Dosing of Etelcalcetide vs Cinacalcet for Secondary Hyperparathyroidism—Reply

• Autores: Geoffrey A. Block, Glenn M. Chertow
• Localización: JAMA: the journal of the American Medical Association, ISSN 0098-7484, Vol. 317, Nº. 20, 2017, págs. 2132-2133
• Idioma: inglés
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• Resumen

  • In Reply Dr Hai and colleagues are concerned that the starting dose of etelcalcetide was 5 mg (not the lowest dose) whereas the starting dose of cinacalcet was 30 mg (the lowest dose). This clinical trial, using a double-dummy active control, dosed cinacalcet in strict accordance with the approved package insert and in a manner consistent with previous clinical trials of similar duration using similar biochemical end points.1,2 Our finding of a mean decrease in PTH of approximately 40% over 26 weeks in patients treated with cinacalcet is similar to findings of the phase 3 trials with cinacalcet (43% decrease in mean PTH over 26 weeks).1 The dosing of etelcalcetide was approved by the US Food and Drug Administration. Because cinacalcet and etelcalcetide are different drugs, there is no a priori reason to believe that their dosing schemes should be identical.