title: Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis.
abstract: BACKGROUND
  Secondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT).
  
  
  METHODS
  A retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment.
  
  
  RESULTS
  A total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7-83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%).
  
  
  CONCLUSIONS
  Cinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders.
authors: Department of Pharmacy, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
authors: Ariadna
authors: http://orcid.org/0000-0002-2983-5496
authors: A
authors: Pérez-Ricart
authors: Department of Nephrology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
authors: Maria
authors: M
authors: Galicia-Basart
authors: Department of Pharmacy, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
authors: Maria
authors: M
authors: Alcalde-Rodrigo
authors: Department of Nephrology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
authors: Alfons
authors: A
authors: Segarra-Medrano
authors: Pharmacy Faculty, Universitat de Barcelona, Barcelona, Spain.
authors: Josep-Maria
authors: JM
authors: Suñé-Negre
authors: Department of Pharmacy, Hospital Universitari Vall d'Hebron, Barcelona, Spain.
authors: José-Bruno
authors: JB
authors: Montoro-Ronsano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D057966:Calcimimetic Agents / Q000627:therapeutic use*; D002118:Calcium / Q000097:blood; D000069449:Cinacalcet / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D056687:Off-Label Use; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D057966:Calcimimetic Agents; D010281:Parathyroid Hormone; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet