Adherence and persistence with osteoporosis treatments are essential for reducing fracture risk. Once-daily teriparatide is available in Japan for treating osteoporosis in patients with a high risk of fracture. The study objective was to describe real-world adherence and persistence with once-daily teriparatide 20？ g during the first year of treatment for patients who started treatment during the first eight months of availability in Japan. This prescription database study involved patients with an index date (first claim) between October 2010 and May 2011, a preindex period ≥6 months, and a postindex period ≥12 months and who were aged >45 years. Adherence (medication possession ratio (MPR)) and persistence (time from the start of treatment to discontinuation; a 60-day gap in supply) were calculated. A total of 287 patients started treatment during the specified time period; 123 (42.9%) were eligible for inclusion. Overall mean (standard deviation) adherence was 0.702 (0.366), with 61.0% of patients having high adherence (MPR > 0.8). The percentage of patients remaining on treatment was 65.9% at 180 days and 61.0% at 365 days. Our findings suggest that real-world adherence and persistence with once-daily teriparatide in Japan are similar to that with once-daily teriparatide in other countries and with other osteoporosis medications. 1. Introduction Osteoporosis is a very common disease in Japan that is associated with significant morbidity, mortality, and economic/social burdens [1–7]. Indeed, recent estimates from Japan suggest that 3.4%–12.4% of men and 16.3%–26.5% of women (mean (standard deviation) age: 69.9 (11.2) years) have lumbar, femoral neck, or hip osteoporosis [1]. If left untreated, osteoporosis can lead to osteoporotic fractures and increased mortality [2–5]. A number of factors increase the risk of subsequent fractures, including advanced age, low bone mineral density (BMD), previous vertebral fracture, and previous clinical fracture [8]. The number of osteoporotic fractures in Japan has increased during the last 20 years as the elderly population has increased in number [2, 3, 9]. As the size of the elderly population is expected to continue increasing in the future, the prevalence of osteoporosis in Japan will also increase [1]. Therefore, determining the most effective osteoporosis treatments is essential [1]. Long-term adherence and persistence with medications in the treatment of chronic conditions are crucial for preventing increases in morbidity, mortality, and healthcare costs [10]. In particular, long-term adherence and
References
[1]
N. Yoshimura, S. Muraki, H. Oka et al., “Prevalence of knee osteoarthritis, lumbar spondylosis, and osteoporosis in Japanese men and women: the research on osteoarthritis/osteoporosis against disability study,” Journal of Bone and Mineral Metabolism, vol. 27, no. 5, pp. 620–628, 2009.
[2]
H. Hagino, K. Furukawa, S. Fujiwara et al., “Recent trends in the incidence and lifetime risk of hip fracture in Tottori, Japan,” Osteoporosis International, vol. 20, no. 4, pp. 543–548, 2009.
[3]
H. Orimo, Y. Yaegashi, T. Onoda, Y. Fukushima, T. Hosoi, and K. Sakata, “Hip fracture incidence in Japan: estimates of new patients in 2007 and 20-year trends,” Archives of Osteoporosis, vol. 4, no. 1-2, pp. 71–77, 2009.
[4]
T. Suzuki and H. Yoshida, “Low bone mineral density at femoral neck is a predictor of increased mortality in elderly Japanese women,” Osteoporosis International, vol. 21, no. 1, pp. 71–79, 2010.
[5]
M. Shiraki, T. Kuroda, and S. Tanaka, “Established osteoporosis associated with high mortality after adjustment for age and co-mobidities in postmenopausal Japanese women,” Internal Medicine, vol. 50, no. 5, pp. 397–404, 2011.
[6]
N. Miyakoshi, E. Itoi, M. Kobayashi, and H. Kodama, “Impact of postural deformities and spinal mobility on quality of life in postmenopausal osteoporosis,” Osteoporosis International, vol. 14, no. 12, pp. 1007–1012, 2003.
[7]
N. Miyakoshi, M. Hongo, S. Maekawa, Y. Ishikawa, Y. Shimada, and E. Itoi, “Back extensor strength and lumbar spinal mobility are predictors of quality of life in patients with postmenopausal osteoporosis,” Osteoporosis International, vol. 18, no. 10, pp. 1397–1403, 2007.
[8]
S. Fujiwara, E. Hamaya, W. Goto et al., “Vertebral fracture status and the World Health Organization risk factors for predicting osteoporotic fracture risk in Japan,” Bone, vol. 49, no. 3, pp. 520–525, 2011.
[9]
T. Oinuma, M. Sakuma, and N. Endo, “Secular change of the incidence of four fracture types associated with senile osteoporosis in Sado, Japan: the results of a 3-year survey,” Journal of Bone and Mineral Metabolism, vol. 28, no. 1, pp. 55–59, 2010.
[10]
K. P. Krueger, B. A. Berger, and B. Felkey, “Medication adherence and persistence: a comprehensive review,” Advances in Therapy, vol. 22, no. 4, pp. 313–356, 2005.
[11]
J. A. Cramer, A. Roy, A. Burrell et al., “Medication compliance and persistence: terminology and definitions,” Value in Health, vol. 11, no. 1, pp. 44–47, 2008.
[12]
F. Lekkerkerker, J. A. Kanis, N. Alsayed et al., “Adherence to treatment of osteoporosis: a need for study,” Osteoporosis International, vol. 18, no. 10, pp. 1311–1317, 2007.
[13]
T. W. Downey, S. H. Foltz, S. J. Boccuzzi, M. A. Omar, and K. H. Kahler, “Adherence and persistence associated with the pharmacologic treatment of osteoporosis in a managed care setting,” Southern Medical Journal, vol. 99, no. 6, pp. 570–575, 2006.
[14]
D. T. Gold, I. M. Alexander, and M. P. Ettinger, “How can osteoporosis patients benefit more from their therapy? Adherence issues with bisphosphonate therapy,” Annals of Pharmacotherapy, vol. 40, no. 6, pp. 1143–1150, 2006.
[15]
J. J. Caro, K. J. Ishak, K. F. Huybrechts, G. Raggio, and C. Naujoks, “The impact of compliance with osteoporosis therapy on fracture rates in actual practice,” Osteoporosis International, vol. 15, no. 12, pp. 1003–1008, 2004.
[16]
E. S. Siris, S. T. Harris, C. J. Rosen et al., “Adherence to bisphosphonate therapy and fracture rates in osteoporotic women: relationship to vertebral and nonvertebral fractures from 2 US claims databases,” Mayo Clinic Proceedings, vol. 81, no. 8, pp. 1013–1022, 2006.
[17]
F.-E. Cotté, F. Mercier, and G. de Pouvourville, “Relationship between compliance and persistence with osteoporosis medications and fracture risk in primary health care in France: a retrospective case-control analysis,” Clinical Therapeutics, vol. 30, no. 12, pp. 2410–2422, 2008.
[18]
S. Yu, R. T. Burge, S. A. Foster, S. Gelwicks, and E. S. Meadows, “The impact of teriparatide adherence and persistence on fracture outcomes,” Osteoporosis International, vol. 23, no. 3, pp. 1103–1113, 2012.
[19]
M. Hiligsmann, A. Boonen, V. Rabenda, and J.-Y. Reginster, “The importance of integrating medication adherence into pharmacoeconomic analyses: the example of osteoporosis,” Expert Review of Pharmacoeconomics and Outcomes Research, vol. 12, no. 2, pp. 159–166, 2012.
[20]
J.-Y. Reginster, “Adherence and persistence: impact on outcomes and health care resources,” Bone, vol. 38, no. 2, supplement 2, pp. S18–S21, 2006.
[21]
D. H. Solomon, J. Avorn, J. N. Katz et al., “Compliance with osteoporosis medications,” Archives of Internal Medicine, vol. 165, no. 20, pp. 2414–2419, 2005.
[22]
J. Blouin, A. Dragomir, L.-G. Ste-Marie, J. C. Fernandes, and S. Perreault, “Discontinuation of antiresorptive therapies: a comparison between 1998–2001 and 2002–2004 among osteoporotic women,” Journal of Clinical Endocrinology and Metabolism, vol. 92, no. 3, pp. 887–894, 2007.
[23]
S. Silverman and D. T. Gold, “Compliance and persistence with osteoporosis medications: a critical review of the literature,” Reviews in Endocrine & Metabolic Disorders, vol. 11, no. 4, pp. 275–280, 2010.
[24]
E. Seeman, J. Compston, J. Adachi et al., “Non-compliance: the Achilles' heel of anti-fracture efficacy,” Osteoporosis International, vol. 18, no. 6, pp. 711–719, 2007.
[25]
P. Kothawala, E. Badamgarav, S. Ryu, R. M. Miller, and R. J. Halbert, “Systematic review and meta-analysis of real-world adherence to drug therapy for osteoporosis,” Mayo Clinic Proceedings, vol. 82, no. 12, pp. 1493–1501, 2007.
[26]
M. Kamatari, S. Koto, N. Ozawa et al., “Factors affecting long-term compliance of osteoporotic patients with bisphosphonate treatment and QOL assessment in actual practice: alendronate and risedronate,” Journal of Bone and Mineral Metabolism, vol. 25, no. 5, pp. 302–309, 2007.
[27]
I. Gorai, Y. Tanaka, S. Hattori, and Y. Iwaoki, “Assessment of adherence to treatment of postmenopausal osteoporosis with raloxifene and/or alfacalcidol in postmenopausal Japanese women,” Journal of Bone and Mineral Metabolism, vol. 28, no. 2, pp. 176–184, 2010.
[28]
M. Osaki, K. Tatsuki, T. Hashikawa et al., “Beneficial effect of risedronate for preventing recurrent hip fracture in the elderly Japanese women,” Osteoporosis International, vol. 23, no. 2, pp. 695–703, 2012.
[29]
“Forteo [package insert],” Eli Lilly Japan K.K., Kobe, Japan, 2011.
[30]
R. M. Neer, C. D. Arnaud, J. R. Zanchetta et al., “Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis,” The New England Journal of Medicine, vol. 344, no. 19, pp. 1434–1441, 2001.
[31]
B. L. Langdahl, G. Rajzbaum, F. Jakob et al., “Reduction in fracture rate and back pain and increased quality of life in postmenopausal women treated with teriparatide: 18-month data from the European Forsteo Observational Study (EFOS),” Calcified Tissue International, vol. 85, no. 6, pp. 484–493, 2009.
[32]
N. K. Arden, S. Earl, D. J. Fisher, C. Cooper, S. Carruthers, and M. Goater, “Persistence with teriparatide in patients with osteoporosis: the UK experience,” Osteoporosis International, vol. 17, no. 11, pp. 1626–1629, 2006.
[33]
K. Briot, P. Ravaud, P. Dargent-Molina, M. Zylberman, S. Liu-Leage, and C. Roux, “Persistence with teriparatide in postmenopausal osteoporosis; Impact of a patient education and follow-up program: the French experience,” Osteoporosis International, vol. 20, no. 4, pp. 625–630, 2009.
[34]
S. A. Foster, K. A. Foley, E. S. Meadows et al., “Adherence and persistence with teriparatide among patients with commercial, Medicare, and Medicaid insurance,” Osteoporosis International, vol. 22, no. 2, pp. 551–557, 2011.
[35]
V. Ziller, S. P. Zimmermann, M. Kalder et al., “Adherence and persistence in patients with severe osteoporosis treated with teriparatide,” Current Medical Research and Opinion, vol. 26, no. 3, pp. 675–681, 2010.
[36]
M. Mulgund, K. A. Beattie, A. K. Wong, A. Papaioannou, and J. D. Adachi, “Assessing adherence to teriparatide therapy, causes of nonadherence and effect of adherence on bone mineral density measurements in osteoporotic patients at high risk for fracture,” Therapeutic Advances in Musculoskeletal Disease, vol. 1, no. 1, pp. 5–11, 2009.
[37]
R. S. Weinstein, “Glucocorticoid-induced osteoporosis and osteonecrosis,” Endocrinology and Metabolism Clinics of North America, vol. 41, no. 3, pp. 595–611, 2012.
[38]
J. D. Adachi, D. A. Hanley, J. K. Lorraine, and M. Yu, “Assessing compliance, acceptance, and tolerability of teriparatide in patients with osteoporosis who fractured while on antiresorptive treatment or were intolerant to previous antiresorptive treatment: an 18-month, multicenter, open-label, prospective study,” Clinical Therapeutics, vol. 29, no. 9, pp. 2055–2067, 2007.
[39]
J. A. Cramer, M. M. Amonkar, A. Hebborn, and R. Altman, “Compliance and persistence with bisphosphonate dosing regimens among women with postmenopausal osteoporosis,” Current Medical Research and Opinion, vol. 21, no. 9, pp. 1453–1460, 2005.
[40]
D. Weycker, D. Macarios, J. Edelsberg, and G. Oster, “Compliance with drug therapy for postmenopausal osteoporosis,” Osteoporosis International, vol. 17, no. 11, pp. 1645–1652, 2006.
