Preview

Problems of Endocrinology

Advanced search

The adherence of postmenopausal osteoporosis patients to therapy with combination medication contains alendronic acid and colecalciferol and its impact on the effectiveness of treatment

https://doi.org/10.14341/probl201460422-29

Abstract

Objectives. We examined the level of persistence (remaining on therapy) and compliance (taking the medication according to directions) and its impact on the effectiveness of therapy in patients with postmenopausal osteoporosis (PMO) treating with combination medication containing 70 mg alendronic acide and 2800 IU colecalciferol - Fosavance under the supervision of medical practitioners. Material and methods. The trial was performed in the form of 2-year prospective observational multicenter study that included 373 patients with PMO aged 40-88 years, initiated therapy with Fosavance under the supervision of 20 physicians had their medical practice in Moscow (18) or Moscow region (2). Patient compliance and persistence with therapy assessed every 6 months for 2 years, the effectiveness of treatment evaluated in 2 years on the dynamics of bone mineral density (BMD) and indicators of quality of life (QOL) by the SF-36 scale. Results. 70.2% of recruited in the study PMO patients prematurely stopped therapy with Fosavance, including 41% - in the first 6 months. Among the patients who dropped out, 42.7% were lost to follow by medical practitioners, 28.6% switched to another drug therapy, 19.1% had no money to buy medication. 22.5% from 111 women who continued treatment after 2 years were non-compliant due to the high cost of therapy (52%), optionality with the purchase of the drug at the pharmacy (28%) or taking pills (16%), or lack of medication in the pharmacy (4%). There were no statistically significant differences in BMD change in compliant (CP) and non-compliant patients (NCP) in lumbar spine, trochanter and total proximal femur in 2 years. But the increase in femoral neck BMD was higher in CP vs. NCP (Δ=1.97% [-1.41; 13.3] and Δ=-2.03 [-10.4 5.20], p=0.0267). CP had greater increase in QOL by SF-36 scoring at role-physical functioning (Δ=5 points [0; 25] at CP vs. Δ=0 points [-50; 0] at NCP, p=0.0195), role-emotional functioning (Δ=50 points [0; 84] and Δ=0 points [-100; 0] respectively, p=0.0001) and social functioning (Δ=13 points [-13; 25] and Δ=-13 points [-25; 0] respectively, p=0.0048). Conclusions. Low adherence to Fosavance negative impact on the effectiveness of treatment PMO and QOL. At the initiation of therapy it's requires close interaction between the doctor and the patient, maintaining patients on regular treatment motivation and selection of the drug taking into account convenience of the reception.

About the Authors

L A Marchenkova
M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow
Russian Federation


A V Dreval
M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow
Russian Federation


E A Prokhorova
M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow
Russian Federation


V A Loseva
M.F. Vladimirsky Moscow Regional Research Clinical Institute, Moscow
Russian Federation


References

1. Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY. European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 2013/01/01;24(1):23-57. doi: 10.1007/s00198-012-2074-y

2. Mихайлов Е.Е., Беневоленская Л.И. Эпидемиология остеопороза и переломов. / В кн.: «Руководство по остеопорозу». Под ред. Л.И.Беневоленской. – М.: БИНОМ. Лаборатория знаний. 2003. с. 10-55. [ Mikhaylov EE, Benevolenskaya LI. Epidemiologiya osteoporoza i perelomov. In book: «Rukovodstvo po osteoporozu» edited by L.I. Benevolenskaya. Moscow: BINOM. Laboratoriya znaniy; 2003. pp. 10-55.]

3. Михайлов Е.Е., Беневоленская Л.И., Баркова Т.В. Эпидемиологическая характеристика переломов конечностей в популяционной выборке лиц 50 лет и старше. // Остеопороз и остеопатии. 1998;(2):2-6. [Mikhaylov EE, Benevolenskaya LI, Barkova TV. Epidemiologicheskaya kharakteristika perelomov konechnostey v populyatsionnoy vyborke lits 50 let i starshe. Osteoporosis and osteopathy. 1998;(2):2-6.]

4. Kanis JA, Cooper C, Hiligsmann M, Rabenda V, Reginster JY, Rizzoli R. Partial adherence: a new perspective on health economic assessment in osteoporosis. Osteoporosis International. 2011;22(10):2565-2573. doi: 10.1007/s00198-011-1668-0.

5. Siris ES, Harris ST, Rosen CJ, Barr CE, Arvesen JN, Abbott TA, et al. Adherence to Bisphosphonate Therapy and Fracture Rates in Osteoporotic Women: Relationship to Vertebral and Nonvertebral Fractures From 2 US Claims Databases. Mayo Clin Proc. 2006;81(8):1013-22. doi: 10.4065/81.8.1013

6. Soong YK, Tsai KS, Huang HY, Yang RS, Chen JF, Wu PCH, et al. Risk of refracture associated with compliance and persistence with bisphosphonate therapy in Taiwan. Osteoporos Int. 2013;24(2):511-21. doi: 10.1007/s00198-012-1984-z

7. Black DM, Cummings SR, Karpf DB, Cauley JA, Thompson DE, Nevitt MC, et al. Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. The Lancet. 1996 Dec 7;348(9041):1535-41. doi: 10.1016/S0140-6736(96)07088-2

8. Справочник Видаль «Лекарственные препараты в России». [Handbook Vidal "Drugs in Russia".] Available at URL: http://www.vidal.ru/poisk_preparatov/fosavance.htm

9. Лесняк О.М., Евстигнеева Л.П., Коваль А.М., и др. Приверженность российских пациентов лечению остеопороза (национальный проект «Сила в постоянстве»). // Фарматека. 2008;157(3):73-9. [ Lesnyak OM, Evstigneeva LP, Koval' AM, et al. Priverzhennost' rossiyskikh patsientov lecheniyu osteoporoza (natsional'nyy proekt «Sila v postoyanstve»). Farmateka. 2008;157(3):73-9.]

10. Торопцова Н.В., Добровольская О.В., Никитинская О.А., Беневоленская Л.И. Частота антиостеопоротической терапии у пациентов с остеопорозом, осложненным переломами. Сборник тезисов IV Российского конгресса по остеопорозу. // Остеопороз и остеопатии. 2010;(1):114. [Toroptsova NV, Dobrovol'skaya OV, Nikitinskaya OA, Benevolenskaya LI. Chastota antiosteoporoticheskoy terapii u patsientov s osteoporozom, oslozhnennym perelomami. Sbornik tezisov IV Rossiyskogo kongressa po osteoporozu. Osteoporosis and osteopathy. 2010;(1):114.]

11. Васильева Н.В., Карманова В.Б., Мясоедова В.Б., Кожевникова Е.А. Приверженность пациентов с остеопорозом лечению и возможные пути ее повышения. Сборник тезисов IV Российского конгресса по остеопорозу. // Остеопороз и остеопатии. 2010;(1):114-115. [Vasil'eva NV, Karmanova VB, Myasoedova VB, Kozhevnikova EA. Priverzhennost' patsientov s osteoporozom lecheniyu i vozmozhnye puti ee povysheniya. Sbornik tezisov IV Rossiyskogo kongressa po osteoporozu. Osteoporosis and osteopathy. 2010;(1):114-115.]

12. Сафонова Ю.А., Зоткин Е.Г. Приверженность лечению пациентов с остеопорозом в реальной клинической практике. Сборник тезисов IV Российского конгресса по остеопорозу. // Остеопороз и остеопатии. 2010;(1):117. [ Safonova YuA, Zotkin EG. Priverzhennost' lecheniyu patsientov s osteoporozom v real'noy klinicheskoy praktike. Sbornik tezisov IV Rossiyskogo kongressa po osteoporozu. Osteoporosis and osteopathy. 2010;(1):117.]

13. Hansen C, Pedersen BD, Konradsen H, Abrahamsen B. Anti-osteoporotic therapy in Denmark predictors and demographics of poor refill compliance and poor persistence. Osteoporos Int. 2013;24(7):2079-2097. doi: 10.1007/s00198-012-2221-5.

14. Landfeldt E, Ström O, Robbins S, Borgström F. Adherence to treatment of primary osteoporosis and its association to fractures - the Swedish Adherence Register Analysis (SARA). Osteoporos Int. 2012;23(2):433–43. doi: 10.1007/s00198-011-1549-6.

15. Cooper A, Drake J, Brankin E; PERSIST Investigators. Treatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study. Int J Clin Pract. 2006;60(8):896-905. doi: 10.1111/j.1742-1241.2006.01059.x

16. Recker RR, Weinstein RS, Chesnut CH, Schimmer RC, Mahoney P, Hughes C, et al. Histomorphometric evaluation of daily and intermittent oral ibandronate in women with postmenopausal osteoporosis: results from the BONE study. Osteoporos Int. 2004;15(3):231-237. doi: 10.1007/s00198-003-1530-0.

17. Yood RA, Emani S, Reed JI, Lewis BE, Charpentier M, Lydick E. Compliance with pharmacologic therapy for osteoporosis. Osteoporos Int. 2003;14(12):965-968. doi: 10.1007/s00198-003-1502-4.

18. Kawate H, Ohnaka K, Adachi M, Kono S, Ikematsu H, Matsuo H, et al. Alendronate improves QOL of postmenopausal women with osteoporosis. Clin Interv Aging. 2010;2010(5):123–131. doi: 10.2147/CIA.S9696

19. Nevitt MC, Thompson DE, Black DM, Rubin SR, Ensrud K, Yates AJ, et al. Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Arch Intern Med. 2000;160(1):77-85. doi: 10.1001/archinte.160.1.77.

20. Kanis JA, Reginster JY, Kaufman JM, Ringe JD, Adachi JD, Hiligsmann M, et al. A reappraisal of generic bisphosphonates in osteoporosis. Osteoporos Int. 2012 2012/01/01;23(1):213-221. doi: 10.1007/s00198-011-1796-6

21. Grima DT, Papaioannou A, Airia P, Ioannidis G, Adachi JD. Adverse events, bone mineral density and discontinuation associated with generic alendronate among postmenopausal women previously tolerant of brand alendronate: a retrospective cohort study. BMC Musculoskelet Disord. 2010;11(1):68. doi: 10.1186/1471-2474-11-68.

22. Ström O, Landfeldt E. The association between automatic generic substitution and treatment persistence with oral bisphosphonates. Osteoporos Int. 2012;23(8):2201-2209. doi: 10.1007/s00198-011-1850-4.


Review

For citations:


Marchenkova L.A., Dreval A.V., Prokhorova E.A., Loseva V.A. The adherence of postmenopausal osteoporosis patients to therapy with combination medication contains alendronic acid and colecalciferol and its impact on the effectiveness of treatment. Problems of Endocrinology. 2014;60(4):22-29. (In Russ.) https://doi.org/10.14341/probl201460422-29

Views: 444


ISSN 0375-9660 (Print)
ISSN 2308-1430 (Online)