Etelcalcetide: What we know eight years since its approval

Abstract

Introduction and objectives

The impact of etelcalcetide on patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) has been studied since its introduction in 2016/2017. However, only a handful of studies reported clinically relevant outcomes. This narrative review aims to summarize the published data about etelcalcetide, focusing on biochemical, cardiovascular (CV) and bone endpoints, as well as adverse effects and all-cause mortality.

Materials and methods

A literature review of the use of etelcalcetide in hemodialysis patients with SHPT was conducted. Several sources were used, such as PubMed, Google Scholar and Cochrane Library.

Results

Regarding bone and mineral metabolism, etelcalcetide is effective in reducing serum levels of parathormone (PTH), calcium, phosphate and fibroblast growth factor 23 (FGF23). Preliminary data have highlighted its role in reducing bone turnover and improving mineralization and preservation of bone structure, indicating a possible positive impact on renal osteodystrophy. From a CV perspective, etelcalcetide is associated with a significant reduction in left ventricular hypertrophy. In addition, etelcalcetide reduces FGF23 and increases sclerostin serum levels. This data suggests a possible CV beneficial effect.

Conclusions

Etelcalcetide is effective in controlling SHPT. Promising data is available for some bone and surrogate cardiovascular endpoints, suggesting a possible beneficial effect. There is a lack of studies specifically designed to evaluate its role in reducing fractures, CV and all-cause mortality.