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Simultaneous Control of PTH and CaxP Is Sustained over Three Years of Treatment with Cinacalcet HCl

Stuart M. Sprague^*, Pieter Evenepoel, Mario P. Curzi, Maria Teresa González, Fred E. Husserl^||, Nelson Kopyt^¶, Lulu Ren Sterling^**, Chris Mix, and Gordon Wong

^* Evanston Northwestern Healthcare and Northwestern University Feinberg School of Medicine, Evanston, Ilinois; Department of Nephrology, University Hospital Gasthuisberg, KU Leuven, Belgium; Diablo Nephrology Medical Group, Inc., Walnut Creek, California; Department of Nephrology, Hospital Universitario de Bellvitge, Barcelona, Spain; ^|| Ochsner Health System, New Orleans, Louisiana; ^¶ Nephrology–Hypertension Associates of Lehigh Valley, Allentown, Pennsylvania; ^** Department of Biostatistics, Amgen, Inc., South San Francisco, California; Department of General Medicine, Amgen, Inc., Thousand Oaks, California; and Credit Valley Hospital, Mississauga, Ontario, Canada

Correspondence: Dr. Stuart M. Sprague, Evanston Northwestern Healthcare, 2650 Ridge Avenue, Evanston, IL 60201. Phone: 847-570-2512; Fax: 847-570-1696; E-mail: ssprague{at}northwestern.edu

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 300 pg/ml (weeks 16 through 180) and median CaxP values were 55 mg²/dl² (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.

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Keitaro Yokoyama
Clin. J. Am. Soc. Nephrol. 2009 4: 1405-1408. [Full Text] [PDF]

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