title: Effectiveness and safety of a 6-month treatment with paricalcitol in patients on hemodialysis with secondary hyperparathyroidism.
abstract: The mineral bone disorder, particularly secondary hyperparathyroidism, in chronic kidney disease (CKD) has a systemic impact affecting not only bone metabolism. Therefore its correction is important to prevent cardiovascular, inflammatory and immune diseases.
  
  
  
  To assess the effectiveness and safety of intravenous paricalcitol administered over a 6 month period for the treatment of secondary hyperparathyroidism (SHPT) in patients undergoing conventional hemodialysis, with close follow-up of treatment response.
  
  
  
  A phase 4 clinical trial was performed comparing clinical and laboratory data before and after 6 months of treatment. SHPT patients undergoing hemodialysis who were naïve to vitamin D metabolites or had failed to current therapy were included. Clinical and laboratory characteristics were analyzed. Efficacy analyses were based on intact parathyroid hormone (iPTH) levels and were performed using data from patients who completed 6 months of treatment.
  
  
  
  Nineteen of the 26 patients enrolled completed 6 months of treatment. All patients exhibited reduced baseline iPTH levels (mean reduction, 371.8 pg/mL; 95% CI, 273.3-470.2 pg/mL]; 17 patients (89.5%) had reductions exceeding 30%. Twelve patients (63%) achieved therapeutic success (defined as iPTH serum levels 150-300 pg/mL), with a median time of 2 months from the beginning of treatment. All reported episodes of hypercalcemia (n = 2) and hyperphosphatemia (n = 34) were asymptomatic. No major therapy-related serious AEs were reported.
  
  
  
  Paricalcitol was safely administered and was associated with significant decreases in iPTH levels over the study period.
authors.affiliation: Servicio Asistencial Renal Integral (SARI).
authors.forename: Inés
authors.initials: I
authors.lastname: Olaizola
authors.affiliation: Centro de Nefrología Renis (RENIS).
authors.forename: Hena
authors.initials: H
authors.lastname: Caorsi
authors.affiliation: Centro de Diálisis Uruguayana.
authors.forename: Laura
authors.initials: L
authors.lastname: Fajardo
authors.affiliation: Asociación Médica de San José and Centro de Nefrología de la Facultad de Medicina.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Ferreiro
authors.affiliation: Centro de Diálisis Uruguayana.
authors.forename: Nieves
authors.initials: N
authors.lastname: Campistrus
authors.affiliation: AbbVie.
authors.forename: Deyanira
authors.initials: D
authors.lastname: Dolinsky
authors.affiliation: Servicio Asistencial Renal Integral (SARI).
authors.forename: Alicia
authors.initials: A
authors.lastname: Petraglia
authors.affiliation: Centro de Nefrología Renis (RENIS).
authors.forename: Pablo
authors.initials: P
authors.lastname: Ambrosoni
mesh_terms: D000368:Aged; D004872:Ergocalciferols / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy*; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D004872:Ergocalciferols; C084656:paricalcitol