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Abstract: SA-PO657

Etelcalcetide in the Treatment of Secondary Hyperparathyroidism in Patients Uncontrolled with Cinacalcet – Results from a Prospective Study

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Weigert, Andre L., DaVita, Portugal, Portugal
  • Amoedo, Manuel A., DaVita, Portugal, Portugal
  • Mendes, Teresa, CHUC, Coimbra, Portugal
  • Marques, Marco Alexandre, Affidea Laboratories, Lisbon, Portugal
  • Meng, Catarina, São João Hospital Center and School of Medicine, Porto, Portugal
  • Pereira, Luciano, DaVita, Portugal, Portugal
  • Frazao, Joao M., DaVita, Portugal, Portugal
Background

Secondary hyperparathyroidism (sHPT) is associated with increased risk of fractures, vascular calcifications and all-cause mortality. Etelcalcetide is a new calcimimetic with a pharmacokinetic profile that allows thrice weekly intravenous(IV) dosing after hemodialysis(HD), recently approved for sHPT treatment. There is scarce clinical experience with this agent with respect to its efficacy in patients with sHPT that is uncontrolled with cinacalcet.

Methods

We conducted a prospective cohort study in prevalent HD patients in DaVita clinics in Portugal who had uncontrolled sHPT under cinacalcet treatment for at least 3 months. Inclusion criteria included mean intact PTH(iPTH) levels above 800 pg/mL and total calcium(Ca) above 8.3 mg/dL in the previous 3 months. After 1 week of cinacalcet washout, etelcalcetide 5mg IV/HD was initiated. iPTH, Ca and phosphorus were followed; FGF-23 and sclerostin levels were analyzed before the start of etelcalcetide and after 6 months.

Results

Thirty-four patients participated in the study; mean age was 60.7(SD ± 12.3) years; median time on HD was 82.5(7-296) months and median cinacalcet dose was 180(90-840) mg/week. Median etelcalcetide dose remained at 5mg/HD at 3 and 6 months. Evolution of biochemical parameters is represented in the figure. Over 6 months of etelcalcetide treatment, serum FGF-23 decreased from 39.3(23.0-43.3) pmol/L to 29.1(11.5 -115.6) pmol/L and sclerostin increased from 37.2(5.8 – 200.7) pmol/L to 71.7(28.2- 185.5) pmolL (p<0.0001).

Conclusion

Etelcalcetide was efficacious in improving sHPT control in this group of patients and significantly increased plasma sclerostin concentration. This is the first study describing the impact of etelcalcetide treatment on plasma sclerostin levels.