Keywords
Osteoporosis
Teriparatide
Human Parathyroid Hormone
Teriparatide
Human Parathyroid Hormone
How to Cite
Louvison, M. C. P., Bersusa, A. A. S., Psaltikidis, E. M., & Nascimento, A. (2013). Teriparatide for the treatment of osteoporosis in postmenopausal women assisted by the Brazilian Public Health System. Boletim Do Instituto De Saúde - BIS, 14(2), 195–203. Retrieved from https://periodicos.saude.sp.gov.br/bis/article/view/34133
Abstract
Osteoporosis is a systemic disease characterized by low bone mass and micro-architectural deterioration of bone tissue, which increases the risk of bone fractures. There is a vast therapeutic arsenal for its treatment. However, in the State of São Paulo there are lawsuits to obtain the teriparatide. The drug stimulates the formation of new bone tissue and is not selected by use in the Brazilian Public Health System (SUS). A systematic review was conducted aiming to contribute to the rational use of teriparatide, and included studies published from 2008, in postmenopausal women with osteoporosis, considering fractures and bone mineral density (BMD) as outcomes. Evidence indicates superior efficacy of teriparatide compared to sodium alendronate, considering the reduction of fractures only in postmenopausal patients with severe osteoporosis and previous fractures. For women at different degrees of osteoporosis, however, there is evidence of better results as teriparatide only for BMD, as compared to sodium alendronate or placebo. Teriparatide should be recommended as an alternative to bisphosphonates only for postmenopausal women with severe osteoporosis, osteoporotic fractures or post-treatment failure with conventional, for a maximum period of 2 years.
References
1. AETNA. Teriparatide (Forteo). Clin Policy Bull [periódico na internet]. 2011. [acesso em 15 dez 2011] Disponível em: http://www.aetna.com/cpb/medical/data/600_699/0666.html. [ Links ]
2. Binkley N. Osteoporosis in men. Arq Bras Endocrinol Metab [periódico na internet]. 2006 [acesso em 6 mar 2013];50(4):764-74. Disponível em: http://www.scielo.br/pdf/abem/v50n4/31877.pdf [ Links ]
3. Blue Cross Blue Shield of Illnois. Forteo® (teriparatide) prior authorization coverage criteria [monografia na internet]. 2011. [acesso em 15 dez 2011]. Disponível em: http://www.bcbsal.org/providers/pharmPolicies/final/0179.pdf. [ Links ]
4. Body JJ, Gaich GA, Scheele WH, Kulkarni PM, Miller PD, Peretz A, et al. A randomized double-blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (1-34)] with alendronate in postmenopausal women with osteoporosis. J Clin Endocrinol Metab [periódico na internet]. 2002 [acesso em 6 mar 2013]; 87(10):4528-35. Disponível em: http://jcem.endojournals.org/content/87/10/4528.full.pdf+html [ Links ]
5. Borba VZ C, Mañas NCP. The use of PTH in the treatment of osteoporosis. Arq Bras Endocrinol Metabol [periódico na internet]. 2010 [acesso em 6 mar 2013];54(2):213-9. Disponível em http://www.scielo.br/pdf/abem/v54n2/18.pdf [ Links ]
6. Borgström F, Ström O, Marin F, Kutahov A, Ljunggren O. Cost effectiveness of teriparatide and PTH(1-84) in the treatment of postmenopausal osteoporosis. J Med Econ. 2010;13(3);381-92. [ Links ]
7. Bouxsein ML, Chen P, Glass VE, Kallmes DF, Delmas PD, Mitlak BH. Teriparatide and raloxifene reduce the risk of new adjacent vertebral fractures in postmenopausal women with osteoporosis. Results from two randomized controlled trials. J Bone Joint Surg Am. 2009; 91(6):1329-38. [ Links ]
8. Brandão CMR, Lima MG, Silva AL, Silva GD, Guerra Júnior AA, Acúrcio FA. Treatment of postmenopausal osteoporosis in women: a systematic review. Cad Saude Pública [periódico na internet]. 2008 [acesso em 6 mar 2013];24(suppl.4):592-606. Disponível em http://www.scielo.br/pdf/csp/v24s4/11.pdf [ Links ]
9. Canadian Agency for Drugs and Technologies in Health. Teriparatide. ACP Submission (Forteo – Eli Lilly Canada Inc.). Indication: severe osteoporosis in women [monografia na internet]. 2010 [acesso em 15 dez 2011]. Disponível em: http://www.cadth.ca/media/cdr/complete/cdr_complete_Forteo-ACP_March-17-2010.pdf. [ Links ]
10. Centro Cochrane do Brasil. Teriparatida (hormônio da paratireoide recombinante humana 1-340) para o tratamento da osteoporose em mulheres pós-menopausa [monografia na internet]. São Paulo; 2005. [acesso em 15 dez 2011]. Disponível em: http://portal.saude.gov.br/portal/arquivos/pdf/teriparatida_para_osteoporose_txt.pdf [ Links ]
11. Chieffi AL, Barata RCB. Ações judiciais: estratégia da indústria farmacêutica para introdução de novos medicamentos. Rev Saúde Pública [periódico na internet]. 2010 [acesso em 6 mar 2013];44(3):421-9. Disponível em: http://www.scielo.br/pdf/rsp/v44n3/05.pdf [ Links ]
12. Cosman F, Eriksen EF , Recknor C, Miller PD , Guañabens N, Kasperk C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res [periódico na internet]. 2011 [acesso em 6 mar 2013];26(3);5003-11. Disponível em: http://onlinelibrary.wiley.com/doi/10.1002/jbmr.238/pdf [ Links ]
13. Cosman F, Nieves J, Zion M , Woelfert L, Luckey M, Lindsay R.. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med [periódico na internet]. 2005 [acesso em 6 mar 2013];353:566–75. Disponível em: http://www.nejm.org/doi/pdf/10.1056/NEJMoa050157 [ Links ]
14. Federação Brasileira das Associações de Ginecologia e Obstetrícia e Sociedade Brasileira de Reumatologia. Diretrizes Clínicas na Saúde Suplementar. Osteoporose: tratamento [monografia na internet]. Brasília (DF): Agência Nacional de Saúde Suplementar; 2011. [acesso em 29 nov 2011]. Disponível em: http://www.projetodiretrizes.org.br/ans/diretrizes/osteoporose-tratamento.pdf. [ Links ]
15. Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocr Metab [periódico na internet]. 2010 [acesso em 6 mar 2013];95:1838–45. Disponível em: http://jcem.endojournals.org/content/95/4/1838.full.pdf+html [ Links ]
16. Eli Lilly. Forteo: highlights of prescribing information [monografia na internet]. Indianápolis; 2002. 14p. [acesso em 5 dez 2011] Disponível em: http://pi.lilly.com/us/forteo-pi.pdf. [ Links ]
17. Gallacher SJ, Dixon T. Impact of treatments for postmenopausal osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate, and denosumab) on bone quality: a systematic review. Calcif Tissue Int. 2009; 87(6): 469-84. [ Links ]
18. Guarniero R, Oliveira L G. Osteoporose: atualização no diagnóstico e princípios básicos para o tratamento. Rev Bras Ortop. 2004; 39 (9): 477-85. [ Links ]
19. Han SL, Wan SL. Effect of teriparatide on bone mineral density and fracture in postmenopausal osteoporosis: meta-analysis of randomised controlled trials. Int J Clin Pract. 2012;66(2):199-209. [ Links ]
20. Liu H, Michaud K, Nayak S, Karpf DB, Owens DK, Garber AM. The cost-effectiveness of therapy with teriparatide and alendronate in women with severe osteoporosis. Arch Intern Med [periódico na internet]. 2006 [acesso em 6 mar 2013];166(11):1209-17. Disponível em: http://archinte.jamanetwork.com/article.aspx?articleid=410445 [ Links ]
21. MacLean C, Maglione SNM, McMahon M, Ranganath V, Suttorp M, Mojica W, et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med [periódico na internet]. 2008 [acesso em 6 mar 2013];148(3):197-213. Disponível em: http://annals.org/article.aspx?articleid=739219 [ Links ]
22. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes metodológicas: elaboração de pareceres técnico-científicos [monografia na internet]. 3.ed.rev.atual. Brasília (DF): 2011. 80p. (Série A. Normas e manuais técnicos). [acesso em 23 jan 2012]. Disponível em: http://portal.saude.gov.br/portal/arquivos/pdf/DiretrizesPTC.pdf
23. Nakamura T, Sugimoto T, Nakano T, Kishimoto H, Ito M, Fukunaga M, et al. Randomized Teriparatide [human parathyroid hormone (PTH) 1-34] once-weekly efficacy research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk. J Clin Endocrinol Metab. 2012;97(9):3097-106. [ Links ]
24. National Institute for Health and Clinical Excellence. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women [monografia na internet]. London; 2010. 82p. [acesso em 15 dez 2011]. Disponível em: http://guidance.nice.org.uk/TA161. [ Links ]
25. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, et al. Effect of parathy¬roid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med [periódico na internet]. 2001 [acesso em 6 mar 2013];344(19):1434-41. Disponível em: http://www.nejm.org/doi/pdf/10.1056/NEJM200105103441904 [ Links ]
26. Panico AABDE, Lupoli GADE, Marciello FC, Lupoli RB, Cacciapuoti ME, Martinelli AF, et al. Teriparatide vs. alendronate as a treatment for osteoporosis: changes in biochemical markers of bone turnover, BMD and quality of life. Med Sci Monit. 2011; 17(8):442-8. [ Links ]
27. Prevrhal A, Krege JH, Chen PC, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009; 25(4):921-8. [ Links ]
28. Rizzoli R. Bisphosphonates for post-menopausal osteoporosis: are they all the same? QJM [periódico na internet]. 2011 [acesso em 6 mar 2013];104(4):281-300. Disponível em: http://qjmed.oxfordjournals.org/content/104/4/281.full.pdf+html [ Links ]
29. Sethi BK , Chadha M , Modi KD , Prasanna Kumar KM , Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis-an Indian experience. J Assoc Physicians India [periódico na internet]. 2008 [acesso em 6 mar 2013];56:418-42. Disponível em: http://www.japi.org/june_2008/O-418.pdf [ Links ]
30. Trevisani VFM, Riera R, Mizusaki IA, Saconato H, Atallah AN. Teriparatide (recombinant human parathyroid hormone 1-34) in postmenopausal women with osteoporosis: systematic review. São Paulo Med J [periódico na internet]. 2008 [acesso em 6 mar 2013];126(5):279-84. Disponível em: http://www.scielo.br/pdf/spmj/v126n5/07.pdf [ Links ]
31. Vahle JL, Sato M, Long GG, Long, JK, Young, PC. Francis, J A, et al. Skeletal changes in rats given daily subcutaneous injection of recombinant human parathyroid hormone (rc1-34) for 2 years and relevance to human safety. Toxicol Pathol [periódico na internet]. 2002 [acesso em 6 mar 2013];30:312-21. Disponível em: http://tpx.sagepub.com/content/30/3/312.long [ Links ]
2. Binkley N. Osteoporosis in men. Arq Bras Endocrinol Metab [periódico na internet]. 2006 [acesso em 6 mar 2013];50(4):764-74. Disponível em: http://www.scielo.br/pdf/abem/v50n4/31877.pdf [ Links ]
3. Blue Cross Blue Shield of Illnois. Forteo® (teriparatide) prior authorization coverage criteria [monografia na internet]. 2011. [acesso em 15 dez 2011]. Disponível em: http://www.bcbsal.org/providers/pharmPolicies/final/0179.pdf. [ Links ]
4. Body JJ, Gaich GA, Scheele WH, Kulkarni PM, Miller PD, Peretz A, et al. A randomized double-blind trial to compare the efficacy of teriparatide [recombinant human parathyroid hormone (1-34)] with alendronate in postmenopausal women with osteoporosis. J Clin Endocrinol Metab [periódico na internet]. 2002 [acesso em 6 mar 2013]; 87(10):4528-35. Disponível em: http://jcem.endojournals.org/content/87/10/4528.full.pdf+html [ Links ]
5. Borba VZ C, Mañas NCP. The use of PTH in the treatment of osteoporosis. Arq Bras Endocrinol Metabol [periódico na internet]. 2010 [acesso em 6 mar 2013];54(2):213-9. Disponível em http://www.scielo.br/pdf/abem/v54n2/18.pdf [ Links ]
6. Borgström F, Ström O, Marin F, Kutahov A, Ljunggren O. Cost effectiveness of teriparatide and PTH(1-84) in the treatment of postmenopausal osteoporosis. J Med Econ. 2010;13(3);381-92. [ Links ]
7. Bouxsein ML, Chen P, Glass VE, Kallmes DF, Delmas PD, Mitlak BH. Teriparatide and raloxifene reduce the risk of new adjacent vertebral fractures in postmenopausal women with osteoporosis. Results from two randomized controlled trials. J Bone Joint Surg Am. 2009; 91(6):1329-38. [ Links ]
8. Brandão CMR, Lima MG, Silva AL, Silva GD, Guerra Júnior AA, Acúrcio FA. Treatment of postmenopausal osteoporosis in women: a systematic review. Cad Saude Pública [periódico na internet]. 2008 [acesso em 6 mar 2013];24(suppl.4):592-606. Disponível em http://www.scielo.br/pdf/csp/v24s4/11.pdf [ Links ]
9. Canadian Agency for Drugs and Technologies in Health. Teriparatide. ACP Submission (Forteo – Eli Lilly Canada Inc.). Indication: severe osteoporosis in women [monografia na internet]. 2010 [acesso em 15 dez 2011]. Disponível em: http://www.cadth.ca/media/cdr/complete/cdr_complete_Forteo-ACP_March-17-2010.pdf. [ Links ]
10. Centro Cochrane do Brasil. Teriparatida (hormônio da paratireoide recombinante humana 1-340) para o tratamento da osteoporose em mulheres pós-menopausa [monografia na internet]. São Paulo; 2005. [acesso em 15 dez 2011]. Disponível em: http://portal.saude.gov.br/portal/arquivos/pdf/teriparatida_para_osteoporose_txt.pdf [ Links ]
11. Chieffi AL, Barata RCB. Ações judiciais: estratégia da indústria farmacêutica para introdução de novos medicamentos. Rev Saúde Pública [periódico na internet]. 2010 [acesso em 6 mar 2013];44(3):421-9. Disponível em: http://www.scielo.br/pdf/rsp/v44n3/05.pdf [ Links ]
12. Cosman F, Eriksen EF , Recknor C, Miller PD , Guañabens N, Kasperk C, et al. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res [periódico na internet]. 2011 [acesso em 6 mar 2013];26(3);5003-11. Disponível em: http://onlinelibrary.wiley.com/doi/10.1002/jbmr.238/pdf [ Links ]
13. Cosman F, Nieves J, Zion M , Woelfert L, Luckey M, Lindsay R.. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med [periódico na internet]. 2005 [acesso em 6 mar 2013];353:566–75. Disponível em: http://www.nejm.org/doi/pdf/10.1056/NEJMoa050157 [ Links ]
14. Federação Brasileira das Associações de Ginecologia e Obstetrícia e Sociedade Brasileira de Reumatologia. Diretrizes Clínicas na Saúde Suplementar. Osteoporose: tratamento [monografia na internet]. Brasília (DF): Agência Nacional de Saúde Suplementar; 2011. [acesso em 29 nov 2011]. Disponível em: http://www.projetodiretrizes.org.br/ans/diretrizes/osteoporose-tratamento.pdf. [ Links ]
15. Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocr Metab [periódico na internet]. 2010 [acesso em 6 mar 2013];95:1838–45. Disponível em: http://jcem.endojournals.org/content/95/4/1838.full.pdf+html [ Links ]
16. Eli Lilly. Forteo: highlights of prescribing information [monografia na internet]. Indianápolis; 2002. 14p. [acesso em 5 dez 2011] Disponível em: http://pi.lilly.com/us/forteo-pi.pdf. [ Links ]
17. Gallacher SJ, Dixon T. Impact of treatments for postmenopausal osteoporosis (bisphosphonates, parathyroid hormone, strontium ranelate, and denosumab) on bone quality: a systematic review. Calcif Tissue Int. 2009; 87(6): 469-84. [ Links ]
18. Guarniero R, Oliveira L G. Osteoporose: atualização no diagnóstico e princípios básicos para o tratamento. Rev Bras Ortop. 2004; 39 (9): 477-85. [ Links ]
19. Han SL, Wan SL. Effect of teriparatide on bone mineral density and fracture in postmenopausal osteoporosis: meta-analysis of randomised controlled trials. Int J Clin Pract. 2012;66(2):199-209. [ Links ]
20. Liu H, Michaud K, Nayak S, Karpf DB, Owens DK, Garber AM. The cost-effectiveness of therapy with teriparatide and alendronate in women with severe osteoporosis. Arch Intern Med [periódico na internet]. 2006 [acesso em 6 mar 2013];166(11):1209-17. Disponível em: http://archinte.jamanetwork.com/article.aspx?articleid=410445 [ Links ]
21. MacLean C, Maglione SNM, McMahon M, Ranganath V, Suttorp M, Mojica W, et al. Systematic review: comparative effectiveness of treatments to prevent fractures in men and women with low bone density or osteoporosis. Ann Intern Med [periódico na internet]. 2008 [acesso em 6 mar 2013];148(3):197-213. Disponível em: http://annals.org/article.aspx?articleid=739219 [ Links ]
22. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes metodológicas: elaboração de pareceres técnico-científicos [monografia na internet]. 3.ed.rev.atual. Brasília (DF): 2011. 80p. (Série A. Normas e manuais técnicos). [acesso em 23 jan 2012]. Disponível em: http://portal.saude.gov.br/portal/arquivos/pdf/DiretrizesPTC.pdf
23. Nakamura T, Sugimoto T, Nakano T, Kishimoto H, Ito M, Fukunaga M, et al. Randomized Teriparatide [human parathyroid hormone (PTH) 1-34] once-weekly efficacy research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk. J Clin Endocrinol Metab. 2012;97(9):3097-106. [ Links ]
24. National Institute for Health and Clinical Excellence. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women [monografia na internet]. London; 2010. 82p. [acesso em 15 dez 2011]. Disponível em: http://guidance.nice.org.uk/TA161. [ Links ]
25. Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, et al. Effect of parathy¬roid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med [periódico na internet]. 2001 [acesso em 6 mar 2013];344(19):1434-41. Disponível em: http://www.nejm.org/doi/pdf/10.1056/NEJM200105103441904 [ Links ]
26. Panico AABDE, Lupoli GADE, Marciello FC, Lupoli RB, Cacciapuoti ME, Martinelli AF, et al. Teriparatide vs. alendronate as a treatment for osteoporosis: changes in biochemical markers of bone turnover, BMD and quality of life. Med Sci Monit. 2011; 17(8):442-8. [ Links ]
27. Prevrhal A, Krege JH, Chen PC, Genant H, Black DM. Teriparatide vertebral fracture risk reduction determined by quantitative and qualitative radiographic assessment. Curr Med Res Opin. 2009; 25(4):921-8. [ Links ]
28. Rizzoli R. Bisphosphonates for post-menopausal osteoporosis: are they all the same? QJM [periódico na internet]. 2011 [acesso em 6 mar 2013];104(4):281-300. Disponível em: http://qjmed.oxfordjournals.org/content/104/4/281.full.pdf+html [ Links ]
29. Sethi BK , Chadha M , Modi KD , Prasanna Kumar KM , Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis-an Indian experience. J Assoc Physicians India [periódico na internet]. 2008 [acesso em 6 mar 2013];56:418-42. Disponível em: http://www.japi.org/june_2008/O-418.pdf [ Links ]
30. Trevisani VFM, Riera R, Mizusaki IA, Saconato H, Atallah AN. Teriparatide (recombinant human parathyroid hormone 1-34) in postmenopausal women with osteoporosis: systematic review. São Paulo Med J [periódico na internet]. 2008 [acesso em 6 mar 2013];126(5):279-84. Disponível em: http://www.scielo.br/pdf/spmj/v126n5/07.pdf [ Links ]
31. Vahle JL, Sato M, Long GG, Long, JK, Young, PC. Francis, J A, et al. Skeletal changes in rats given daily subcutaneous injection of recombinant human parathyroid hormone (rc1-34) for 2 years and relevance to human safety. Toxicol Pathol [periódico na internet]. 2002 [acesso em 6 mar 2013];30:312-21. Disponível em: http://tpx.sagepub.com/content/30/3/312.long [ Links ]
This work is licensed under a Creative Commons Attribution 4.0 International License.
Copyright (c) 2013 Marília Cristina Prado Louvison, Ana Aparecida Sanches Bersusa, Eliane Molina Psaltikidis, Andréia Nascimento
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