Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients
Abstract Background Cinacalcet hydrochloride (cinacalcet), an oral calcimimetics for secondary hyperparathyroidism (SHPT), has been widely used worldwide. In contrast, evocalcet, an improved derivative of cinacalcet, was approved only in Japan in 2018 and has not received approval overseas. Conseque...
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | Renal Replacement Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41100-024-00529-z |
| _version_ | 1797273158300991488 |
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| author | Nobuo Nagano Takayuki Ishikawa Masashi Yamaguchi Yuji Katsuragi Masaaki Miya Noriko Tamei Shigeaki Muto Takaaki Tsutsui Tetsuya Ogawa Kyoko Ito |
| author_facet | Nobuo Nagano Takayuki Ishikawa Masashi Yamaguchi Yuji Katsuragi Masaaki Miya Noriko Tamei Shigeaki Muto Takaaki Tsutsui Tetsuya Ogawa Kyoko Ito |
| author_sort | Nobuo Nagano |
| collection | DOAJ |
| description | Abstract Background Cinacalcet hydrochloride (cinacalcet), an oral calcimimetics for secondary hyperparathyroidism (SHPT), has been widely used worldwide. In contrast, evocalcet, an improved derivative of cinacalcet, was approved only in Japan in 2018 and has not received approval overseas. Consequently, the available information on the long-term use of evocalcet relies solely on data from a 1-year dosing phase III clinical trial. Methods The cohort of 147 chronic hemodialysis patients on cinacalcet to manage SHPT was simultaneously switched to the lowest dose of evocalcet (1 mg/day) and prospectively followed for 5 years in real-world clinical settings. Results The median evocalcet dose was 1 mg/day at 0.5 years, and it remained stable at 2 mg/day from 1 to 5 years after the prescription initiation. Additionally, serum parathyroid hormone, corrected calcium, phosphorus, and total alkaline phosphatase levels showed no significant changes compared with their levels at the time of the switch and remained stable over the 5-year period. Furthermore, no adverse events related to vital signs, serum biochemistries, or upper gastrointestinal symptoms were observed in patients during treatment with evocalcet. Conclusions These results suggest that only a small number of patients require higher evocalcet doses, and that SHPT can be effectively managed with low-dose evocalcet for 5 years. Additionally, the drug’s long-term safety has been confirmed. Trial registration: name of the registry: Prescription change from cinacalcet hydrochloride to evocalcet in hemodialysis patients. Trial registration number R000041815. Trial registration UMIN000036702. Registered 10 May 2019—retrospectively registered. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000041815 . |
| first_indexed | 2024-03-07T14:39:35Z |
| format | Article |
| id | doaj.art-4241806a714041298f3194bb1fc8cb9c |
| institution | Directory Open Access Journal |
| issn | 2059-1381 |
| language | English |
| last_indexed | 2024-03-07T14:39:35Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Renal Replacement Therapy |
| spelling | doaj.art-4241806a714041298f3194bb1fc8cb9c2024-03-05T20:25:18ZengBMCRenal Replacement Therapy2059-13812024-03-011011710.1186/s41100-024-00529-zLong-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patientsNobuo Nagano0Takayuki Ishikawa1Masashi Yamaguchi2Yuji Katsuragi3Masaaki Miya4Noriko Tamei5Shigeaki Muto6Takaaki Tsutsui7Tetsuya Ogawa8Kyoko Ito9Kidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalKidney Disease and Dialysis Center, Hidaka HospitalAbstract Background Cinacalcet hydrochloride (cinacalcet), an oral calcimimetics for secondary hyperparathyroidism (SHPT), has been widely used worldwide. In contrast, evocalcet, an improved derivative of cinacalcet, was approved only in Japan in 2018 and has not received approval overseas. Consequently, the available information on the long-term use of evocalcet relies solely on data from a 1-year dosing phase III clinical trial. Methods The cohort of 147 chronic hemodialysis patients on cinacalcet to manage SHPT was simultaneously switched to the lowest dose of evocalcet (1 mg/day) and prospectively followed for 5 years in real-world clinical settings. Results The median evocalcet dose was 1 mg/day at 0.5 years, and it remained stable at 2 mg/day from 1 to 5 years after the prescription initiation. Additionally, serum parathyroid hormone, corrected calcium, phosphorus, and total alkaline phosphatase levels showed no significant changes compared with their levels at the time of the switch and remained stable over the 5-year period. Furthermore, no adverse events related to vital signs, serum biochemistries, or upper gastrointestinal symptoms were observed in patients during treatment with evocalcet. Conclusions These results suggest that only a small number of patients require higher evocalcet doses, and that SHPT can be effectively managed with low-dose evocalcet for 5 years. Additionally, the drug’s long-term safety has been confirmed. Trial registration: name of the registry: Prescription change from cinacalcet hydrochloride to evocalcet in hemodialysis patients. Trial registration number R000041815. Trial registration UMIN000036702. Registered 10 May 2019—retrospectively registered. https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_his_list.cgi?recptno=R000041815 .https://doi.org/10.1186/s41100-024-00529-zSecondary hyperparathyroidismEvocalcetCinacalcet hydrochlorideEvocalcet dosageSerum parathyroid hormone levels |
| spellingShingle | Nobuo Nagano Takayuki Ishikawa Masashi Yamaguchi Yuji Katsuragi Masaaki Miya Noriko Tamei Shigeaki Muto Takaaki Tsutsui Tetsuya Ogawa Kyoko Ito Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients Renal Replacement Therapy Secondary hyperparathyroidism Evocalcet Cinacalcet hydrochloride Evocalcet dosage Serum parathyroid hormone levels |
| title | Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients |
| title_full | Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients |
| title_fullStr | Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients |
| title_full_unstemmed | Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients |
| title_short | Long-term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism: a five-year prospective cohort study in 147 Japanese patients |
| title_sort | long term treatment of evocalcet in hemodialysis patients with secondary hyperparathyroidism a five year prospective cohort study in 147 japanese patients |
| topic | Secondary hyperparathyroidism Evocalcet Cinacalcet hydrochloride Evocalcet dosage Serum parathyroid hormone levels |
| url | https://doi.org/10.1186/s41100-024-00529-z |
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