FP596
EFFICACY AND SAFETY OF ETELCALCETIDE IN HEMODIALYSIS PATIENTS WITH SECONDARY HYPERPARATHYROIDISM INADEQUATELY CONTROLLED WITH CINACALCET Free

INTRODUCTION AND AIMS: The oral calcimimetic cinacalcet is effective in treating secondary hyperparathyroidism (SHPT), but its use has been limited by a relatively high frequency of gastrointestinal adverse effects. The aim of this study was to examine the efficacy and safety of the IV calcimimetic etelcalcetide in hemodialysis patients with SHPT inadequately controlled with cinacalcet.

METHODS: We undertook a 24-wk, open-label clinical trial in 20 hemodialysis patients who were receiving cinacalcet and had inadequately controlled SHPT (intact PTH >300 pg/ml). Patients were switched from cinacalcet to etelcalcetide and received concurrent treatment with IV calcitriol. The doses of etelcalcetide were titrated to achieve intact PTH levels between 60 and 240 pg/ml. The primary end point was the percentage of patients with values in this range during weeks 20 to 24.

RESULTS: At the screening phase, the mean cinacalcet daily dose was 41 mg and no patients received the maximal dose of 100 mg. Reasons for the limited dose escalation were gastrointestinal adverse effects (40%) and poor adherence (60%). Ninety-five percent (19 of 20) of patients reached the assessment phase and no patients withdrew due to adverse events. The intact PTH target was achieved in 63% (12 of 19) of patients. Serum calcium levels were well controlled by means of adjustments in the doses of calcium carbonate and IV calcitriol. There were no gastrointestinal adverse effects and symptomatic hypocalcemia during the study.

CONCLUSIONS: Etelcalcetide is effective and well tolerated in hemodialysis patients with SHPT inadequately controlled with cinacalcet. Our results support etelcalcetide as a potential therapeutic option for patients in whom further dose escalation of cinacalcet is limited by gastrointestinal adverse effects or poor adherence.