使用盐酸西那卡塞实现NKF-K/DOQI骨代谢及疾病治疗目标。

Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl.

作者信息

Moe Sharon M, Chertow Glenn M, Coburn Jack W, Quarles L Darryl, Goodman William G, Block Geoffrey A, Drüeke Tilman B, Cunningham John, Sherrard Donald J, McCary Laura C, Olson Kurt A, Turner Stewart A, Martin Kevin J

机构信息

Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.

出版信息

Kidney Int. 2005 Feb;67(2):760-71. doi: 10.1111/j.1523-1755.2005.67139.x.

DOI:10.1111/j.1523-1755.2005.67139.x

PMID:15673327

Abstract

BACKGROUND

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (NKF-K/DOQItrade mark) has established guidelines for treatment of secondary hyperparathyroidism (HPT). The ability of cinacalcet HCl (Sensipartrade mark) treatment to improve achievement of target levels of parathyroid hormone (PTH), calcium, phosphorus, and calcium-phosphorus product (Ca x P) was investigated in subjects on dialysis with secondary HPT.

METHODS

Data were combined from three placebo-controlled, double-blind, 26-week studies with similar design that randomized 1136 subjects on dialysis to receive traditional therapy plus cinacalcet or placebo. Oral cinacalcet was titrated from 30 to 180 mg/day. Achievement of K/DOQI goals was determined for each treatment group overall and for subgroups defined by baseline intact PTH (iPTH) and Ca x P levels.

RESULTS

Cinacalcet-treated subjects were more likely to achieve a mean iPTH </=300 pg/mL (31.8 pmol/L) than were control subjects on traditional therapy (56% vs. 10%, P < 0.001). Cinacalcet-treated subjects were more likely to achieve concentrations of serum calcium within 8.4 to 9.5 mg/dL (2.10-2.37 mmol/L) and serum phosphorus within 3.5 to 5.5 mg/dL (1.13-1.78 mmol/L) than were control subjects (49% vs. 24% and 46% vs. 33%, P < 0.001 for each). Cinacalcet also improved achievement of Ca x P < 55 mg(2)/dL(2) (4.44 mmol(2)/L(2)) and concurrent achievement of Ca x P < 55 mg(2)/dL(2) (4.44 mmol(2)/L(2)) and iPTH </=300 pg/mL (31.8 pmol/L) (65% vs. 36% and 41% vs. 6%, P < 0.001 for each).

CONCLUSION

In subjects on dialysis with secondary HPT, cinacalcet facilitates achievement of the K/DOQI-recommended targets for PTH, calcium, phosphorus, and Ca x P.

摘要

背景

美国国家肾脏基金会的肾脏病预后质量倡议（NKF-K/DOQI商标）制定了继发性甲状旁腺功能亢进（HPT）的治疗指南。在接受透析的继发性HPT患者中，研究了盐酸西那卡塞（Sensipar商标）治疗对提高甲状旁腺激素（PTH）、钙、磷和钙磷乘积（Ca×P）目标水平达成情况的影响。

方法

合并三项设计相似的安慰剂对照、双盲、26周研究的数据，这些研究将1136例接受透析的患者随机分组，分别接受传统治疗加西那卡塞或安慰剂。口服西那卡塞的剂量从30毫克/天滴定至180毫克/天。确定每个治疗组总体以及根据基线完整PTH（iPTH）和Ca×P水平定义的亚组的K/DOQI目标达成情况。

结果

与接受传统治疗的对照组相比，接受西那卡塞治疗的患者更有可能使平均iPTH≤300 pg/mL（31.8 pmol/L）（56%对10%，P<0.001）。与对照组相比，接受西那卡塞治疗的患者更有可能使血清钙浓度维持在8.4至9.5 mg/dL（2.10 - 2.37 mmol/L），血清磷浓度维持在3.5至5.5 mg/dL（1.13 - 1.78 mmol/L）（分别为49%对24%和46%对33%，每项P<0.001）。西那卡塞还改善了Ca×P<55 mg²/dL²（4.44 mmol²/L²）的达成情况以及Ca×P<55 mg²/dL²（4.44 mmol²/L²）和iPTH≤300 pg/mL（31.8 pmol/L）同时达标的情况（分别为65%对36%和41%对6%，每项P<0.001）。