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Title: Simultaneous control of PTH and CaxP Is sustained over three years of treatment with cinacalcet HCl
Authors: Sprague, Stuart M ×
Evenepoel, Pieter
Curzi, Mario P
González, Maria Teresa
Husserl, Fred E
Kopyt, Nelson
Sterling, Lulu Ren
Mix, Chris
Wong, Gordon #
Issue Date: Sep-2009
Publisher: American Society of Nephrology
Series Title: Clinical Journal of the American Society of Nephrology vol:4 issue:9 pages:1465-76
Abstract: BACKGROUND & OBJECTIVES: Chronic kidney disease (CKD) is commonly complicated by secondary hyperparathyroidism (SHPT), leading to increased risk of morbidity and mortality. SHPT is a progressive disease often requiring long-term therapy to control parathyroid hormone (PTH) and mineral imbalances. Vitamin D sterols and phosphate binders, used as traditional therapies to lower PTH and phosphorus, may provide inadequate long-term control for many dialysis patients. Cinacalcet, by simultaneously lowering PTH, calcium, phosphorus, and calcium-phosphorus levels, may maintain PTH and mineral balance in these individuals. However, as with traditional therapies, long-term data are limited. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENT: Dialysis subjects from at least one of five lead-in studies (double-blind placebo-controlled, including one extension trial) completing up to 52 wk of either cinacalcet or placebo were eligible for this open-label extension study, including an 8-wk dose titration (initiated at 30 mg/d), followed by 24-wk maintenance and up to 132 wk of follow-up. Final efficacy analysis was at week 180. RESULTS: Three hundred thirty-four of 589 enrolled subjects received cinacalcet from the beginning of the lead-in study. Weekly median PTH values were < or =300 pg/ml (weeks 16 through 180) and median CaxP values were < or =55 mg(2)/dl(2) (weeks 4 through 180). Similar results were exhibited in the 255 subjects who initially received placebo. Among the patients exposed to cinacalcet from the beginning of the lead-in study, 3% of subjects exhibited treatment-related serious adverse events. CONCLUSIONS: Cinacalcet effectively maintained PTH, Ca and P reductions in dialysis subjects for up to 180 wk.
ISSN: 1555-9041
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Nephrology
× corresponding author
# (joint) last author

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