Abstract
Secondary hyperparathyroidism (SHPT) is a common complication of chronic kidney disease (CKD), and as the disease progresses SHPT is associated with systemic consequences, termed CKD-mineral and bone disorder. Currently, cinacalcet is indicated for the treatment of SHPT; however, cinacalcet is associated with upper gastrointestinal adverse events. Evocalcet has been developed to address these issues, but the long-term safety and efficacy of evocalcet need to be evaluated. To more accurately reflect clinical practice, this phase 3, multicenter, open-label study was specifically designed without a cinacalcet washout period, and focused on those patients who switched from cinacalcet to evocalcet. A total of 137 SHPT patients undergoing hemodialysis were enrolled, of whom 113 switched from cinacalcet to evocalcet. The most frequent type of adverse drug reaction was decreased adjusted calcium. The incidence of gastrointestinal-related adverse events did not increase in a dose-dependent manner as the dose of evocalcet was increased. The percentage of patients achieving the target intact parathyroid hormone concentration increased from 40.9% to 72.3% with 52-week treatment. The corrected serum calcium and phosphorus levels remained largely unchanged throughout the study. The long-term safety and efficacy of evocalcet was confirmed using a clinically relevant intra-subject dose-adjustment strategy in SHPT patients undergoing hemodialysis.
Highlights
Evocalcet is a novel calcimimetic developed as an efficacious, but more tolerable, alternative to the currently available calcimimetics for Secondary hyperparathyroidism (SHPT) patients
A 30-week phase 3 study indicated that 1–8 mg of evocalcet was non-inferior to cinacalcet, with approximately 70% of patients showing improvement in intact PTH levels while reporting fewer GI adverse events[14]
These results were not inferior to the guidelines set by The Japanese Society for Dialysis Therapy (JSDT) for the management of SHPT in HD patients[15]
Summary
Evocalcet is a novel calcimimetic developed as an efficacious, but more tolerable, alternative to the currently available calcimimetics for SHPT patients. In pre-clinical studies, evocalcet demonstrated efficacy in www.nature.com/scientificreports/. A 30-week phase 3 study indicated that 1–8 mg of evocalcet was non-inferior to cinacalcet, with approximately 70% of patients showing improvement in intact PTH (iPTH) levels while reporting fewer GI adverse events[14]. These results were not inferior to the guidelines set by The Japanese Society for Dialysis Therapy (JSDT) for the management of SHPT in HD patients[15]. The current 52-week phase 3 study examined the long-term safety and efficacy of once-daily oral administration of 1–12 mg evocalcet in SHPT patients undergoing HD. Patients who were currently receiving cinacalcet were switched to evocalcet so as to accurately reflect the clinical setting
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