Etelcalcetide controls secondary hyperparathyroidism and raises sclerostin levels in hemodialysis patients previously uncontrolled with cinacalcet / Etelcalcetida controla el hiperparatiroidismo secundario y eleva los niveles de esclerostina en pacientes en hemodiálisis previamente no controlados con cinacalcet

Introduction: There is scarce clinical experience with etelcalcetide in patients with secondary hyperparathyroidism uncontrolled with cinacalcet. The effect of etelcalcetide on serum sclerostin levels remains to be clarified. Materials and methods: Prospective cohort study in prevalent hemodialysis patients with uncontrolled sHPT under cinacalcet for at least 3 months, mean parathyroid hormone (PTH)>800pg/mL and calcium (Ca)>8.3mg/dL. Etelcalcetide 5mg IV/HD was initiated after cinacalcet washout. Levels of PTH, Ca, and phosphorus (Pi) followed monthly for 6 months. Plasma sclerostin levels measured before etelcalcetide treatment and after 6 months. Results: Thirty-four patients were enrolled, 19 (55.9%) male gender. Mean age 60.7 (± 12.3) years; median time on HD 82.5 (7–296) months and median cinacalcet dose was 180mg/week (Interquartile Range: 180–270). Serum Ca, Pi and PTH levels showed a significant reduction after etelcalcetide treatment from 8.8mg/dL, 5.4mg/dL and 1005pg/mL to 8.1mg/dL (p=0.08), 4.9mg/dL (p=0.01) and 702pg/mL (p<0.001), respectively. Median etelcalcetide dose remained at 5mg/HD. Plasma sclerostin concentration increased from 35.66pmol/L (IQR11.94–54.58) to 71.05pmol/L (IQR54.43–84.91) (p<0.0001). Conclusion: Etelcalcetide improved sHPT control in this group of patients, previously under cinacalcet treatment, and significantly increased plasma sclerostin concentration. The impact of etelcalcetide treatment on sclerostin levels is a novel finding. (AU)

Introducción: Existe escasa experiencia clínica sobre el uso de etelcalcetida en pacientes con hiperparatiroidismo secundario no controlado con cinacalcet. Asimismo, el efecto de la etelcalcetida sobre los niveles de esclerostina aún no ha sido aclarado. Materiales y métodos: Realizamos un estudio de cohorte prospectivo en pacientes en hemodiálisis (HD) con hiperparatiroidismo secundario no controlado con cinacalcet durante al menos 3 meses, hormona paratiroidea media> 800 pg/ml y calcio (Ca)> 8,3mg/dl. Tras un periodo de lavado, se inició administración intravenosa de etelcalcetida 5mg/HD y se realizó un seguimiento mensual de los niveles de hormona paratiroidea, Ca y fósforo (Pi) durante 6 meses. Además, los niveles de esclerostina plasmática fueron medidos antes del tratamiento con etelcalcetida y después de 6 meses. Resultados: Se incluyeron 34 pacientes, 19 (55,9%) de sexo masculino. Edad media 60,7±12,3 años; la mediana de tiempo en HD fue 82,5 (7-296) meses y la mediana de la dosis de cinacalcet fue de 180mg/semana (rango intercuartílico 180-270). Los niveles séricos de Ca, Pi y hormona paratiroidea mostraron una reducción significativa después del tratamiento con etelcalcetida desde 8,8mg/dl, 5,4mg/dl y 1005 pg/ml hasta 8,1mg/dl (p=0,08), 4,9mg/dl (p=0,01) y 702 pg/mL (p<0,001) respectivamente. La dosis media de etelcalcetida se mantuvo en 5mg/HD. La concentración de esclerostina plasmática aumentó de 35,66pmol/L (rango intercuartílico 11,94-54,58) a 71,05pmol/L (rango intercuartílico 54,43-84,91; p <0,0001). Conclusión: En este grupo de pacientes previamente en tratamiento con cinacalcet, la etelcalcetida mejoró el control de hiperparatiroidismo secundario y resultó en un aumento de la concentración plasmática de esclerostina. El efecto del tratamiento con etelcalcetida sobre los niveles de esclerostina es un hallazgo novedoso. (AU)

Etelcalcetide controls secondary hyperparathyroidism and raises sclerostin levels in hemodialysis patients previously uncontrolled with cinacalcet.

INTRODUCTION: There is scarce clinical experience with etelcalcetide in patients with secondary hyperparathyroidism uncontrolled with cinacalcet. The effect of etelcalcetide on serum sclerostin levels remains to be clarified. MATERIALS AND METHODS: Prospective cohort study in prevalent hemodialysis patients with uncontrolled sHPT under cinacalcet for at least 3 months, mean parathyroid hormone (PTH)>800pg/mL and calcium (Ca)>8.3mg/dL. Etelcalcetide 5mg IV/HD was initiated after cinacalcet washout. Levels of PTH, Ca, and phosphorus (Pi) followed monthly for 6 months. Plasma sclerostin levels measured before etelcalcetide treatment and after 6 months. RESULTS: Thirty-four patients were enrolled, 19 (55.9%) male gender. Mean age 60.7 (± 12.3) years; median time on HD 82.5 (7-296) months and median cinacalcet dose was 180mg/week (Interquartile Range: 180-270). Serum Ca, Pi and PTH levels showed a significant reduction after etelcalcetide treatment from 8.8mg/dL, 5.4mg/dL and 1005pg/mL to 8.1mg/dL (p=0.08), 4.9mg/dL (p=0.01) and 702pg/mL (p<0.001), respectively. Median etelcalcetide dose remained at 5mg/HD. Plasma sclerostin concentration increased from 35.66pmol/L (IQR11.94-54.58) to 71.05pmol/L (IQR54.43-84.91) (p<0.0001). CONCLUSION: Etelcalcetide improved sHPT control in this group of patients, previously under cinacalcet treatment, and significantly increased plasma sclerostin concentration. The impact of etelcalcetide treatment on sclerostin levels is a novel finding.