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Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism.
Nephrol Dial Transplant. 2008 Jul; 23(7):2311-8.ND

Abstract

BACKGROUND

Adequate control of all four KDOQI biochemical targets for chronic kidney disease, bone and mineral disorder (CKD-MBD), which include parathyroid hormone (PTH), calcium (Ca), phosphorus (P) and Ca x 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 x 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) (approximately 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 <or=160 pg/mL (approximately 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 <or=160 pg/mL (approximately iPTH 300 pg/mL or ng/L), with mean Ca x P <or=55 mg(2)/dL(2) (4.4 mmol(2)/L(2)) 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 x 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 x P by 17% (P < 0.0001). The proportion of subjects with values for biPTH, for Ca x P and for both biPTH and Ca x 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.

Links

Publisher Full Text (DOI)

Authors+Show Affiliations

Block GA
Denver Nephrologists, Denver, CO 80230, USA. gablock@denverneph.net
Zeig S
No affiliation info available
Sugihara J
No affiliation info available
Chertow GM
No affiliation info available
Chi EM
No affiliation info available
Turner SA
No affiliation info available
Bushinsky DA
No affiliation info available
TARGET Investigators
No affiliation info available

MeSH

AdultAgedCalciumCinacalcetDose-Response Relationship, DrugDrug Therapy, CombinationFemaleHumansHypercalcemiaHyperparathyroidism, SecondaryHyperphosphatemiaMaleMiddle AgedNaphthalenesParathyroid HormonePhosphorusSeverity of Illness IndexSterolsTreatment OutcomeVitamin D

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18310602

Clinical Trial Links

Research Study Evaluating Cinacalcet for Patients With End Stage Renal Disease (ESRD)

Citation

Block, Geoffrey A., et al. "Combined Therapy With Cinacalcet and Low Doses of Vitamin D Sterols in Patients With Moderate to Severe Secondary Hyperparathyroidism." Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, vol. 23, no. 7, 2008, pp. 2311-8.
Block GA, Zeig S, Sugihara J, et al. Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrol Dial Transplant. 2008;23(7):2311-8.
Block, G. A., Zeig, S., Sugihara, J., Chertow, G. M., Chi, E. M., Turner, S. A., & Bushinsky, D. A. (2008). Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association, 23(7), 2311-8. https://doi.org/10.1093/ndt/gfn026
Block GA, et al. Combined Therapy With Cinacalcet and Low Doses of Vitamin D Sterols in Patients With Moderate to Severe Secondary Hyperparathyroidism. Nephrol Dial Transplant. 2008;23(7):2311-8. PubMed PMID: 18310602.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. AU - Block,Geoffrey A, AU - Zeig,Steven, AU - Sugihara,Jared, AU - Chertow,Glenn M, AU - Chi,Eric M, AU - Turner,Stewart A, AU - Bushinsky,David A, AU - ,, Y1 - 2008/02/29/ PY - 2008/3/4/pubmed PY - 2008/9/25/medline PY - 2008/3/4/entrez SP - 2311 EP - 8 JF - Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association JO - Nephrol Dial Transplant VL - 23 IS - 7 N2 - BACKGROUND: Adequate control of all four KDOQI biochemical targets for chronic kidney disease, bone and mineral disorder (CKD-MBD), which include parathyroid hormone (PTH), calcium (Ca), phosphorus (P) and Ca x 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 x 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) (approximately 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 <or=160 pg/mL (approximately 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 <or=160 pg/mL (approximately iPTH 300 pg/mL or ng/L), with mean Ca x P <or=55 mg(2)/dL(2) (4.4 mmol(2)/L(2)) 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 x 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 x P by 17% (P < 0.0001). The proportion of subjects with values for biPTH, for Ca x P and for both biPTH and Ca x 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. SN - 1460-2385 UR - https://www.unboundmedicine.com/medline/citation/18310602/Combined_therapy_with_cinacalcet_and_low_doses_of_vitamin_D_sterols_in_patients_with_moderate_to_severe_secondary_hyperparathyroidism_ DB - PRIME DP - Unbound Medicine ER -