Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis
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...
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doaj-106049a49b9c484d954b1044538922722020-12-08T07:41:34ZengNature Publishing GroupScientific Reports2045-23222019-04-019111110.1038/s41598-019-42017-zLong-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving HemodialysisKeitaro Yokoyama0Ryutaro Shimazaki1Masafumi Fukagawa2Tadao Akizawa3On behalf of Evocalcet Study GroupDivision of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of MedicineR&D Division, Kyowa Hakko Kirin Co., Ltd.Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of MedicineDivision of Nephrology, Department of Medicine, Showa University School of MedicineAbstract 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.https://doi.org/10.1038/s41598-019-42017-z |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Keitaro Yokoyama Ryutaro Shimazaki Masafumi Fukagawa Tadao Akizawa On behalf of Evocalcet Study Group |
spellingShingle |
Keitaro Yokoyama Ryutaro Shimazaki Masafumi Fukagawa Tadao Akizawa On behalf of Evocalcet Study Group Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis Scientific Reports |
author_facet |
Keitaro Yokoyama Ryutaro Shimazaki Masafumi Fukagawa Tadao Akizawa On behalf of Evocalcet Study Group |
author_sort |
Keitaro Yokoyama |
title |
Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis |
title_short |
Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis |
title_full |
Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis |
title_fullStr |
Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis |
title_full_unstemmed |
Long-Term Efficacy and Safety of Evocalcet in Japanese Patients with Secondary Hyperparathyroidism Receiving Hemodialysis |
title_sort |
long-term efficacy and safety of evocalcet in japanese patients with secondary hyperparathyroidism receiving hemodialysis |
publisher |
Nature Publishing Group |
series |
Scientific Reports |
issn |
2045-2322 |
publishDate |
2019-04-01 |
description |
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. |
url |
https://doi.org/10.1038/s41598-019-42017-z |
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