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Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis.
Hemodial Int. 2016 10; 20(4):589-600.HI

Abstract

Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels.

Authors+Show Affiliations

Shanghai Changzheng Hospital, Shanghai, China.Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. chen-nan@medmail.com.cn.Zhongshan Hospital Fudan University, Shanghai, China.The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.Sichuan Provincial People's Hospital, Chengdu, China.Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.Peking University People's Hospital, Beijing, China.Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.Peking Union Medical College Hospital, Beijing, China.Nanfang Hospital, Guangzhou, China.Peking University First Hospital, Beijing, China.The Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.Kyowa Hakko Kirin China Pharmaceutical Co., Ltd, China.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26940692

Citation

Mei, Changlin, et al. "Efficacy and Safety of Cinacalcet On Secondary Hyperparathyroidism in Chinese Chronic Kidney Disease Patients Receiving Hemodialysis." Hemodialysis International. International Symposium On Home Hemodialysis, vol. 20, no. 4, 2016, pp. 589-600.
Mei C, Chen N, Ding X, et al. Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis. Hemodial Int. 2016;20(4):589-600.
Mei, C., Chen, N., Ding, X., Yu, X., Wang, L., Qian, J., Wang, M., Jiang, G., Li, X., Hou, F., Zuo, L., Wang, N., & Liu, H. (2016). Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis. Hemodialysis International. International Symposium On Home Hemodialysis, 20(4), 589-600. https://doi.org/10.1111/hdi.12410
Mei C, et al. Efficacy and Safety of Cinacalcet On Secondary Hyperparathyroidism in Chinese Chronic Kidney Disease Patients Receiving Hemodialysis. Hemodial Int. 2016;20(4):589-600. PubMed PMID: 26940692.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis. AU - Mei,Changlin, AU - Chen,Nan, AU - Ding,Xiaoqiang, AU - Yu,Xueqing, AU - Wang,Li, AU - Qian,Jiaqi, AU - Wang,Mei, AU - Jiang,Gengru, AU - Li,Xuemei, AU - Hou,Fanfan, AU - Zuo,Li, AU - Wang,Niansong, AU - Liu,Hong, Y1 - 2016/03/04/ PY - 2016/3/5/pubmed PY - 2017/7/25/medline PY - 2016/3/5/entrez KW - Calcium KW - Cinacalcet KW - phosphorus KW - secondary hyperparathyroidism KW - serum intact parathyroid hormone SP - 589 EP - 600 JF - Hemodialysis international. International Symposium on Home Hemodialysis JO - Hemodial Int VL - 20 IS - 4 N2 - Introduction Secondary hyperparathyroidism (SHPT) develops in patients with chronic renal failure. Cinacalcet hydrochloride has been used successfully in U.S., Europe, and Japan in the treatment of SHPT, while maintaining serum levels of calcium and phosphorus. The efficacy and safety profile of Cinacalcet treatment vs. conventional treatments has been of great interest in clinical practice. In this recent phase III study conducted in China, efficacy and safety of a calcimimetic agent, Cinacalcet (Kyowa Hakko Kirin Co., Ltd.), were assessed for SHPT treatment in stable chronic renal disease patients on hemodialysis. Methods In this double-blind, multicenter, placebo-controlled, randomized phase III study, 238 subjects were enrolled in 12 centers and randomly divided into a Cinacalcet group and a placebo group. The percentage of patients achieving a serum parathyroid hormone (PTH) level ≤250 pg/mL was the primary efficacy end point. Serum calcium and phosphorus levels were measured. Adverse events and serious adverse events were recorded, and causal analysis performed. Findings In primary analysis, 25.4% of the Cinacalcet group and 3.5% of the placebo group achieved the primary end point (PTH ≤250 pg/mL). Calcium and phosphorus levels and calcium-phosphorus product were lower in the Cinacalcet group compared with the placebo group. Eleven serious adverse events were reported and considered to be not related to study drugs. Mild to moderate hypocalcemia and reduced calcium levels were reported and considered to be Cinacalcet related. Discussion This phase III study demonstrated that Cinacalcet is effective and well tolerated in treating SHPT in Chinese chronic kidney disease patients on hemodialysis, and in a patient population with much higher baseline PTH levels. SN - 1542-4758 UR - https://wwww.unboundmedicine.com/medline/citation/26940692/Efficacy_and_safety_of_Cinacalcet_on_secondary_hyperparathyroidism_in_Chinese_chronic_kidney_disease_patients_receiving_hemodialysis_ DB - PRIME DP - Unbound Medicine ER -