Abstract: FR-PO132
Role of Etelcalcetide in the Management of Secondary Hyperparathyroidism in Hemodialysis Patients After 10 Months of Therapy
Session Information
- Bone and Mineral Metabolism: Phosphorus, FGF23, Vascular Calcification
November 08, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Bone and Mineral Metabolism
- 402 Bone and Mineral Metabolism: Clinical
Author
- Griveas, Ioannis, Dialysis Unit "Nefroiatriki", Athens, Greece
Background
Secondary hyperparathyroidism (sHPT) is common in hemodialysis (HD) patients. The present study aimed to evaluate the efficacy and safety profile of etelcalcetide in an observational study for the treatment of SHPT in CKD patients on hemodialysis.
Methods
60 HD stable patients with sHPT were received etelcalcetide for 10 months, who were receiving oral or iv VDRA’s and/or cinacalcet or were naïve before start of the protocol. Dose of VDRA’s remained stable and adjustments to etelcalcetide dose were taken place every month. PTH levels, Ca, Ph, alb were measured before starting etelcalcetide and every month until the end of the protocol. Heart function of patients evaluated at the start and at the end of the study. The primary outcome was estimation of intact-parathyroid hormone (PTH) concentrations. Secondary outcomes were monitoring of calcium, phosphate (ph) albumin. Our study population was divided to sub-groups: a. diabetics and non-diabetics, b. patients over and below 65 years old, c. patients that were naïve regarding CKD-MBD therapy, or were receiving monotherapy or replaced cinacalcet with etelcalcetide and d. according to their previous PTH levels (below 500 pg/ml, between 500-700 pg/ml and over 700 pg/ml|). Adverse events (AEs) were also evaluated.
Results
PTH significantly decreased from the first month of the treatment with etelcalcetide (771.53±438.58 vs 586.55±497.30, p<0.05, approximately 24% reduction from baseline). This trend carried out until the end of the study period (363.08.±373.90.60, p<0.05, approximately 47% reduction from baseline).
We also noticed significant reduction of the ph levels even from the second month of treatment (from 4.98.±1.24 to 4.64±1.86 mg/dl , p<0.05). This trend also carried out for 8 months period (4.67±1.22 mg/dl, p<0,05). Heart function remained stable. In all the sub-groups we had significant reduction of PTH and Ph during the whole study period. Remarkable finding was the stable bevaviour of Ca levels from the first week until the end of the study period along with albumin. None of the patients of the protocol dropped out due to adverse events.
Conclusion
Etelcalcetide is safe, well tolerated and effective in reducing iPTH in HD s patients with sHPT. As the only available intravenous calcium-sensing
receptor agonist, etelcalcetide is likely to provide a new treatment option for sHPT in HD patients.