The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism
Background: Secondary hyperparathyroidism (SHPT) is associated with high incidences of cardiovascular disease, bone fracture, and mortality. This study was conducted to demonstrate the effectiveness of cinacalcet treatment on chronic kidney disease-mineral bone disorder (CKD-MBD) markers in chronic...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2019-01-01
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| Series: | Renal Failure |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/0886022X.2018.1562356 |
| _version_ | 1818436860294201344 |
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| author | Paweena Susantitaphong Somratai Vadcharavivad Teerada Susomboon Wanchana Singhan Netsiri Dumrongpisutikul Ketsuda Jakchairoongruang Somchai Eiam-Ong Kearkiat Praditpornsilpa |
| author_facet | Paweena Susantitaphong Somratai Vadcharavivad Teerada Susomboon Wanchana Singhan Netsiri Dumrongpisutikul Ketsuda Jakchairoongruang Somchai Eiam-Ong Kearkiat Praditpornsilpa |
| author_sort | Paweena Susantitaphong |
| collection | DOAJ |
| description | Background: Secondary hyperparathyroidism (SHPT) is associated with high incidences of cardiovascular disease, bone fracture, and mortality. This study was conducted to demonstrate the effectiveness of cinacalcet treatment on chronic kidney disease-mineral bone disorder (CKD-MBD) markers in chronic hemodialysis patients with severe SHPT. Methods: In phase 1, 30 adult HD patients were randomized to cinacalcet or control groups for 12 weeks to explore the achievement of >30% reduction of iPTH. In phase 2, 45 patients were participated to further explore the effect of cinacalcet on CKD-MBD parameters for 24-week follow up and 12 additional weeks after cinacalcet discontinuation. Results: In phase 1, the baseline serum iPTH levels were not different [1374 (955, 1639) pg/mL in the control group vs. 1191 (1005, 1884) pg/mL in the cinacalcet group], the percentage of patients achieving iPTH target were significantly higher in the treatment group [80% vs. 13%, p = .001]. In phase 2, the significant reductions of iPTH, FGF-23, tartrate-resistant acid phosphatase 5b, and slightly decreased size of parathyroid gland and stabilized vascular calcification were observed at 24-week follow up and markedly rebounded after discontinuation of cinacalcet. Conclusions: The effectiveness of cinacalcet were still obviously demonstrated even in chronic HD patients with severe SHPT. In addition, the improvements of bone markers and FGF-23, and stabilization of vascular calcification were observed. Therefore, cinacalcet can provide salutary effects on CKD-MBD in severe SHPT and might be an initially effective PTH-lowering therapy prior to surgical parathyroidectomy as well as an alternative treatment in the patients unsuitable for surgery. Clinical trial registration: ClinicalTrials.gov: NCT02056730. Date of registration: February 4, 2014. |
| first_indexed | 2024-12-14T17:15:29Z |
| format | Article |
| id | doaj.art-6d272a2044594e6d9247530dd791bb12 |
| institution | Directory Open Access Journal |
| issn | 0886-022X 1525-6049 |
| language | English |
| last_indexed | 2024-12-14T17:15:29Z |
| publishDate | 2019-01-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Renal Failure |
| spelling | doaj.art-6d272a2044594e6d9247530dd791bb122022-12-21T22:53:26ZengTaylor & Francis GroupRenal Failure0886-022X1525-60492019-01-0141132633310.1080/0886022X.2018.15623561562356The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidismPaweena Susantitaphong0Somratai Vadcharavivad1Teerada Susomboon2Wanchana Singhan3Netsiri Dumrongpisutikul4Ketsuda Jakchairoongruang5Somchai Eiam-Ong6Kearkiat Praditpornsilpa7Chulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityChulalongkorn UniversityBackground: Secondary hyperparathyroidism (SHPT) is associated with high incidences of cardiovascular disease, bone fracture, and mortality. This study was conducted to demonstrate the effectiveness of cinacalcet treatment on chronic kidney disease-mineral bone disorder (CKD-MBD) markers in chronic hemodialysis patients with severe SHPT. Methods: In phase 1, 30 adult HD patients were randomized to cinacalcet or control groups for 12 weeks to explore the achievement of >30% reduction of iPTH. In phase 2, 45 patients were participated to further explore the effect of cinacalcet on CKD-MBD parameters for 24-week follow up and 12 additional weeks after cinacalcet discontinuation. Results: In phase 1, the baseline serum iPTH levels were not different [1374 (955, 1639) pg/mL in the control group vs. 1191 (1005, 1884) pg/mL in the cinacalcet group], the percentage of patients achieving iPTH target were significantly higher in the treatment group [80% vs. 13%, p = .001]. In phase 2, the significant reductions of iPTH, FGF-23, tartrate-resistant acid phosphatase 5b, and slightly decreased size of parathyroid gland and stabilized vascular calcification were observed at 24-week follow up and markedly rebounded after discontinuation of cinacalcet. Conclusions: The effectiveness of cinacalcet were still obviously demonstrated even in chronic HD patients with severe SHPT. In addition, the improvements of bone markers and FGF-23, and stabilization of vascular calcification were observed. Therefore, cinacalcet can provide salutary effects on CKD-MBD in severe SHPT and might be an initially effective PTH-lowering therapy prior to surgical parathyroidectomy as well as an alternative treatment in the patients unsuitable for surgery. Clinical trial registration: ClinicalTrials.gov: NCT02056730. Date of registration: February 4, 2014.http://dx.doi.org/10.1080/0886022X.2018.1562356cinacalcetchronic hemodialysissevere secondary hyperparathyroidism |
| spellingShingle | Paweena Susantitaphong Somratai Vadcharavivad Teerada Susomboon Wanchana Singhan Netsiri Dumrongpisutikul Ketsuda Jakchairoongruang Somchai Eiam-Ong Kearkiat Praditpornsilpa The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism Renal Failure cinacalcet chronic hemodialysis severe secondary hyperparathyroidism |
| title | The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| title_full | The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| title_fullStr | The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| title_full_unstemmed | The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| title_short | The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| title_sort | effectiveness of cinacalcet a randomized open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism |
| topic | cinacalcet chronic hemodialysis severe secondary hyperparathyroidism |
| url | http://dx.doi.org/10.1080/0886022X.2018.1562356 |
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