title: Cinacalcet hydrochloride therapy for secondary hyperparathyroidism in hemodialysis patients.
abstract: This study compared the efficacy of a cinacalcet-based 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 dose-titration 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. Suppression of iPTH with cinacalcet reverses bone loss in the proximal femur. Cinacalcet alleviated itching.
authors: Nephrology Division, Internal Medicine Department Clinical Pathology Department, Faculty of Medicine, Tanta University, Tanta, Egypt. shafey70@yahoo.com
authors: Eid M
authors: EM
authors: El-Shafey
authors: Ali E
authors: AE
authors: Alsahow
authors: Khalid
authors: K
authors: Alsaran
authors: Alaa A
authors: AA
authors: Sabry
authors: Mohamed
authors: M
authors: Atia
mesh_terms: D015502:Absorptiometry, Photon; D000328:Adult; D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D002614:Chelating Agents / Q000627:therapeutic use; D000069449:Cinacalcet; D005260:Female; D005269:Femur; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000627:therapeutic use*; D010758:Phosphorus / Q000097:blood; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy / Q000209:etiology; D006435:Renal Dialysis; D016896:Treatment Outcome; D014807:Vitamin D / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D002614:Chelating Agents; D009281:Naphthalenes; D014807:Vitamin D; D010758:Phosphorus; D000069449:Cinacalcet