Department of Internal Medicine & Kidney Research Institute, Hallym University College of Medicine, Anyang, Korea.
Yonsei Med J. 2013 Mar 1;54(2):453-63. doi: 10.3349/ymj.2013.54.2.453.
Cinacalcet is effective for treating refractory secondary hyperparathyroidism (SHPT), but little is known about the response rates and clinical factors influencing the response.
A prospective, single-arm, multi-center study was performed for 24 weeks. Cinacalcet was administered to patients with intact parathyroid hormone (iPTH) level greater than 300 pg/mL. Cinacalcet was started at a dose of 25 mg daily and titrated until 100 mg to achieve a serum iPTH level<300 pg/mL (primary end point). Early response to cinacalcet was defined as a decrease of iPTH more than 50% within one month.
Fifty-seven patients were examined. Based on the magnitude of iPTH decrease, patients were divided into responder (n=47, 82.5%) and non-responder (n=10, 17.5%) groups. Among the responders, 38 achieved the primary end point, whereas 9 patients showed a reduction in serum iPTH of 30% or more, but did not reach the primary end point. Compared to non-responders, responders were significantly older (p=0.026), female (p=0.041), and diabetics (p<0.001). Additionally, early response was observed more frequently in the responders (30/47, 63.8%), of whom the majority (27/30, 90.0%) achieved the primary end point. Multivariate analysis showed that lower baseline iPTH levels [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.93-0.99], the presence of diabetes (OR 46.45, CI 1.92-1125.6) and early response (OR 21.54, CI 2.94-157.7) were significant clinical factors affecting achievement of iPTH target.
Cinacalcet was effective in most hemodialysis patients with refractory SHPT. The presence of an early response was closely associated with the achievement of target levels of iPTH.
西那卡塞治疗难治性继发性甲状旁腺功能亢进（SHPT）有效，但对于其应答率及影响应答的临床因素知之甚少。
进行了一项为期 24 周的前瞻性、单臂、多中心研究。西那卡塞用于甲状旁腺激素（iPTH）水平大于 300pg/ml 的患者。西那卡塞起始剂量为 25mg/天，滴定剂量至 100mg，以达到 iPTH<300pg/ml（主要终点）。西那卡塞早期应答定义为一个月内 iPTH 降低超过 50%。
共检查了 57 例患者。根据 iPTH 降低幅度，患者分为应答者（n=47，82.5%）和无应答者（n=10，17.5%）。在应答者中，38 例达到主要终点，9 例 iPTH 降低 30%或以上，但未达到主要终点。与无应答者相比，应答者年龄较大（p=0.026）、女性（p=0.041）、糖尿病（p<0.001）。此外，应答者中早期应答更为常见（30/47，63.8%），其中大多数（27/30，90.0%）达到了主要终点。多变量分析显示，较低的基线 iPTH 水平[比值比（OR）0.96，95%置信区间（CI）0.93-0.99]、糖尿病存在（OR 46.45，CI 1.92-1125.6）和早期应答（OR 21.54，CI 2.94-157.7）是影响 iPTH 目标达成的显著临床因素。
西那卡塞治疗大多数难治性 SHPT 的血液透析患者有效。早期应答与 iPTH 目标水平的达成密切相关。
