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Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism.
Clin Exp Nephrol. 2018 Apr; 22(2):426-436.CE

Abstract

BACKGROUND

Secondary hyperparathyroidism (SHPT) is a serious major complication in hemodialysis patients with chronic kidney disease. Long-term maintenance of serum phosphate, calcium, and parathyroid hormone (PTH) levels in appropriate ranges in these patients is a major challenge. We investigated the efficacy and safety of long-term treatment with etelcalcetide, a novel intravenous calcimimetic, in Japanese SHPT patients on long-term hemodialysis.

METHODS

This study was a multicenter open-label study. A total of 191 hemodialysis patients with serum intact PTH (iPTH) > 240 pg/mL were enrolled. Etelcalcetide was administered thrice weekly for 52 weeks, with an initial dose of 5 mg and flexibility to adjust the dose between 2.5 and 15 mg and to adjust the dosing of concomitant medications for SHPT. The efficacy endpoint was the proportion of patients with serum iPTH decreased to the target range (60-240 pg/mL).

RESULTS

Serum iPTH levels decreased immediately after etelcalcetide was started. At the end of the study, 87.5% (95% confidence interval 81.4-92.2; 140/160 patients) of patients achieved target serum iPTH levels, with control of serum calcium and phosphate levels. Adverse events, mostly mild to moderate, were reported by 96.8% of patients and led to study discontinuation in 7.4% of patients. Nausea, vomiting, and symptomatic hypocalcemia were found in 4.7, 9.5, and 1.1%, with 0.5, 1.1, and 1.1% considered treatment-related.

CONCLUSIONS

Etelcalcetide effectively maintained serum iPTH, calcium, and phosphate levels in appropriate ranges with concomitant medications for SHPT for 52 weeks in Japanese hemodialysis patients, and was safe and well tolerated.

REGISTRATION NUMBER

JapicCTI-142665.

Authors+Show Affiliations

Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama, 641-8509, Japan. taki@wakayama-med.ac.jp.Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Japan.Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.Sekikawa Hospital, Tokyo, Japan.Clinical Development Planning, Ono Pharmaceutical Co. Ltd, Osaka, Japan.Data Science, Ono Pharmaceutical Co. Ltd, Osaka, Japan.Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.No affiliation info available

Pub Type(s)

Journal Article
Multicenter Study

Language

eng

PubMed ID

28836058

Citation

Shigematsu, Takashi, et al. "Long-term Effects of Etelcalcetide as Intravenous Calcimimetic Therapy in Hemodialysis Patients With Secondary Hyperparathyroidism." Clinical and Experimental Nephrology, vol. 22, no. 2, 2018, pp. 426-436.
Shigematsu T, Fukagawa M, Yokoyama K, et al. Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. Clin Exp Nephrol. 2018;22(2):426-436.
Shigematsu, T., Fukagawa, M., Yokoyama, K., Akiba, T., Fujii, A., Odani, M., & Akizawa, T. (2018). Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. Clinical and Experimental Nephrology, 22(2), 426-436. https://doi.org/10.1007/s10157-017-1442-5
Shigematsu T, et al. Long-term Effects of Etelcalcetide as Intravenous Calcimimetic Therapy in Hemodialysis Patients With Secondary Hyperparathyroidism. Clin Exp Nephrol. 2018;22(2):426-436. PubMed PMID: 28836058.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term effects of etelcalcetide as intravenous calcimimetic therapy in hemodialysis patients with secondary hyperparathyroidism. AU - Shigematsu,Takashi, AU - Fukagawa,Masafumi, AU - Yokoyama,Keitaro, AU - Akiba,Takashi, AU - Fujii,Akifumi, AU - Odani,Motoi, AU - Akizawa,Tadao, AU - ,, Y1 - 2017/08/23/ PY - 2017/02/22/received PY - 2017/07/03/accepted PY - 2017/8/25/pubmed PY - 2018/9/5/medline PY - 2017/8/25/entrez KW - Calcimimetics KW - Etelcalcetide KW - Fibroblast growth factor 23 KW - Hemodialysis KW - Long-term therapy KW - Secondary hyperparathyroidism SP - 426 EP - 436 JF - Clinical and experimental nephrology JO - Clin Exp Nephrol VL - 22 IS - 2 N2 - BACKGROUND: Secondary hyperparathyroidism (SHPT) is a serious major complication in hemodialysis patients with chronic kidney disease. Long-term maintenance of serum phosphate, calcium, and parathyroid hormone (PTH) levels in appropriate ranges in these patients is a major challenge. We investigated the efficacy and safety of long-term treatment with etelcalcetide, a novel intravenous calcimimetic, in Japanese SHPT patients on long-term hemodialysis. METHODS: This study was a multicenter open-label study. A total of 191 hemodialysis patients with serum intact PTH (iPTH) > 240 pg/mL were enrolled. Etelcalcetide was administered thrice weekly for 52 weeks, with an initial dose of 5 mg and flexibility to adjust the dose between 2.5 and 15 mg and to adjust the dosing of concomitant medications for SHPT. The efficacy endpoint was the proportion of patients with serum iPTH decreased to the target range (60-240 pg/mL). RESULTS: Serum iPTH levels decreased immediately after etelcalcetide was started. At the end of the study, 87.5% (95% confidence interval 81.4-92.2; 140/160 patients) of patients achieved target serum iPTH levels, with control of serum calcium and phosphate levels. Adverse events, mostly mild to moderate, were reported by 96.8% of patients and led to study discontinuation in 7.4% of patients. Nausea, vomiting, and symptomatic hypocalcemia were found in 4.7, 9.5, and 1.1%, with 0.5, 1.1, and 1.1% considered treatment-related. CONCLUSIONS: Etelcalcetide effectively maintained serum iPTH, calcium, and phosphate levels in appropriate ranges with concomitant medications for SHPT for 52 weeks in Japanese hemodialysis patients, and was safe and well tolerated. REGISTRATION NUMBER: JapicCTI-142665. SN - 1437-7799 UR - https://wwww.unboundmedicine.com/medline/citation/28836058/Long_term_effects_of_etelcalcetide_as_intravenous_calcimimetic_therapy_in_hemodialysis_patients_with_secondary_hyperparathyroidism_ L2 - https://dx.doi.org/10.1007/s10157-017-1442-5 DB - PRIME DP - Unbound Medicine ER -