Impact of cinacalcet hydrochloride on the achievement of the Japanese Society for Dialysis Therapy (JSDT) guideline targets: a post-hoc analysis of the KRN1493 study.

The Japanese Society for Dialysis Therapy (JSDT) released the Guidelines for the Management of Secondary Hyperparathyroidism in Chronic Dialysis Patients (JSDT guidelines), which set target ranges for calcium (8.4-10.0 mg/dL), phosphorus (3.5-6.0 mg/dL) and intact parathyroid hormone (PTH) (60-180 pg/mL); however, achieving the guideline targets is difficult and challenging. In this post-hoc analysis, we evaluate the impact of cinacalcet on the achievement of the JSDT targets. After a treatment period of 14 weeks, 26% of the cinacalcet group achieved intact PTH levels within the target ranges (P < 0.001, compared with the control group). A significantly greater proportion achieved the targets for calcium and phosphorus, as compared with control patients (65% vs. 45%, P = 0.015; 68% vs. 47%, P = 0.009, respectively). The proportion of patients in whom serum calcium and phosphorus were controlled to within the target ranges increased from 21% at baseline to 44% (P < 0.001). The combined targets of three parameters were achieved by 17% of cinacalcet-treated patients, while none of the control patients achieved these parameters simultaneously (P < 0.001). Cinacalcet treatment also efficaciously reduced elevated serum calcium and phosphorus levels. Even in patients with baseline intact PTH levels >500 pg/mL, where parathyroidectomy has been recommended in the JSDT guidelines, 20% of the cinacalcet group achieved the target intact PTH levels. Longer-term cinacalcet treatment aimed at the JSDT targets may lead to further reductions in PTH secretion. Further studies are required to examine the potential benefit of cinacalcet and to revise the current guidelines relating to adequate use of cinacalcet.