chen PH, Wu TC, Pan WH, Chang HY, Wu SJ, Yeh NH, Tang RB, Wu L, James FE (2012) Prevalence of functional gastrointestinal disorders in Taiwan: questionnaire-based survey for adults based on the Rome III criteria. Asia Pac J Clin Nutr 21:594–600PubMed Chang FY, Chen PH, Wu TC, Pan WH, Chang HY, Wu SJ, Yeh NH, Tang RB, Wu L, James FE (2012) Prevalence of functional gastrointestinal disorders in Taiwan: questionnaire-based survey for adults based on the Rome III criteria. Asia Pac J Clin Nutr 21:594–600PubMed
36.
go back to reference Ghoshal UC, Singh R, Chang FY, Hou X, Wong BC, Kachintorn U, Functional Dyspepsia Consensus Team of the Asian N, Motility A, the Asian Pacific Association of G (2011) Epidemiology of uninvestigated and functional dyspepsia in Asia: facts and fiction. J Neurogastroenterol Motil 17:235–244. doi:10.5056/jnm.2011.17.3.235 CrossRefPubMedPubMedCentral Ghoshal UC, Singh R, Chang FY, Hou X, Wong BC, Kachintorn U, Functional Dyspepsia Consensus Team of the Asian N, Motility A, the Asian Pacific Association of G (2011) Epidemiology of uninvestigated and functional dyspepsia in Asia: facts and fiction. J Neurogastroenterol Motil 17:235–244. doi:10.​5056/​jnm.​2011.​17.​3.​235 CrossRefPubMedPubMedCentral
37.
go back to reference Clemens S, Begum N, Harper C, Whitty JA, Scuffham PA (2014) A comparison of EQ-5D-3L population norms in Queensland, Australia, estimated using utility value sets from Australia, the UK and USA. Qual Life Res 23:2375–2381. doi:10.1007/s11136-014-0676-x CrossRefPubMed Clemens S, Begum N, Harper C, Whitty JA, Scuffham PA (2014) A comparison of EQ-5D-3L population norms in Queensland, Australia, estimated using utility value sets from Australia, the UK and USA. Qual Life Res 23:2375–2381. doi:10.​1007/​s11136-014-0676-x CrossRefPubMed
38.
go back to reference Self-Reported Population Health: an international perspective based on EQ-5D (2014). 1 edn. Springer: Netherlands Self-Reported Population Health: an international perspective based on EQ-5D (2014). 1 edn. Springer: Netherlands
39.
go back to reference Yu ST, Chang HY, Yao KP, Lin YH, Hurng BS (2015) Validity of EQ-5D in general population of Taiwan: results of the 2009 National Health Interview and drug abuse survey of Taiwan. Qual Life Res 24:2541–2548. doi:10.1007/s11136-015-0978-7 CrossRefPubMed Yu ST, Chang HY, Yao KP, Lin YH, Hurng BS (2015) Validity of EQ-5D in general population of Taiwan: results of the 2009 National Health Interview and drug abuse survey of Taiwan. Qual Life Res 24:2541–2548. doi:10.​1007/​s11136-015-0978-7 CrossRefPubMed
Metadata
Title
Impact of gastrointestinal events on patient-reported outcomes in Asia-Pacific women with osteoporosis: baseline results of the MUSIC OS-AP study
Authors
A. Modi
P. R. Ebeling
M. S. Lee
Y. K. Min
A. Mithal
X. Yang
S. Baidya
S. Sen
S. Sajjan
Publication date
01-12-2017
Publisher
Springer London
Published in
Archives of Osteoporosis / Issue 1/2017
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI
https://doi.org/10.1007/s11657-017-0350-3

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