Etelcalcetide in Patients on Hemodialysis with Severe Secondary Hyperparathyroidism. Multicenter Study in "Real Life".
Domenico Russo, Rocco Tripepi, Fabio Malberti, Biagio Di Iorio, Bernadette Scognamiglio, Luca Di Lullo, Immacolata Gaia Paduano, Giovanni Luigi Tripepi, Vincenzo Antonio Panuccio
Author Information
Domenico Russo: Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy. domenicorusso51@hotmail.com.
Rocco Tripepi: Institute of Clinical Physiology (IFC-CNR) Research Unit of Reggio Calabria, 89124 Reggio Calabria, Italy.
Fabio Malberti: Department of Nephrology Cremona Hospital, 26100 Cremona, Italy.
Biagio Di Iorio: Department of Nephrology AORN Cardarelli, 80131 Naples, Italy.
Bernadette Scognamiglio: Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy.
Luca Di Lullo: Department of Nephrology Ospedale "Parodi Delfino" di Colleferro (Roma), 00034 Colleferro, Roma, Italy.
Immacolata Gaia Paduano: Department of Public Health, University of Naples FEDERICO II, 80131 Naples, Italy.
Giovanni Luigi Tripepi: Institute of Clinical Physiology (IFC-CNR) Research Unit of Reggio Calabria, 89124 Reggio Calabria, Italy.
Vincenzo Antonio Panuccio: Nephrology, Dialysis and transplantation Unit G.O.M. "Bianchi Melacrino Morelli", 89121 Reggio Calabria, Italy.
Etelcalcetide is a new calcimimetic indicated for the treatment of secondary hyperparathyroidism (SHPT) in dialysis patients. Etelcalcetide efficacy in SHPT has been ascertained only in randomized controlled trials. This multicenter study was carried out in "real world" setting that is different from randomized controlled trials (RCTs) to (1) evaluate the effectiveness of etelcalcetide in SHPT, (2) to assess calcium, phosphorus, alkaline phosphatase changes, (3) to register gastrointestinal side effects. Data were collected from twenty-three dialysis units with = 1190 patients on the charge. From this cohort, = 168 (14%) patients were on treatment with etelcalcetide, and they were evaluated for statistics. A median weekly dose of etelcalcetide was 15 mg (7.5-45 mg). Patients were either naïve (33%) or switched from cinacalcet to obtain better control of SHPT with reduced side effects or pills burden. Serum parathyroid hormone (PTH) declined over time from a median value of 636 pg/mL to 357 pg/mL. The median time for responders (intact PTH (iPTH) range: two to nine times the upper normal limit) was 53 days; the percentage of responders increased (from baseline 27% to 63%) being similar in switched-patients and naïve-patients. Few patients had symptomatic hypocalcemia requiring etelcalcetide withdrawal (four cases (3%) at 30-day control, two cases (2%) at 60-day, one case (1%) at 90-day control). Side effects with etelcalcetide were lower (3-4%) than that registered during cinacalcet treatment (53%). Etelcalcetide is a new therapeutic option for SHPT with low side effects and pills burden. Etelcalcetide may improve adherence to therapy, avoiding unremitting SHP. It remains to be assessed whether etelcalcetide may reduce parathyroidectomy, vascular calcification, or mortality. Being etelcalcetide very potent in suppressing PTH levels, even in severe SHPT, future studies should evaluate the potential risk of more adynamic bone disease during long-term therapy.
