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Comment & Response
May 23/30, 2017

Dosing of Etelcalcetide and Cinacalcet for Secondary Hyperparathyroidism

Author Affiliations
  • 1Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
JAMA. 2017;317(20):2132. doi:10.1001/jama.2017.4743

To the Editor In the study by Dr Block and colleagues,1 the effect of etelcalcetide on reducing serum parathyroid hormone (PTH) levels in patients with secondary hyperparathyroidism receiving hemodialysis was compared with cinacalcet. This 26-week randomized, double-blind, double-dummy controlled trial was designed to demonstrate noninferiority between 2 calcimimetics for the primary end point of the proportion of patients achieving more than a 30% reduction in PTH levels from baseline. Demonstration of superiority on PTH reduction was a secondary end point. The authors concluded noninferiority and superiority for etelcalcetide compared with cinacalcet. However, comparative claims require a fair comparison between treatments, and the dosing algorithm in this trial appeared to favor etelcalcetide.