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The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial.
J Clin Endocrinol Metab. 2013 Dec; 98(12):4834-44.JC

Abstract

CONTEXT

The clinical course of secondary hyperparathyroidism (sHPT) in patients on hemodialysis is not well described, and the effect of the calcimimetic cinacalcet on disease progression is uncertain.

OBJECTIVE

Our objective was to describe 1) the clinical course of sHPT in patients treated with phosphate binders and/or vitamin D sterols and 2) the impact of cinacalcet on the occurrence of severe unremitting HPT, defined by the persistence of markedly elevated PTH concentrations together with hypercalcemia or parathyroidectomy (PTX).

DESIGN AND SETTING

This was a randomized, double-blind, placebo-controlled, global, multicenter clinical trial.

PATIENTS

Of 5755 patients screened with moderate to severe sHPT, 3883 patients on hemodialysis were included in the trial.

MAIN OUTCOME MEASURES

Outcomes included PTX; severe, unremitting HPT; and use of commercial cinacalcet (a protocol violation).

INTERVENTION

Intervention was cinacalcet (30-180 mg daily) or placebo for up to 64 months.

RESULTS

In the 1935 patients randomized to placebo, 278 patients (14%) underwent PTX (median PTH 1872 pg/mL within the previous 12 weeks from surgery). Age, sex, geographic region, co-morbidity, calcium-containing phosphate binder use, and baseline serum calcium, phosphorus, and PTH concentrations were associated with PTX. Commercial cinacalcet was started in 443 (23%) patients (median PTH 1108 pg/mL before treatment began). Severe unremitting HPT developed in 470 patients (24%). In a multivariable Cox model, the relative hazard (comparing patients randomized to cinacalcet versus placebo) of severe unremitting HPT was 0.31 (95% confidence interval = 0.26-0.37). The relative hazard differed little when adjusted by baseline clinical characteristics.

CONCLUSIONS

Severe unremitting HPT develops frequently in patients on hemodialysis despite conventional therapy, and cinacalcet substantially reduces its occurrence.

Authors+Show Affiliations

MD, Health Sciences Center, Memorial University, St John's, Newfoundland, Canada A1B 3V6. pparfrey@mun.ca.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

24108314

Citation

Parfrey, Patrick S., et al. "The Clinical Course of Treated Hyperparathyroidism Among Patients Receiving Hemodialysis and the Effect of Cinacalcet: the EVOLVE Trial." The Journal of Clinical Endocrinology and Metabolism, vol. 98, no. 12, 2013, pp. 4834-44.
Parfrey PS, Chertow GM, Block GA, et al. The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial. J Clin Endocrinol Metab. 2013;98(12):4834-44.
Parfrey, P. S., Chertow, G. M., Block, G. A., Correa-Rotter, R., Drüeke, T. B., Floege, J., Herzog, C. A., London, G. M., Mahaffey, K. W., Moe, S. M., Wheeler, D. C., Dehmel, B., Trotman, M. L., Modafferi, D. M., & Goodman, W. G. (2013). The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial. The Journal of Clinical Endocrinology and Metabolism, 98(12), 4834-44. https://doi.org/10.1210/jc.2013-2975
Parfrey PS, et al. The Clinical Course of Treated Hyperparathyroidism Among Patients Receiving Hemodialysis and the Effect of Cinacalcet: the EVOLVE Trial. J Clin Endocrinol Metab. 2013;98(12):4834-44. PubMed PMID: 24108314.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The clinical course of treated hyperparathyroidism among patients receiving hemodialysis and the effect of cinacalcet: the EVOLVE trial. AU - Parfrey,Patrick S, AU - Chertow,Glenn M, AU - Block,Geoffrey A, AU - Correa-Rotter,Ricardo, AU - Drüeke,Tilman B, AU - Floege,Jürgen, AU - Herzog,Charles A, AU - London,Gerard M, AU - Mahaffey,Kenneth W, AU - Moe,Sharon M, AU - Wheeler,David C, AU - Dehmel,Bastian, AU - Trotman,Marie-Louise, AU - Modafferi,Dennis M, AU - Goodman,William G, Y1 - 2013/10/09/ PY - 2013/10/11/entrez PY - 2013/10/11/pubmed PY - 2014/4/15/medline SP - 4834 EP - 44 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 98 IS - 12 N2 - CONTEXT: The clinical course of secondary hyperparathyroidism (sHPT) in patients on hemodialysis is not well described, and the effect of the calcimimetic cinacalcet on disease progression is uncertain. OBJECTIVE: Our objective was to describe 1) the clinical course of sHPT in patients treated with phosphate binders and/or vitamin D sterols and 2) the impact of cinacalcet on the occurrence of severe unremitting HPT, defined by the persistence of markedly elevated PTH concentrations together with hypercalcemia or parathyroidectomy (PTX). DESIGN AND SETTING: This was a randomized, double-blind, placebo-controlled, global, multicenter clinical trial. PATIENTS: Of 5755 patients screened with moderate to severe sHPT, 3883 patients on hemodialysis were included in the trial. MAIN OUTCOME MEASURES: Outcomes included PTX; severe, unremitting HPT; and use of commercial cinacalcet (a protocol violation). INTERVENTION: Intervention was cinacalcet (30-180 mg daily) or placebo for up to 64 months. RESULTS: In the 1935 patients randomized to placebo, 278 patients (14%) underwent PTX (median PTH 1872 pg/mL within the previous 12 weeks from surgery). Age, sex, geographic region, co-morbidity, calcium-containing phosphate binder use, and baseline serum calcium, phosphorus, and PTH concentrations were associated with PTX. Commercial cinacalcet was started in 443 (23%) patients (median PTH 1108 pg/mL before treatment began). Severe unremitting HPT developed in 470 patients (24%). In a multivariable Cox model, the relative hazard (comparing patients randomized to cinacalcet versus placebo) of severe unremitting HPT was 0.31 (95% confidence interval = 0.26-0.37). The relative hazard differed little when adjusted by baseline clinical characteristics. CONCLUSIONS: Severe unremitting HPT develops frequently in patients on hemodialysis despite conventional therapy, and cinacalcet substantially reduces its occurrence. SN - 1945-7197 UR - https://wwww.unboundmedicine.com/medline/citation/24108314/The_clinical_course_of_treated_hyperparathyroidism_among_patients_receiving_hemodialysis_and_the_effect_of_cinacalcet:_the_EVOLVE_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2013-2975 DB - PRIME DP - Unbound Medicine ER -