Etelcalcetid (1) – Parsabiv®

• Clinical trials
  • To assess the additional benefit of etelcalcetide compared with cinacalcet, the pharmaceutical manufacturer has submitted study 20120360. The randomised, double-blind, double-dummy trial included adults on haemodialysis with chronic renal insufficiency suffering from secondary hyperparathyroidism (sHPT), in which Etelcalcetid was compared with Cinacalcet.

Secondary hyperparathyroidism in adults with chronic renal insufficiency requiring dialysis

• An additional benefit is not proven.
• Consequently, on balance, there is no additional benefit for etelcalcetide compared with the appropriate comparator therapy, cinacalcet.
• mortality
  • Deaths were recorded only as part of the assessment of AE. No statistically significant differences were observed. No advantage or disadvantage for etelcalcetide can be inferred from these results with regard to overall survival.
• Morbidity – Nausea and vomiting
  • In principle, the occurrence of nausea and vomiting is clinically relevant.
  • No statistically significant difference was observed between the treatment groups for any of the three reported measures (days with nausea and vomiting, episodes of vomiting, severity of nausea). Consequently, no additional benefit for Etelcalcetid over the appropriate comparator therapy, cinacalcet, can be inferred with regard to the symptoms of nausea and vomiting.
• Morbidity – PTH reduction
  • The PTH level is a laboratory parameter and is therefore regarded as a surrogate marker.
  • The pharmaceutical manufacturer has not provided data to validate whether the reduction in PTH levels translates to patient-relevant endpoints regarding the long-term consequences of secondary hyperparathyroidism, such as bone pain and fractures, as well as cardiovascular complications. Consequently, the endpoint is considered not to be patient-relevant and is not used in the assessment of the additional benefit of etelcalcetide.
• health-related quality of life
  • No usable data are available for the assessment of quality of life.

Courtesy translation only, please refer to the German original.