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 receivedplacebo. 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.
RCT Entities:
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.
Authors: H M Maung; L Elangovan; J M Frazão; J D Bower; B J Kelley; S R Acchiardo; H J Rodriguez; K C Norris; J F Sigala; M Rutkowski; J A Robertson; W G Goodman; B S Levine; R W Chesney; R B Mazess; D M Kyllo; L L Douglass; C W Bishop; J W Coburn Journal: Am J Kidney Dis Date: 2001-03 Impact factor: 8.860
Authors: Santhi K Ganesh; Austin G Stack; Nathan W Levin; Tempie Hulbert-Shearon; Friedrich K Port Journal: J Am Soc Nephrol Date: 2001-10 Impact factor: 10.121
Authors: Geoffrey A Block; Kevin J Martin; Angel L M de Francisco; Stewart A Turner; Morrell M Avram; Michael G Suranyi; Gavril Hercz; John Cunningham; Ali K Abu-Alfa; Piergiorgio Messa; Daniel W Coyne; Francesco Locatelli; Raphael M Cohen; Pieter Evenepoel; Sharon M Moe; Albert Fournier; Johann Braun; Laura C McCary; Valter J Zani; Kurt A Olson; Tilman B Drüeke; William G Goodman Journal: N Engl J Med Date: 2004-04-08 Impact factor: 91.245
Authors: José Portolés; Paula López-Sánchez; María Auxiliadora Bajo; Inés Castellano; Gloria del Peso; José Ramón Rodríguez; Mayte Ribera; Almudena Ortigosa; Rafael Selgas Journal: Perit Dial Int Date: 2012 Mar-Apr Impact factor: 1.756