Journal Article

Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism

Geoffrey A. Block, Steven Zeig, Jared Sugihara, Glenn M. Chertow, Eric M. Chi, Stewart A. Turner and David A. Bushinsky

in Nephrology Dialysis Transplantation

Published on behalf of European Renal Association - European Dialysis and Transplant Assoc

Volume 23, issue 7, pages 2311-2318
Published in print July 2008 | ISSN: 0931-0509
Published online February 2008 | e-ISSN: 1460-2385 | DOI: http://dx.doi.org/10.1093/ndt/gfn026
Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism

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Background. Adequate control of all four KDOQITM biochemical targets for chronic kidney disease, bone and mineral disorder (CKD-MBD), which include parathyroid hormone (PTH), calcium (Ca), phosphorus (P) and Ca × P, remains difficult and is accomplished in <6% of patients receiving haemodialysis. The objective of the current study was to determine whether treatment with cinacalcet combined with low doses of vitamin D sterols improves control of both PTH and Ca × P among haemodialysis patients with secondary hyperparathyroidism (sHPT).

Methods. This multicentre, open-label study enrolled haemodialysis subjects (N = 444) with moderate to severe sHPT (mean serum biPTH > 160–430 pg/mL) (∼iPTH 300–800 pg/mL or ng/L). Cinacalcet was titrated sequentially (30–180 mg/day) during an 8-week dose-titration phase to achieve biPTH ≤160 pg/mL (∼iPTH 300 pg/mL or ng/L) and efficacy was assessed over 8 weeks. At week 2 of the study, subjects receiving vitamin D sterols had doses reduced to the equivalent of 2 mcg of paricalcitol three times a week or 6 mcg/week. Among the efficacy endpoints were the proportion of subjects with mean biPTH ≤160 pg/mL (∼iPTH 300 pg/mL or ng/L), with mean Ca × P ≤55 mg2/dL2 (4.4 mmol2/L2) and with both simultaneously during the assessment phase.

Results. The majority of subjects (n = 375) reached the assessment phase of the study and were included in efficacy analyses; 39 subjects withdrew due to adverse events. Sixty-two percent of subjects achieved the biPTH target, 83% achieved the Ca × P target and 54% reached both targets. Treatment reduced biPTH by 35% (P < 0.0001), calcium by 11% (P < 0.0001), phosphorus by 7% (P < 0.0001) and Ca × P by 17% (P < 0.0001). The proportion of subjects with values for biPTH, for Ca × P and for both biPTH and Ca × P within the target range during the assessment phase did not differ between subjects who received cinacalcet together with vitamin D sterols, and those who received cinacalcet alone.

Conclusion. Among subjects with moderate to severe sHPT undergoing haemodialysis, combined therapy with cinacalcet and low doses of vitamin D sterols improved achievement of the biochemical targets for CKD-MBD recommended by the KDOQI™ guidelines.

Keywords: cinacalcet; KDOQI™; PTH; secondary hyperparathyroidism; vitamin D

Journal Article.  4937 words.  Illustrated.

Subjects: Nephrology

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