title: Efficacy and safety of Cinacalcet on secondary hyperparathyroidism in Chinese chronic kidney disease patients receiving hemodialysis.
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.affiliation: Shanghai Changzheng Hospital, Shanghai, China.
authors.forename: Changlin
authors.initials: C
authors.lastname: Mei
authors.affiliation: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. chen-nan@medmail.com.cn.
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
authors.affiliation: Zhongshan Hospital Fudan University, Shanghai, China.
authors.forename: Xiaoqiang
authors.initials: X
authors.lastname: Ding
authors.affiliation: The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
authors.forename: Xueqing
authors.initials: X
authors.lastname: Yu
authors.affiliation: Sichuan Provincial People's Hospital, Chengdu, China.
authors.forename: Li
authors.initials: L
authors.lastname: Wang
authors.affiliation: Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Jiaqi
authors.initials: J
authors.lastname: Qian
authors.affiliation: Peking University People's Hospital, Beijing, China.
authors.forename: Mei
authors.initials: M
authors.lastname: Wang
authors.affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Gengru
authors.initials: G
authors.lastname: Jiang
authors.affiliation: Peking Union Medical College Hospital, Beijing, China.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Li
authors.affiliation: Nanfang Hospital, Guangzhou, China.
authors.forename: Fanfan
authors.initials: F
authors.lastname: Hou
authors.affiliation: Peking University First Hospital, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Zuo
authors.affiliation: The Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors.forename: Niansong
authors.initials: N
authors.lastname: Wang
authors.affiliation: Kyowa Hakko Kirin China Pharmaceutical Co., Ltd, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Liu
mesh_terms: D044466:Asian People; D057966:Calcimimetic Agents / Q000627:therapeutic use*; D002681:China; D000069449:Cinacalcet / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000473:pathology; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects*
chemical_list: D057966:Calcimimetic Agents; D000069449:Cinacalcet
keywords: Calcium; Cinacalcet; phosphorus; secondary hyperparathyroidism; serum intact parathyroid hormone