Comparative Effectiveness and Safety of Etelcalcetide and Cinacalcet in Hemodialysis Patients with Secondary Hyperparathyroidism: A Multicenter Retrospective Cohort Study

Abstract

Background: Etelcalcetide and cinacalcet are widely used for the treatment of secondary hyperparathyroidism (sHPT) in patients receiving maintenance hemodialysis. This study compared their real-world biochemical effectiveness and adverse-event profiles over 12 months. Methods: This multicenter retrospective cohort study included 116 hemodialysis patients with sHPT treated at five dialysis centers. Sixty-three patients received intravenous etelcalcetide and 53 received oral cinacalcet. The primary outcome was the between-group difference in the percentage change in parathyroid hormone (PTH) from baseline to 12 months. Secondary outcomes included longitudinal changes in corrected calcium, phosphorus, albumin, and C-reactive protein levels and the incidence of treatment-related adverse events. Results: Baseline PTH levels were higher in the etelcalcetide group than in the cinacalcet group (1562 vs. 1268 pg/mL, p = 0.011). PTH levels decreased during the first 3 months and subsequently fluctuated in both groups. The mean 12-month percentage change in PTH was −17.52% in the cinacalcet group and −14.13% in the etelcalcetide group (between-group mean difference, 3.39 percentage points; 95% CI, −20.36 to 27.14; p = 0.776). Hypocalcemia occurred more frequently with etelcalcetide than with cinacalcet (52% vs. 32%, p = 0.028). In contrast, nausea (68% vs. 2%, p = 0.001) and vomiting (8% vs. 0%, p = 0.026) were more frequent with cinacalcet. Conclusions: No statistically significant difference in the 12-month percentage change in PTH was observed between etelcalcetide and cinacalcet, although baseline PTH levels were higher in the etelcalcetide group. The treatments demonstrated distinct adverse-event profiles, with more frequent hypocalcemia during etelcalcetide treatment and more frequent gastrointestinal adverse events during cinacalcet treatment. These findings describe biochemical outcomes and adverse-event frequencies among patients who remained on treatment for at least 3 months; they do not establish therapeutic equivalence or comparative safety.