Cinacalcet Treatment of Primary Hyperparathyroidism: Biochemical and Bone Densitometric Outcomes in a Five-Year Study
Cinacalcet Treatment of Primary Hyperparathyroidism: Biochemical and Bone Densitometric Outcomes in a Five-Year Study
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DOI：
10.1210/jc.2009-1472
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发表时间：
2009-12-01
影响因子：
5.8
通讯作者：
Shoback, Dolores
中科院分区：
文献类型：
--
作者：
Peacock, Munro;Bolognese, Michael A.;Shoback, Dolores
内容：原发性甲状旁腺功能亢进症（PHPT）的特征是血清钙水平长期升高，PTH水平正常或升高。目的：我们的目的是评估西那卡塞在PHPT患者中的长期耐受性、安全性和有效性。设计和设置：在美国的14个研究中心进行了一项为期4.5年的开放标签扩展研究。患者或其他参与者：45名PHPT受试者来自一项为期1年的双盲、安慰剂对照试验，他们继续参与本研究。母研究结束后，所有受试者均接受西那卡塞30 mg每日两次治疗，如果血清钙水平为10.3 mg/dl或更高，则在12周滴定期间增加至50 mg每日两次，然后维持西那卡塞长达4.5年。主要结果测量：评估包括血清钙、PTH、磷酸盐和碱性磷酸酶以及区域骨矿物质密度（aBMD）。生命体征，安全化学和血液学，和不良事件进行了监测through.Results：与基线相比，西那卡塞治疗改善PHPT的生化指标，包括降低血清钙和甲状旁腺激素，增加血清磷酸盐，碱性磷酸酶略有增加。未观察到脊柱、髋关节或腕关节aBMD的z评分变化，年度百分比变化与未经治疗的绝经后妇女或PHPT患者的报告一致。安全生化保持正常，不良事件（最常见的关节痛，肌痛，腹泻，呼吸道感染，恶心）是轻度至中度severity.Conclusions：治疗PHPT患者西那卡塞长达5.5年维持normocalemia，降低血浆PTH，增加血清磷酸盐和碱性磷酸酶，对aBMD没有显着影响，耐受性良好。（临床内分泌代谢杂志94：4860-4867，2009）
Context: Primary hyperparathyroidism (PHPT) is characterized by chronically elevated serum calcium and inappropriately normal or increased PTH.Objective: Our objective was to evaluate long-term tolerability, safety, and efficacy of cinacalcet in PHPT patients.Design and Setting: A 4.5-yr open-label extension study was conducted at 14 study centers in the United States.Patients or Other Participants: Forty-five subjects with PHPT from a double-blind, placebo-controlled, 1-yr trial were continued into this study.Interventions: After the parent study, all subjects were treated with 30 mg cinacalcet twice daily, increasing to 50 mg twice daily during the 12-wk titration if serum calcium levels were 10.3 mg/dl or higher and then maintained on cinacalcet for up to 4.5 yr.Main Outcome Measures: Assessments included serum calcium, PTH, phosphate and alkaline phosphatase, and areal bone mineral density (aBMD). Vital signs, safety chemistries and hematology, and adverse events were monitored throughout.Results: Compared with baseline, cinacalcet treatment improved biochemical measures of PHPT including reducing serum calcium and PTH and increasing serum phosphate with slight increases in alkaline phosphatase. No changes in z-scores of aBMD at spine, hip, or wrist were seen with annual percent changes, consistent with reports for untreated postmenopausal women or PHPT patients. Safety biochemistries remained normal, and adverse events (most commonly arthralgia, myalgia, diarrhea, respiratory infection, and nausea) were mild to moderate in severity.Conclusions: Treatment of PHPT patients with cinacalcet for up to 5.5 yr maintained normocalcemia, reduced plasma PTH, increased serum phosphate and alkaline phosphatase with no significant effects on aBMD, and was well tolerated. (J Clin Endocrinol Metab 94: 4860-4867, 2009)