Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials

In 2 RCTs (n=1023), patients randomised to iv etelcalcetide compared with placebo were significantly more likely to have a greater than 30% reduction in mean parathyroid hormone concentrations over 26 weeks (74.0% vs 8.3% and 75.3% vs 9.6%; P < 0.001 in both trials).

A related editorial discusses the finding of this study, highlighting that although it may be tempting to assume that lowering individual patients’ PTH levels by 30% to 50% or more (and simultaneously lowering serum phosphate and FGF23 levels) will result in corresponding reductions in risk, only randomised trials with hard clinical end points, including mortality, can provide clear answers.

 

Etelcalcetide activates calcium sensing receptors on parathyroid glands reducing PTH synthesis and secretion. It is licensed for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.