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The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism.
Ren Fail. 2019 Nov; 41(1):326-333.RF

Abstract

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.

Authors+Show Affiliations

a Division of Nephrology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital , Chulalongkorn University , Bangkok , Thailand.b Department of Pharmacy Practice , Chulalongkorn University , Bangkok , Thailand.b Department of Pharmacy Practice , Chulalongkorn University , Bangkok , Thailand.b Department of Pharmacy Practice , Chulalongkorn University , Bangkok , Thailand.c Department of Radiology, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand.c Department of Radiology, Faculty of Medicine , Chulalongkorn University , Bangkok , Thailand.a Division of Nephrology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital , Chulalongkorn University , Bangkok , Thailand.a Division of Nephrology, Department of Medicine, Faculty of Medicine, King Chulalongkorn Memorial Hospital , Chulalongkorn University , Bangkok , Thailand.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31014177

Citation

Susantitaphong, Paweena, et al. "The Effectiveness of Cinacalcet: a Randomized, Open Label Study in Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism." Renal Failure, vol. 41, no. 1, 2019, pp. 326-333.
Susantitaphong P, Vadcharavivad S, Susomboon T, et al. The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism. Ren Fail. 2019;41(1):326-333.
Susantitaphong, P., Vadcharavivad, S., Susomboon, T., Singhan, W., Dumrongpisutikul, N., Jakchairoongruang, K., Eiam-Ong, S., & Praditpornsilpa, K. (2019). The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism. Renal Failure, 41(1), 326-333. https://doi.org/10.1080/0886022X.2018.1562356
Susantitaphong P, et al. The Effectiveness of Cinacalcet: a Randomized, Open Label Study in Chronic Hemodialysis Patients With Severe Secondary Hyperparathyroidism. Ren Fail. 2019;41(1):326-333. PubMed PMID: 31014177.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effectiveness of cinacalcet: a randomized, open label study in chronic hemodialysis patients with severe secondary hyperparathyroidism. AU - Susantitaphong,Paweena, AU - Vadcharavivad,Somratai, AU - Susomboon,Teerada, AU - Singhan,Wanchana, AU - Dumrongpisutikul,Netsiri, AU - Jakchairoongruang,Ketsuda, AU - Eiam-Ong,Somchai, AU - Praditpornsilpa,Kearkiat, PY - 2019/4/25/entrez PY - 2019/4/25/pubmed PY - 2019/6/7/medline KW - Cinacalcet KW - chronic hemodialysis KW - severe secondary hyperparathyroidism SP - 326 EP - 333 JF - Renal failure JO - Ren Fail VL - 41 IS - 1 N2 - 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. SN - 1525-6049 UR - https://wwww.unboundmedicine.com/medline/citation/31014177/The_effectiveness_of_cinacalcet:_a_randomized_open_label_study_in_chronic_hemodialysis_patients_with_severe_secondary_hyperparathyroidism_ DB - PRIME DP - Unbound Medicine ER -