The efficacy and safety of evocalcet in hemodialysis patients

Abstract

Cinacalcet hydrochloride (cinacalcet) is a useful treatment for secondary hyperparathyroidism, but it causes upper gastrointestinal symptoms at a relatively high frequency. Compared with cinacalcet, evocalcet exhibits an improved upper gastrointestinal symptom and drug interaction profile. In this study, we investigated the efficacy and safety of evocalcet in outpatients undergoing maintenance hemodialysis who developed secondary hyperparathyroidism at our hospital, including 57 patients who received ≤50 mg/day cinacalcet before switching to evocalcet. The observation period was 12 weeks from the initiation of evocalcet treatment between June 2018 and September 2018. The target intact parathyroid hormone (iPTH) level was 60-240 pg/mL, and the doses of evocalcet and a vitamin D (VitD) preparation were adjusted based on the corrected serum calcium level. The starting dose of evocalcet was 1 mg/day. The evocalcet dose was increased by 1 mg at intervals of at least 2 weeks. After 12 weeks, 42.1% of patients were receiving 1 mg evocalcet, and 49.1% of patients were receiving 2-4 mg evocalcet. A VitD preparation was added or the VitD preparation dose was increased in 5.3% of patients. iPTH levels of ≤240 pg/mL were seen in 71.9% of cases at the baseline, 49.1% after 1 week, and 64.9% after 12 weeks, and the iPTH levels of patients who switched from ≥37.5 mg/day cinacalcet decreased. Of 5 patients who experienced adverse upper gastrointestinal reactions while receiving oral cinacalcet, none of them exhibited symptoms while taking evocalcet. Only two patients developed novel symptoms while receiving oral evocalcet, and only one patient developed a corrected serum calcium level of ≤7.5 mg/dL. In this study, evocalcet was considered to be useful in terms of both its efficacy and safety, although the iPTH level increased after the medication switch in some patients who had been treated with 50 mg/day cinacalcet.