title: Safety and efficiency of treatment with cinacalcet of haemodialysed patients with chronic kidney disease and secondary hyperparathyroidism.
abstract: BACKGROUND
  Secondary hyperparathyroidism (sHPT) is a common disorder in haemodialysed patients with chronic kidney disease (CKD). Cinacalcet increases the sensitivity of calcium receptor to the serum calcium, thus reducing serum parathormone (PTH) concentration. The aim of this study was to assess the safety and efficacy of six-month treatment with cinacalcet in haemodialysed CKD patients with sHPT in upper Silesia.
  
  
  METHODS
  71 haemodialysed CKD patients with sHPT (PTH 〉 300 pg/mL) were enrolled in this study. The target was to decrease PTH concentration below 300 pg/mL. PTH (ECL; Roche, Mannheim, Germany), calcium and phosphate concentration was assessed before the first dose of cinacalcet and then after three and six months of treatment, before haemodialysis session. The results are shown as means and 95% confidence index.
  
  
  RESULTS
  58 patients completed the study. There was a significant decrease in serum PTH concentration from 1,138 pg/mL (931-1,345 pg/mL) to 772 pg/mL (551-992 pg/mL) after three months of treatment (p 〈 0.0001) and to 635 pg/mL (430-839 pg/mL; p 〈 0.0001) after six months. The target PTH concentration was reached in 25% of the patients after three months and in 45% after six months of treatment. Cinacalcet was ineffective in decreasing serum PTH in 16 (28%) patients. There were no significant differences in serum calcium and phosphate concentration during the observation period.
  
  
  CONCLUSIONS
  1. Cinacalcet decreases serum PTH concentration in most haemodialysed CKD patients with sHPT. 2. In 28% of patients, resistance to treatment with cinacalcet was observed. 3. Cinacalcet treatment was well tolerated and caused only a few side effects.
authors.affiliation: Department of Nephrology, Endocrinology and Metabolic Diseases, Medical University of Silesia, Katowice, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Kuczera
authors.forename: Marcin
authors.initials: M
authors.lastname: Adamczak
authors.forename: Andrzej
authors.initials: A
authors.lastname: Więcek
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000009:adverse effects / Q000627:therapeutic use*; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000097:blood; D016032:Randomized Controlled Trials as Topic; D006435:Renal Dialysis / Q000379:methods; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000628:therapy*; D016896:Treatment Outcome
chemical_list: D009281:Naphthalenes; D010281:Parathyroid Hormone; D010710:Phosphates; D002118:Calcium; D000069449:Cinacalcet