EARLIER: an Observational Study to Evaluate the Use of Cinacalcet in Incident Hemodialysis Patients with Secondary Hyperparathyroidism in Daily Clinical Practice

Overview

Journal Wien Med Wochenschr

Specialty General Medicine

Date 2015 Aug 26

PMID 26302869

Authors

Margit Hemetsberger

Rainer Oberbauer

Helmut Erb

Wolfgang Pronai

Affiliations

Soon will be listed here.

Abstract

The EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) observational postmarketing surveillance study evaluated incident hemodialysis patients (< 1 year dialysis vintage; n = 146) receiving cinacalcet in Austrian clinical practice. Despite intervention with vitamin D sterols and phosphate binders, 24 % had already developed severe SHPT (intact parathyroid hormone (iPTH) > 800 pg/mL) at baseline. After cinacalcet was started, median iPTH decreased substantially, from 611 pg/mL to 251 pg/mL (median decrease 58 % [IQR - 36 to - 78 %] at 12 months. Overall, 36 % of patients achieved the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range (150-300 pg/mL) for iPTH; this included 35 % of those with severe SHPT at baseline. Serum phosphorus (P), calcium (Ca) (corr), and Ca (corr) × P also decreased, with 43, 34, and 62 % of patients, respectively, reaching K/DOQI targets at 12 months. Thus, in this observational study, mineral metabolism in incident dialysis patients with SHPT improved after starting cinacalcet.

References

Billa V, Zhong A, Bargman J, Vas S, Wong P, Oreopoulos D . High prevalence of hyperparathyroidism among peritoneal dialysis patients: a review of 176 patients. Perit Dial Int. 2000; 20(3):315-21. View

Tominaga Y, Takagi H . Molecular genetics of hyperparathyroid disease. Curr Opin Nephrol Hypertens. 1996; 5(4):336-41. DOI: 10.1097/00041552-199607000-00008. View

Chonchol M, Locatelli F, Abboud H, Charytan C, de Francisco A, Jolly S . A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet HCl in participants with CKD not receiving dialysis. Am J Kidney Dis. 2008; 53(2):197-207. DOI: 10.1053/j.ajkd.2008.09.021. View

. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003; 42(4 Suppl 3):S1-201. View

Messa P, Macario F, Yaqoob M, Bouman K, Braun J, von Albertini B . The OPTIMA study: assessing a new cinacalcet (Sensipar/Mimpara) treatment algorithm for secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2008; 3(1):36-45. PMC: 2390975. DOI: 10.2215/CJN.03591006. View

Lindberg J, Culleton B, Wong G, Borah M, Clark R, Shapiro W . Cinacalcet HCl, an oral calcimimetic agent for the treatment of secondary hyperparathyroidism in hemodialysis and peritoneal dialysis: a randomized, double-blind, multicenter study. J Am Soc Nephrol. 2005; 16(3):800-7. DOI: 10.1681/ASN.2004060512. View

Kestenbaum B, Belozeroff V . Mineral metabolism disturbances in patients with chronic kidney disease. Eur J Clin Invest. 2007; 37(8):607-22. DOI: 10.1111/j.1365-2362.2007.01840.x. View

Meola M, Petrucci I, Barsotti G . Long-term treatment with cinacalcet and conventional therapy reduces parathyroid hyperplasia in severe secondary hyperparathyroidism. Nephrol Dial Transplant. 2009; 24(3):982-9. PMC: 2644631. DOI: 10.1093/ndt/gfn654. View

Slatopolsky E, Brown A, Dusso A . Pathogenesis of secondary hyperparathyroidism. Kidney Int Suppl. 2000; 73:S14-9. DOI: 10.1046/j.1523-1755.1999.07304.x. View

10.

Moe S, Drueke T, Cunningham J, Goodman W, Martin K, Olgaard K . Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2006; 69(11):1945-53. DOI: 10.1038/sj.ki.5000414. View

11.

Block G, Martin K, de Francisco A, Turner S, Avram M, Suranyi M . Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004; 350(15):1516-25. DOI: 10.1056/NEJMoa031633. View

12.

Salem M . Hyperparathyroidism in the hemodialysis population: a survey of 612 patients. Am J Kidney Dis. 1997; 29(6):862-5. DOI: 10.1016/s0272-6386(97)90459-5. View

13.

Komaba H, Nakanishi S, Fujimori A, Tanaka M, Shin J, Shibuya K . Cinacalcet effectively reduces parathyroid hormone secretion and gland volume regardless of pretreatment gland size in patients with secondary hyperparathyroidism. Clin J Am Soc Nephrol. 2010; 5(12):2305-14. PMC: 2994093. DOI: 10.2215/CJN.02110310. View

14.

Zitt E, Jager C, Rosenkranz A, Eigner M, Kodras K, Kovarik J . Effective use of cinacalcet for the treatment of secondary hyperparathyroidism in Austrian dialysis patients--results of the Austrian cohort of the ECHO study. Wien Klin Wochenschr. 2011; 123(1-2):45-52. DOI: 10.1007/s00508-010-1515-x. View

15.

. 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):S1-130. DOI: 10.1038/ki.2009.188. View

16.

Terawaki H, Nakano H, Takeguchi F, Hasegawa T, Nakayama M, Okazaki M . Regression of parathyroid gland swelling by treatment with cinacalcet. Nephrol Dial Transplant. 2008; 24(2):690-1. DOI: 10.1093/ndt/gfn579. View

17.

Block G . The impact of calcimimetics on mineral metabolism and secondary hyperparathyroidism in end-stage renal disease. Kidney Int Suppl. 2003; (87):S131-6. DOI: 10.1046/j.1523-1755.64.s87.20.x. View

18.

Block G, Klassen P, Lazarus J, Ofsthun N, Lowrie E, Chertow G . Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004; 15(8):2208-18. DOI: 10.1097/01.ASN.0000133041.27682.A2. View

19.

Drueke T, Martin D, Rodriguez M . Can calcimimetics inhibit parathyroid hyperplasia? Evidence from preclinical studies. Nephrol Dial Transplant. 2007; 22(7):1828-39. DOI: 10.1093/ndt/gfm177. View

20.

Komaba H, Fukagawa M . Regression of parathyroid hyperplasia by calcimimetics--fact or illusion?. Nephrol Dial Transplant. 2008; 24(3):707-9. DOI: 10.1093/ndt/gfn717. View