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Cinacalcet reduces plasma intact parathyroid hormone, serum phosphate and calcium levels in patients with secondary hyperparathyroidism irrespective of its severity

Identifieur interne : 006C61 ( Main/Exploration ); précédent : 006C60; suivant : 006C62

Cinacalcet reduces plasma intact parathyroid hormone, serum phosphate and calcium levels in patients with secondary hyperparathyroidism irrespective of its severity

Auteurs : J. M. Frazao [Portugal] ; P. Messa [Italie] ; G. J. Mellotte [Irlande (pays)] ; H. Geiger [Allemagne] ; E. C. Hagen [Pays-Bas] ; L. D. Quarles [États-Unis] ; P. G. Kerr [Australie] ; A. Banos [Suisse] ; B. Dehmel [Suisse] ; P. Urena [France]

Source :

RBID : Pascal:11-0395718

Descripteurs français

English descriptors

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 × 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 × 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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Le document en format XML

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<name sortKey="Dehmel, B" sort="Dehmel, B" uniqKey="Dehmel B" first="B." last="Dehmel">B. Dehmel</name>
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<country>Allemagne</country>
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<series>
<title level="j" type="main">Clinical nephrology</title>
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<term>Blood plasma</term>
<term>Calcimimetic agent</term>
<term>Calcium phosphate</term>
<term>Chronic kidney disease</term>
<term>Cinacalcet</term>
<term>Human</term>
<term>Hyperparathyroidism</term>
<term>Nephrology</term>
<term>Parathyroid hormone</term>
<term>Recommendation</term>
<term>Secondary</term>
<term>Serum</term>
<term>Urology</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Cinacalcet</term>
<term>Plasma sanguin</term>
<term>Hormone parathyroïde</term>
<term>Néphropathie chronique</term>
<term>Sérum</term>
<term>Phosphate de calcium</term>
<term>Homme</term>
<term>Secondaire</term>
<term>Hyperparathyroïdie</term>
<term>Calcimimétique</term>
<term>Recommandation</term>
<term>Néphrologie</term>
<term>Urologie</term>
</keywords>
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<term>Recommandation</term>
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<front>
<div type="abstract" xml:lang="en">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
<sub>x</sub>
P) was evaluated. Results: Cinacalcet reduced iPTH (47% reduction), P (9%), Ca (7%), and Ca × 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 × 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.</div>
</front>
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<li>Australie</li>
<li>France</li>
<li>Irlande (pays)</li>
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<li>Pays-Bas</li>
<li>Portugal</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region>
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