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Cinacalcet Hydrochloride Therapy for Secondary Hyperparathyroidism in Hemodialysis Patients
Abstract: This study compared the efficacy of a cinacalcetbased regimen with unrestricted conventional therapy(vitamin D and phosphate binders) for achieving Kidney Disease Outcome Quality Initiative (K/DOQI) targets for dialysis patients. In this multicenter, prospective study,
hemodialysis patients with poorly controlled secondary hyperparathyroidism (SHPT) were randomized to receive a cinacalcet-based regimen (n = 55) or a conventional therapy (n = 27). Doses of cinacalcet, vitamin D sterols, and phosphate binders were adjusted during a 12-week dosetitration
phase to achieve intact parathyroid hormone (iPTH) levels 31.8 pmol/L. The primary end point was the percentage of patients with values in this range during a 24-week efficacy-assessment phase. The clinical response to 36-week cinacalcet treatment was evaluated. A dual energy X-ray absorptiometry was performed before and after 36 weeks of cinacalcet therapy. Fifty-eight percent of the cinacalcet group reached the primary end point, as compared with 19% of the conventional therapy group (P = 0.001). A higher percentage of patients receiving the cinacalcet-based regimen versus conventional therapy achieved the targets for calcium, phosphorus and Ca ¥ P. Achievement of targets was greatest in patients with less
severe disease (intact PTH range, 31.8 to 53 pmol/L). Cinacalcet therapy increased proximal femur bone mineral density (BMD), but did not affect the lumbar spine. Itching intensity decreased significantly. Cinacalcet based treatment facilitates achievement of the K/DOQI targets for iPTH and bone mineral metabolism compared with conventional therapy in hemodialysis patients. Suppressionof iPTH with cinacalcet reverses bone loss in the proximal femur. Cinacalcet alleviated itching.
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