Aims: To evaluate the relationship between the severity of secondary hyperparathyroidism (SHPT) - defined in terms of baseline plasma intact parathyroid hormone (iPTH) level -and the magnitude of response to cinacalcet. Materials and methods: In this post hoc analysis, data were pooled from three randomized, placebo-controlled trials in which dialysis patients with iPTH >= 300 pg/ml were dose-titrated with cinacalcet or placebo in addition to conventional treatment to achieve iPTH <= 250 pg/ml. In 953 patients analyzed (cinacalcet, 545; placebo, 408), baseline iPTH levels were categorized in 100 pg/ml intervals (300 - >= 1,000 pg/ml), and the impact of baseline iPTH on changes in iPTH, phosphate (P), calcium (Ca) and calcium-phosphate product (Ca x P) was evaluated. Results: Cinacalcet reduced iPTH (47% reduction), P (9%), Ca (7%), and Ca x P (15%) across all subgroups. For patients receiving cinacalcet, the mean percentage reduction from baseline in iPTH varied from 35 to 55%, being consistently decreased across the severity subgroups. The mean absolute change in iPTH was more pronounced in patients with higher baseline iPTH levels, particularly in the >= 1,000 pg/ml subgroup vs. the other subgroups. However, as baseline iPTH levels increased, iPTH <= 250 pg/ml was achieved in fewer patients. A trend towards greater absolute change from baseline was observed for P in patients with more severe disease (iPTH >= 800 pg/ml) treated with cinacalcet compared with patients with less severe disease (iPTH 300 - < 800 pg/ml). Conclusions: Cinacalcet lowers plasma iPTH and serum P, Ca and Ca x P levels in dialysis patients with SHPT, regardless of disease severity. Patients with more severe disease experienced greater reductions in PTH and P, but fewer achieved iPTH <= 250 pg/ml by the efficacy assessment phase. Use of cinacalcet when baseline PTH is lower may result in more stable control of SHPT and help to control bone and mineral alterations.
Cinacalcet reduces plasma intact parathyroid hormone,serum phosphate and calcium levels in patients with secondary hyperparathyroidismirrespective of its severity / J. Frazão, P. Messa, G. Mellotte, H. Geiger, E. Hagen, L. Quarles, P. Kerr, A. Baños, B. Dehmel, P. Urena. - In: CLINICAL NEPHROLOGY. - ISSN 0301-0430. - 76:3(2011), pp. 233-243.
Cinacalcet reduces plasma intact parathyroid hormone,serum phosphate and calcium levels in patients with secondary hyperparathyroidismirrespective of its severity
P. Messa;
2011
Abstract
Aims: To evaluate the relationship between the severity of secondary hyperparathyroidism (SHPT) - defined in terms of baseline plasma intact parathyroid hormone (iPTH) level -and the magnitude of response to cinacalcet. Materials and methods: In this post hoc analysis, data were pooled from three randomized, placebo-controlled trials in which dialysis patients with iPTH >= 300 pg/ml were dose-titrated with cinacalcet or placebo in addition to conventional treatment to achieve iPTH <= 250 pg/ml. In 953 patients analyzed (cinacalcet, 545; placebo, 408), baseline iPTH levels were categorized in 100 pg/ml intervals (300 - >= 1,000 pg/ml), and the impact of baseline iPTH on changes in iPTH, phosphate (P), calcium (Ca) and calcium-phosphate product (Ca x P) was evaluated. Results: Cinacalcet reduced iPTH (47% reduction), P (9%), Ca (7%), and Ca x P (15%) across all subgroups. For patients receiving cinacalcet, the mean percentage reduction from baseline in iPTH varied from 35 to 55%, being consistently decreased across the severity subgroups. The mean absolute change in iPTH was more pronounced in patients with higher baseline iPTH levels, particularly in the >= 1,000 pg/ml subgroup vs. the other subgroups. However, as baseline iPTH levels increased, iPTH <= 250 pg/ml was achieved in fewer patients. A trend towards greater absolute change from baseline was observed for P in patients with more severe disease (iPTH >= 800 pg/ml) treated with cinacalcet compared with patients with less severe disease (iPTH 300 - < 800 pg/ml). Conclusions: Cinacalcet lowers plasma iPTH and serum P, Ca and Ca x P levels in dialysis patients with SHPT, regardless of disease severity. Patients with more severe disease experienced greater reductions in PTH and P, but fewer achieved iPTH <= 250 pg/ml by the efficacy assessment phase. Use of cinacalcet when baseline PTH is lower may result in more stable control of SHPT and help to control bone and mineral alterations.
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