Перспективы применения Деносумаба у больных с разными стадиями хронической болезни почек


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Аннотация

Дано патогенетическое обоснование применения препарата Деносумаб. Приведены результаты основных клинических исследований, проведенных к настоящему времени и характеризующих его эффективность и безопасность как у больных остеопорозом, так и в популяции пациентов с разной степенью снижения функции почек.

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Об авторах

Н. Михайлова

РМАПО

Email: nephrology@mail.ru
кандидат медицинских наук Москва

Список литературы

  1. Bekker P., Holloway D., Nakanishi A. et al. The effect of a single dose of osteoprotegerin in postmenopausal women // J. Bone Miner. Res. 2001; 16: 348-60.
  2. Bekker P., Holloway D., Rasmussen A. et al. A single-dose placebocontrolled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women // J. Bone Miner. Res. 2004; 19: 1059-66.
  3. Block G., Bone H., Fang L. et al. A Single-Dose Study of Denosumab in Patients With Various Degrees of Renal Impairment // J. Bone Miner. Res. 2012; 27 (7): 1471-9.
  4. Bone, H., Bolognese, M., Yuen, C. et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women // J. Clin. Endocrinol. Metab. 2008; 93: 2149-57.
  5. Boonen S., Adachi J., Man Z. et al. Treatment with Denosumab Reduces the Incidence of New Vertebral and Hip Fractures in Postmenopausal Women at High Risk // J. Clin. Endocrinol. Metab. -2011; 96 (6): 1727-36.
  6. Bonewald L. The amazing osteocyte // J. Bone Miner. Res. 2011; 26: 229-38.
  7. Boyle W., Simonet W., Lacey D. Osteoclast differentiation and activation // Nature. 2003; 423: 337-42.
  8. Brasier A., Nussbaum S. Hungry bone syndrome: clinical and biochemical predictors of its occurrence after parathyroid surgery // Am. J. Med. 1988; 84: 654-60.
  9. Brown J., Prince R., Deal C. et al. Comparison of the effect of denosumab and alendronate on BMD and biochemical markers of bone turnover in postmenopausal women with low bone mass: a randomized, blinded, phase 3 trial // J. Bone Miner. Res. 2009; 24: 153-61.
  10. Cummings S., San Martin J., McClung М. et al. Denosumab for prevention of fractures in postmenopausal women with osteoporosis // N. Engl. J. Med. -2009; 361: 756-65.
  11. Eghbali-Fatourechi G., Khosla S., Sanyal A. et al. Role of RANK ligand in mediating increased bone resorption in early postmenopausal women // J. Clin. Invest. 2003; 111: 1221-30.
  12. Egbuna O., Cheung A., Siddhanti S. et al. Treatment of Osteoporosis by RANKL Inhibition with Denosumab in Women at High Cardiovascular Risk and with Renal Impairment Does Not Accelerate Vascular Calcification // J. Am. Soc. Nephrol. 2010; 21 (10): 640.
  13. Eriksen, E. Cellular mechanisms of bone remodeling // Rev. Endocr. Metab. Disord. 2010; 11: 219-27.
  14. Gallagher J. Advances in bone biology and new treatments for bone loss // Maturitas. 2008; 60: 65-9.
  15. Hruska K., Mathew S., Lund R. et al. The pathogenesis of vascular calcification in the chronic kidney disease mineral bone disorder: the links between bone and the vasculature // Semin. Nephrol. 2009; 29: 156-65.
  16. http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyNewsletter/ UCM 168579.pdf.
  17. Jamal S., Ljunggren Ё., Stehman-Breen C. et al. Effects of Denosumab on Fracture and Bone Mineral Density by Level of Kidney Function // J. Bone Miner. Res. 2011; 26 (8): 1829-35.
  18. Jassal S., von Muhlen D., Barrett-Connor E. Measures of renal function, BMD, bone loss, and osteoporotic fracture in older adults: the Rancho Bernardo study // J. Bone Miner. Res. 2007; 22: 203-10.
  19. Jones C., McQuillan G., Kusek J. et al. Serum creatinine levels in the US population: third National Health and Nutrition Examination Survey // Am. J. Kidney Dis. 1998; 32: 992-9.
  20. Kendler D., Roux C., Benhamou, C. et al. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy // J. Bone Miner. Res. 2010; 25: 72-81.
  21. Kendler D., McClung M., Freemantle N. et al. Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate // Osteoporos Int. 2011; 22: 1725-35.
  22. Klawansky S., Komaroff E., Cavanaugh P. et al. Relationship between age, renal function and bone mineral density in the US population // Osteoporos. Int. -2003; 14: 570-6.
  23. Kong Y., Boyle W., Penninger J. Osteoprotegerin ligand: a common link between osteoclastogenesis, lymph node formation and lymphocyte development // Immunol. Cell. Biol. 1999; 77: 188-93.
  24. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification // Am. J. Kidney Dis. 2002; 39: 1-266.
  25. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD) // Kidney Int. 2009; 113: 1-130.
  26. Lewiecki E., Miller P., McClung M. et al. Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD // J. Bone Miner. Res. 2007; 22: 1832-41.
  27. Lipton A., Steger G., Figueroa J. et al. Randomized active-controlled phase II study of denosumab efficacy and safety in patients with breast cancer-related bone metastases // J. Clin. Oncol. 2007; 25: 4431-7.
  28. Looker A., Orwoll E., Johnston C. et al. Prevalence of low femoral bone density in older US adults from NHANES III // J. Bone Miner. Res. 1997; 12: 1769-71.
  29. McClung M., Lewiecki E., Bolognese M. et al. Effect of denosumab on bone mineral density and biochemical markers of bone turnover results of an 8 year phase 2 clinical trial // J. Bone Miner. Res. 2011; (Suppl. 1, ahead of print).
  30. Miller P., Bolognese M., Lewiecki E. et al. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after longterm continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial // Bone. 2008; 43: 222-9.
  31. Papapoulos S., Man Z., Mellstrom D. et al. Five-year denosumab treatment of postmenopausal women with osteoporosis: results from the first two years of the freedom trial extension // Osteoporosis Internat. 2001; 22 (1): 25.
  32. Padagas J., Colloton M., Shalhoub V. et al. The receptor activator of nuclear factor-kappaB ligand inhibitor osteoprotegerin is a bone-protective agent in a rat model of chronic renal insufficiency and hyperparathyroidism // Calcif. Tis. Int. -2006; 78: 35-44.
  33. Perazella M., Markowitz G. Bisphosphonate nephrotoxicity // Kidney Int. -2008; 74: 1385-93.
  34. Reid I., Miller P., Brown J. et al. Effects of denosumab on bone histomorphometry: the FREEDOM and STAND studies // J. Bone Miner. Res. -2010; 25: 2256-65.
  35. Schwarz E., Ritchlin C. Clinical development of anti-RANKL therapy // Arthritis Res. Ther. 2007; 9 (1): 7.
  36. Stopeck A., Lipton A., Body J. et al. Denosumab compared with zoledronic acid for the treatment of bone metastases in patients with advanced breast cancer: a randomized, double-blind study // J. Clin. Oncol. 2010; 28: 5132-9.
  37. Suda T., Takahashi N., Udagawa N. et al. Modulation of osteoclast differentiation and function by the new members of the tumor necrosis factor receptor and ligand families // Endocr. Rev. 1999; 20: 345-57.
  38. Wypych J., Li M., Guo A. et al. Human IgG2 antibodies display disulfide-mediated structural isoforms // J. Biol. Chem. 2008; 283: 16194-205.

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