Ioannis Griveas
NEFROIATRIKI Ltd., Greece
Title: Efficacy and safety of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism: Real life data
Biography
Biography: Ioannis Griveas
Abstract
Secondary hyperparathyroidism (SHPT), complication of chronic kidney disease, is characterized by disturbances in mineral metabolism. Calcium-sensing receptor (CaSR) is the main physiological regulator of parathyroid hormone (PTH) secretion. We tried to evaluate efficacy and safety of etelcalcetide, a new IV calcimimetic in our hemodialysis (HD) population. We prospectively followed 60 HD patients for a six month period. The primary endpoint of the study was the proportion of patients with serum intact parathyroid hormone (iPTH) between 200-350 pg/ml until the end of the study period. The following parameters were determined as secondary efficacy endpoints: measured and percent changes from baseline in serum iPTH, Ca, pH, Alb, Hct, Hb, SAP, cardiac function at each time point. The safety and tolerability profiles of etelcalcetide were assessed based on AEs (Advanced Encryption Standard). After a month of treatment with etelcalcetide, PTH reduced significantly from 823 pg/mils to 654.8 pg/mils (p<0.05). pH levels were also significantly reduced from 7.28 to 5.04 mg/dl (p<0.05). Ca levels remained stable after a week of therapy (from 8.68 mg/dl to 8.61 mg/dl, p=NS). In five patients Ca levels were below 7.5 mg/dl. In three of them Ca levels returned to baseline after a month, in one dose of etelcalcetide reduced, and one had to stop medication temporarily. None of our patients had GI adverse effects. After 2 months notification, the new second-generation calcimimetic etelcalcetide effectively reduces PTH, pH with an acceptable safety profile. Hopefully at the end of our study protocol we will reach to more solid conclusions regarding better control of SHPT.