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Arthralgia and Myalgia Associated with the Use of Bisphosphonate: An Active Monitoring Study

비스포스포네이트 제제 관련 관절통 및 근육통에 대한 지역 약국 약사 및 환자 능동적 모니터링

  • Song, Jung-woo (School of Pharmacy, Sungkyunkwan University) ;
  • Park, So-Hee (School of Pharmacy, Sungkyunkwan University) ;
  • Yoon, Dongwon (School of Pharmacy, Sungkyunkwan University) ;
  • Lee, Mo-Se (Regional Pharmacovigilance Center, Korean Pharmaceutical Association) ;
  • Lee, Jung-Min (Regional Pharmacovigilance Center, Korean Pharmaceutical Association) ;
  • Kim, Na-Young (Regional Pharmacovigilance Center, Korean Pharmaceutical Association) ;
  • Kim, Young-Wook (Regional Pharmacovigilance Center, Korean Pharmaceutical Association) ;
  • Lee, Ju-Yeun (College of Pharmacy, Seoul National University) ;
  • Shin, Ju-Young (School of Pharmacy, Sungkyunkwan University)
  • 송정우 (성균관대학교 약학대학) ;
  • 박소희 (성균관대학교 약학대학) ;
  • 윤동원 (성균관대학교 약학대학) ;
  • 이모세 (대한약사회 지역의약품안전센터) ;
  • 이정민 (대한약사회 지역의약품안전센터) ;
  • 김나영 (대한약사회 지역의약품안전센터) ;
  • 김영욱 (대한약사회 지역의약품안전센터) ;
  • 이주연 (서울대학교 약학대학) ;
  • 신주영 (성균관대학교 약학대학)
  • Received : 2021.03.23
  • Accepted : 2021.07.01
  • Published : 2021.09.30

Abstract

Objective: We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient. Methods: The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined. Results: A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98). Conclusion: Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.

Keywords

References

  1. Asan Medical Center. Disease information - osteoporosis. Available from http://www.amc.seoul.kr/asan/healthinfo/disease/diseaseDetail.do?contentId=31611. Accessed January 20, 2021.
  2. Lee JS, Jang SO. A study on reference values and prevalence of osteoporosis in Korea: the Korea national health and nutrition examination survey 2008-2011. J Korean Off Stat 2013;18(2):42-65.
  3. Healthcare Bigdata Hub. Statistics of national disease - osteoporosis. Available from http://opendata.hira.or.kr/op/opc/olapMfrnIntrsIlnsInfo.do. Accessed January 20, 2021.
  4. Chun SW. Pharmacological treatment of osteoporosis. J Korean Med Assoc 2019;62(10):542-50. https://doi.org/10.5124/jkma.2019.62.10.542
  5. Ganesan K, Bansal P, Goyal A, Roane D. Bisphosphonate. Available from https://www.ncbi.nlm.nih.gov/books/NBK470248/#article18343.s9. Accessed February 08, 2020.
  6. Choi HJ. Treatment for osteoporosis: focusing for bisphosphonate therapy. Korean J Fam Pract 2013;3(1):16-24.
  7. Wysowski DK, Chang JT. Alendronate and risedronate: reports of severe bone, joint, and muscle pain. Arch Intern Med 2005;165(3):346-7. https://doi.org/10.1001/archinte.165.3.350
  8. FDA alert. Severe musculoskeletal pain a risk with bisphosphonates. Available from https://www.healio.com/endocrinology/bone-mineralmetabolism/news/print/endocrine-today/%7Bfafc5981-b3e5-4307-9ad8-2a192a433bbd%7D/fda-alert-severe-musculoskeletal-pain-arisk-with-bisphosphonates. Accessed November 5, 2019.
  9. Thiebaud D, Sauty A, Burckhardt P, et al. An in vitro and in vivo study of cytokines in the acute-phase response associated with bisphosphonates. Calcif Tissue Int 1997;61(1):386-92. https://doi.org/10.1007/s002239900353
  10. Ugurlar M. Alendronate- and risedronate-induced acute polyarthritis. Osteoporos Int 2016;27(1):3383-5. https://doi.org/10.1007/s00198-016-3695-3
  11. Kang MK, Yoon NK. A study of adverse drug event reporting systems in Korea. Korean J Community Pharm. 2019;5(1):56-65.
  12. Patient Safety Drug Management Division, Korean Pharmaceutical Association. Regional drug safety center information. Available from https://www.safepharm.or.kr/sub_2_1.do. Accessed May 10, 2021.
  13. Korea Institute of Drug Safety and Risk Management. Regional drug safety center information and history. Available from https://www.drugsafe.or.kr/iwt/ds/ko/community/EgovCenterGuide.do Accessed January 20, 2021.
  14. Jin XM, Kim YJ, Yang BR, Choi NK, Park BJ. The role of consumers in the spontaneous adverse drug events reporting. J Pharmacoepidemiol Risk Manag 2010;3(3):101-12.
  15. Kang DY. The active pharmacovigilance system: a postscript of visiting the harvard pilgrim health care institute. J Pharmacoepidemiol Risk Manag 2017;9:45-7.
  16. Gordis L. Epidemiology, 5th Ed. Philadelphia: Elsevier, 2014: 198-199.
  17. Mor A, H.Pillinger M, L.Wortmann R, J.Mitnick H. Drug-induced arthritic and connective tissue disorders. Semin Arthritis Rheum 2008;38(3):249-64. https://doi.org/10.1016/j.semarthrit.2007.10.001
  18. Adwan MH. An update on drug-induced arthritis. Rheumatology International. 2016;36(1):1089-97. https://doi.org/10.1007/s00296-016-3462-y
  19. Bannwarth B. Drug-Induced Musculoskeletal Disorders. Drug Saf 2007;30(1):27-46. https://doi.org/10.2165/00002018-200730010-00004
  20. Lewiecki EM. Bisphosphonates for the treatment of osteoporosis: insights for clinicians. Ther Adv Chronic Dis 2010;1(3):115-28. https://doi.org/10.1177/2040622310374783
  21. Lee J, Lee EH, Jung JW, Kang HR, Cho SH. Public awareness of adverse drug reactions and pharmacovigilance system in Korea. J Pharmacoepidemiol Risk Manag 2012;5(2):68-77.
  22. Korean Medical Library Engine. Alendronate. Available from http://www.kmle.co.kr. Accessed February 26, 2021.
  23. Ministry of Food and Drug Safety. Change order for drug permission (bisphosphonate). Available from https://nedrug.mfds.go.kr/bbs/58/2182/. Accessed February 08, 2021.
  24. Bock O, Boerst H, Thomasius FE, et al. Common musculoskeletal adverse effects of oral treatment with once weekly alendronate and risedronate in patients with osteoporosis and ways for their prevention. J Musculoskelet Neuronal Interact 2007;7(2):144-8.
  25. Kim JA, Yoon S, Kim LY, Kim DS. Towards Actualizing the Value Potential of Korea Health Insurance Review and Assessment (HIRA) Data as a Resource for Health Research: Strengths, Limitations, Applications, and Strategies for Optimal Use of HIRA Data. J Korean Med Sci 2017;32(5):718-728. https://doi.org/10.3346/jkms.2017.32.5.718
  26. Kim SH, Kim H. Pictogram design for the assessment of pediatric pain. Journal of Integrated Design Research 2019;18(4):115-29.
  27. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Saf 2006;29(5):385-96. https://doi.org/10.2165/00002018-200629050-00003
  28. Rothman ML, Beltran P, Cappelleri JC, Lipscomb J, Teschendorf B. Patient-reported outcomes: conceptual issues. Value Health 2007;10(Suppl 2):S66-75. https://doi.org/10.1111/j.1524-4733.2007.00269.x
  29. Schmier JK, Halpern MT. Patient recall and recall bias of health state and health status. Expert Rev Pharmacoecon Outcomes Res 2004;4(2):159-63. https://doi.org/10.1586/14737167.4.2.159