Cinacalcet treatment for secondary hyperparathyroidism in dialysis patients: An observational study in routine clinical practice

Nephron - Clinical Practice

Volumn 118, Issue 2, 2011, Pages

  Bover, Jordi ^a   Perez, Rafael ^b   Molina, Manuel ^c   Benavides, Beatriz ^d   Ariza, Francisco ^e   Miguel, José Luis ^f   Tornero, Fernando ^g   Torregrosa, Josep Vicens ^h,i  

^a FUNDACIÓ PUIGVERT   (Spain)

^b HOSPITAL UNIVERSITARIO INFANTA LEONOR   (Spain)

^c Allergy Section   (Spain)

^d HOSPITAL UNIVERSITARIO DE PUERTO REAL   (Spain)

^e HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

^f HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^g HOSPITAL VIRGEN DE LA LUZ   (Spain)

^h HOSPITAL CLÍNIC   (Spain)

ⁱ NONE   (Spain)

Author keywords

Calcimimetic; Calcium; Cinacalcet; Dialysis; Parathyroid hormone; Phosphorus; Secondary hyperparathyroidism

Indexed keywords

ALFACALCIDOL; CALCITRIOL; CALCIUM CARBONATE; CALCIUM DERIVATIVE; CALCIUM GLUCOBIONATE; CINACALCET; MAGALDRATE; PARATHYROID HORMONE; PARICALCITOL; SEVELAMER; SUCRALFATE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; ARTICLE; CLINICAL PRACTICE; CONSTIPATION; DIALYSIS; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EPIGASTRIC PAIN; FEMALE; GASTRITIS; HEALTH CARE QUALITY; HUMAN; HYPOCALCEMIA; LIP PARESTHESIA; MAJOR CLINICAL STUDY; MALAISE; MALE; MYALGIA; NAUSEA; OBSERVATIONAL STUDY; PARATHYROID HORMONE BLOOD LEVEL; PARESTHESIA; PRETIBIAL ULCER; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SECONDARY HYPERPARATHYROIDISM; SPAIN; ULCER; VOMITING;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; HUMANS; HYPERPARATHYROIDISM, SECONDARY; MALE; MIDDLE AGED; NAPHTHALENES; PARATHYROID HORMONE; RENAL DIALYSIS; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 78649791935     PISSN: 16602110     EISSN: 16602110     Source Type: Journal    
DOI: 10.1159/000319882     Document Type: Article

References (37)

1. Owda A, Elhwairis H, Narra S, Towery H, Osama S: Secondary hyperparathyroidism in chronic hemodialysis patients: Prevalence and race. Ren Fail 2003; 25: 595-602. (Pubitemid 36944739)
2. Slatopolsky E, Brown A, Dusso A: Pathogenesis of secondary hyperparathyroidism. Kidney Int Suppl 1999; 73:S14-S19. (Pubitemid 30012822)
3. Ganesh SK, Stack AG, Levin NW, Hulbert- Shearon T, Port FK: Association of elevated serum PO 4 , Ca ! PO 4 product, and parathyroid hormone with cardiac mortality risk in chronic hemodialysis patients. J Am Soc Nephrol 2001; 12: 2131-2138. (Pubitemid 32880350)
4. National Kidney Foundation: K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42(suppl 3):S1-S201.
5. Block GA, Port FK: Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: Recommendations for a change in management. Am J Kidney Dis 2000; 35: 1226-1237. (Pubitemid 30354431)
6. Nemeth EF, Steffey ME, Hammerland LG, Hung BC, Van Wagenen BC, DelMar EG, Balandrin MF: Calcimimetics with potent and selective activity on the parathyroid calcium receptor. Proc Natl Acad Sci USA 1998; 95: 4040-4045. (Pubitemid 28173250)
7. Fox J, Lowe SH, Conklin RL, Nemeth EF: The calcimimetic NPS R-568 decreases plasma PTH in rats with mild and severe renal or dietary secondary hyperparathyroidism. Endocrine 1999; 10: 97-103. (Pubitemid 29295782)
8. Silver J, Naveh-Many T: Phosphate and the parathyroid. Kidney Int 2009; 75: 898-905.
9. Block GA, Martin KJ, de Francisco AL, Turner SA, Avram MM, Suranyi MG, Hercz G, Cunningham J, Abu-Alfa AK, Messa P, Coyne DW, Locatelli F, Cohen RM, Evenepoel P, Moe SM, Fournier A, Braun J, McCary LC, Zani VJ, Olson KA, Drüeke TB, Goodman WG: Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med 2004; 350: 1516-1525. (Pubitemid 38477776)
10. Lindberg JS, Culleton B, Wong G, Borah MF, Clark RV, Shapiro WB, Roger SD, Husserl FE, Klassen PS, Guo MD, Albizem MB, Coburn JW: Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: A randomized, doubleblind, multicenter study. J Am Soc Nephrol 2005; 16: 800-807. (Pubitemid 41725117)
11. Ureña P, Jacobson SH, Zitt E, Vervloet M, Malberti F, Ashman N, Leavey S, Rix M, Os I, Saha H, Ryba M, Bencova V, Baños A, Zani V, Fouque D: Cinacalcet and achievement of the NKF/K-DOQITM recommended target values for bone and mineral metabolism in real-world clinical practice - the ECHO observational study. Nephrol Dial Transplant 2009; 24: 2852-2859.
12. St Peter WL, Li Q, Liu J, Persky M, Nieman K, Arko C, Block GA: Cinacalcet use patterns and effect on laboratory values and other medications in a large dialysis organization, 2004 through 2006. Clin J Am Soc Nephrol 2009; 4: 354-360.
13. Torregrosa JV, Cannata Andia J, Bover J, Caravaca F, Lorenzo V, Martín de Francisco AL, Martín-Malo A, Martínez I, González Parra E, Fernández Giráldez E, Rodríguez Portillo M; Sociedad Española de Nefrologia: Guias SEN: Recomendaciones de la Sociedad Espanola de Nefrología para el ma nejo de las alteraciones del metabolismo oseo-mineral en los pacientes con enfermedad renal crónica. Nefrologia 2008; 28(suppl 1):1-22.
14. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl 2009;(113):S1-S130.
15. de la Piedra C, Fernández E, González Casaus ML, González Parra E: Diferencias en la función de los péptidos paratiroideos. Qué estamos midiendo? Nefrología 2008; 28: 123-128.
16. Floege J, Kim J, Ireland E, Chazot C, Drueke T, de Francisco A, Kronenberg F, Marcelli D, Passlick-Deetjen J, Schernthaner G, Fouqueray B, Wheeler DC; on behalf of the ARO Investigators: Serum iPTH, calcium and phosphate, and the risk of mortality in a European haemodialysis population. Nephrol Dial Transplant. 2010:Apr 25. Epub ahead of print.
17. Sociedad Española de Nefrología-Grupo de Registros de Enfermos Renales: Diálisis y Trasplante 2006 (Informe preliminar). http://www.senefro.org/modules/subsection/ files/informe-registro-enfermos- renales-2006.pdf?check-idfile=2923. Accessed on April, 7th, 2009.
18. Alcázar JM, Arenas MD, Alvarez-Ude F, Virto R, Rubio E, Maduell F, Fernández-Crespo P, Angoso de Guzmán M, Ramón Delgado R, Santamaría C, Alonso MA, Anaya S, Bordils A, Antolín A, Gonzalez-Parra E, Pérez I, Molina Ordás A, Fernández M, Molina P, Sánchez P, Barbosa F, Palomares Solla L, Lacueva J, Barril G, Pastor JM, Gámez Matías C, Mateos Hernández P, Fulquet Nicolas M, Ríos F, Rebollo P, Parra E: Resultados del proyecto de mejora de la calidad de la asistencia en hemodiálisis: Estudio multicéntrico de indicadores de calidad de la Sociedad Española de Nefrología (SEN). Nefrologia 2008; 28: 597-606.
19. Avram MM, Mittman N, Myint MM, Fein P: Importance of low serum intact parathyroid hormone as a predictor of mortality in hemodialysis and peritoneal dialysis patients: 14 years of prospective observation. Am J Kidney Dis 2001; 38: 1351-1357. (Pubitemid 34193126)
20. Moe SM, Chertow GM, Coburn JW, Quarles LD, Goodman WG, Block GA, Drüeke TB, Cunningham J, Sherrard DJ, McCary LC, Olson KA, Turner SA, Martin KJ: Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int 2005; 67: 760-771. (Pubitemid 40139871)
21. EPARs for authorized medicinal products for human use. http://www.emea.europa.eu/ humandocs/Humans/EPAR/mimpara/ mimpara.htm.
22. Sterrett JR, Strom J, Stummvoll HK, Bahner U, Disney A, Soroka SD, Corpier C, Arruda JA, Schwanauer LE, Klassen PS, Olson KA, Block GA: Cinacalcet HCl (Sensipar/Mimpara) is an effective chronic therapy for hemodialysis patients with secondary hyperparathyroidism. Clin Nephrol 2007; 68: 10-17. (Pubitemid 47045487)
23. Messa P, Macário F, Yaqoob M, Bouman K, Braun J, von Albertini B, Brink H, Maduell F, Graf H, Frazão JM, Bos WJ, Torregrosa V, Saha H, Reichel H, Wilkie M, Zani VJ, Molemans B, Carter D, Locatelli F: The OPTIMA study: Assessing a new cinacalcet (Sensipar/ Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol 2008; 3: 36-45.
24. Schaefer RM, Bover J, Dellanna F, Sanz D, Asensio C, Sánchez González MC, Gross P, Zani V, Carter D, Jehle PM: Efficacy of cinacalcet administered with the first meal after dialysis: The SENSOR Study. Clin Nephrol 2008; 70: 126-134.
25. Padhi D, Harris RZ, Salfi M, Noveck RJ, Sullivan JT: Pharmacokinetics and pharmacodynamics of cinacalcet in hepatic impairment: Phase I, open-label, parallel-group, single-dose, single-centre study. Clin Drug Investig 2008; 28: 635-643.
26. Strippoli GF, Tong A, Palmer SC, Elder G, Craig JC: Calcimimetics for secondary hyperparathyroidism in chronic kidney disease patients. Cochrane Database Syst Rev 2006; 18(4): CD006254 Review.
27. Block GA, Zeig S, Sugihara J, Chertow GM, Chi EM, Turner SA, Bushinsky DA: Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrol Dial Transplant 2008; 23: 2311-2318. (Pubitemid 351957604)
28. Andress DL: Vitamin D in chronic kidney disease: A systemic role for selective vitamin D receptor activation. Kidney Int 2006; 69: 33-43. (Pubitemid 43117736)
29. Matias PJ, Jorge C, Ferreira C, Borges M, Aires I, Amaral T, Gil C, Cortez J, Ferreira A: Cholecalciferol supplementation in hemodialysis patients: Effects on mineral metabolism, inflammation, and cardiac dimension parameters. Clin J Am Soc Nephrol 2010; 5: 905-911.
30. Arenas MD, Rebollo P, Alvarez-Ude F, Prieto L, Gil MT, Malek T, Moledous A, Núñez C: Es el cinacalcet un tratamiento coste-efectivo en el hiperparatiroidismo secundario severo en pacientes en hemodialisis? Nefrologia 2008; 28: 511-516.
31. Chertow GM, Burke SK, Raggi P; Treat to Goal Working Group: Sevelamer attenuates the progression of coronary and aortic calcification in hemodialysis patients. Kidney Int 2002; 62: 245-252. (Pubitemid 34754068)
32. Arenas MD, Alvarez-Ude F, Gil MT, Soriano A, Egea JJ, Millán I, Amoedo ML, Muray S, Carretón MA: Application of NKF-K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease: Changes of clinical practices and their effects on outcomes and quality standards in three haemodialysis units. Nephrol Dial Transplant 2006; 21: 1663-1668. (Pubitemid 43834646)
33. Lorenzo V, Martin-Malo A, Perez-Garcia R, Torregrosa JV, Vega N, de Francisco AL, Cases A: Prevalence, clinical correlates and therapy cost of mineral abnormalities among haemodialysis patients: A cross-sectional multicentre study. Nephrol Dial Transplant 2006; 21: 459-465. (Pubitemid 43160003)
34. Ashman N, Fouque D, Baños A, Harris C, Stefan H, Jacobson on Behalf of the Pan-European ECHO Study Investigator Group: The ECHO Study: The use of cinacalcet (Mimpara /Sensipar ) in patients receiving/ not receiving vitamin D in clinical practice (Abstract). ERA-EDTA, Stockholm, May 2008.
35. Cunningham J, Danese M, Olson K, Klassen P, Chertow GM: Effects of the calcimimetic cinacalcet HCl on cardiovascular disease, fracture, and health-related quality of life in secondary hyperparathyroidism. Kidney Int 2005; 68: 1793-1800. (Pubitemid 43169924)
36. http://clinicaltrials.gov/ct2/show/NCT0037 9899?term=cinacalcet&rank= 2
37. Chertow GM, Pupim LB, Block GA, Correa- Rotter R, Drueke TB, Floege J, Goodman WG, London GM, Mahaffey KW, Moe SM, Wheeler DC, Albizem M, Olson K, Klassen P, Parfrey P: Evaluation of cinacalcet therapy to lower cardiovascular events (EVOLVE): Rationale and design overview. Clin J Am Soc Nephrol 2007; 2: 898-905.