Kidney Research and Clinical Practice  
Long-term effectiveness of cinacalcet in non-dialysis patients with chronic kidney disease and secondary hyperparathyroidism
Ariadna Pérez-Ricart1 , Maria Galicia-Basart2 , Dolors Comas-Sugrañes3, Josep-Maria Cruzado-Garrit4, Alfons Segarra-Medrano5 , José-Bruno Montoro-Ronsano1
Correspondence to: José-Bruno Montoro-Ronsano
Servei de Farmàcia, Àrea General, Hospital Universitari Vall d’Hebron, Passeig Vall d’Hebron 119-129, Barcelona 08035, Spain. E-mail: bmontoro@vhebron.net
Ariadna Pérez-Ricart’s current affiliation: Pharmacy Department, Hospital Nostra Senyora de Meritxell, Escaldes-Engordany, Principat d'Andorra.
Received: August 1, 2018; Revised: November 25, 2018; Accepted: December 18, 2018; Published online: April 25, 2019.
© The Korean Society of Nephrology. All rights reserved.

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/ licenses/by-nc-nd/4.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Background: Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD). Cinacalcet use is controversial in non-dialysis patients.
Methods: This retrospective observational study recruited patients receiving cinacalcet (off-label use) in 2010 and 2011. Patients were followed for three years from the beginning of treatment using an intention-to-treat approach.
Results: Forty-one patients were studied: 14 CKD stage 3 (34.1%), 21 CKD stage 4 (51.2%), and 6 CKD stage 5 (14.6%). Median baseline parathyroid hormone (PTH) was 396 (101-1,300) pg/mL. Upon cinacalcet treatment (22 ± 12 months), PTH levels decreased by ≥ 30% in 73.2% of patients ( P < 0.001; 95% confidence interval [CI], 59-87%), with a mean time for response of 18.7 months (95% CI, 15.4-22.1). Sixteen patients were followed for 36 months and treated for 32 ± 9 months. Mean reduction in their PTH levels was 50.1% ( P < 0.001; 95% CI, 33.8-66.4%) at 36 months, with 62.5% of patients ( P < 0.001; 95% CI, 35.9-89.1%) presenting reductions of ≥ 30%. Serum calcium levels decreased from 9.95 ± 0.62 mg/dL to 9.21 ± 0.83 and 9.12 ± 0.78 mg/dL at 12 and 36 months, respectively ( P < 0.001). Serum phosphorus levels increased from 3.59 ± 0.43 to 3.82 ± 0.84 at 12 months ( P = 0.180), remaining so at 36 months ( P = 0.324). At 12 and 36 months, 2 (12.5%) patients experienced hypocalcemia. Meanwhile, 1 (6.3%) and 4 (25.0%) patients reported hyperphosphatemia at 12 and 36 months, respectively.
Conclusions: Cinacalcet remained effective for at least 36 months in non-dialysis patients with SHPT. Electrolytic disturbances were managed with concurrent use of vitamin D and its analogs or phosphate binders.
Keywords: Chronic renal insufficiency, Cinacalcet, Parathyroid hormone, Secondary hyperparathyroidism


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