Abstract
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 n = 1190 patients on the charge. From this cohort, n = 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.
Highlights
Secondary hyperparathyroidism (SHPT) is frequent in patients on dialysis.Pathogenesis of SHPT is multifactorial; several therapeutic strategies have to be utilized to reduce serum levels of parathyroid hormone (PTH), such as calcitriol, oral and IV vitamin D analogs, phosphate binders, and calcimimetic cinacalcet.For many years, cinacalcet, the unique calcimimetic available, has been regarded as the preferred option for the subgroup of patients with SHPT characterized by hypercalcemia, or with SHPT refractory to calcitriol or active vitamin D analogs.Recent guidelines do not prioritize any medication, but they suggest calcimimetic, calcitriol, or vitamin D analogs, or a combination of calcimimetic with calcitriol or vitamin D analogs in patients on dialysis with SHPT [1]
Etelcalcetide was administered to naïve patients with SHPT and to patients who were on treatment with cinacalcet; in the latter condition, etelcalcetide was administered as replacement medication either to obtain a better control of serum levels of PTH and to reduce side effects or pills burden
N = 168 (14%) patients were on treatment with etelcalcetide, and they were evaluated for statistics
Summary
Secondary hyperparathyroidism (SHPT) is frequent in patients on dialysis.Pathogenesis of SHPT is multifactorial; several therapeutic strategies have to be utilized to reduce serum levels of parathyroid hormone (PTH), such as calcitriol, oral and IV vitamin D analogs, phosphate binders, and calcimimetic cinacalcet.For many years, cinacalcet, the unique calcimimetic available, has been regarded as the preferred option for the subgroup of patients with SHPT characterized by hypercalcemia, or with SHPT refractory to calcitriol or active vitamin D analogs.Recent guidelines do not prioritize any medication, but they suggest calcimimetic, calcitriol, or vitamin D analogs, or a combination of calcimimetic with calcitriol or vitamin D analogs in patients on dialysis with SHPT [1]. Secondary hyperparathyroidism (SHPT) is frequent in patients on dialysis. Pathogenesis of SHPT is multifactorial; several therapeutic strategies have to be utilized to reduce serum levels of parathyroid hormone (PTH), such as calcitriol, oral and IV vitamin D analogs, phosphate binders, and calcimimetic cinacalcet. Cinacalcet, the unique calcimimetic available, has been regarded as the preferred option for the subgroup of patients with SHPT characterized by hypercalcemia, or with SHPT refractory to calcitriol or active vitamin D analogs. Recent guidelines do not prioritize any medication, but they suggest calcimimetic, calcitriol, or vitamin D analogs, or a combination of calcimimetic with calcitriol or vitamin D analogs in patients on dialysis with SHPT [1]. The efficacy of etelcalcetide in reducing levels of PTH has been ascertained in randomized controlled trials (RCTs) [2,3]. No data are available on the effectiveness and safety of etelcalcetide in everyday clinical practice
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