title: Effect of VDRA on survival in incident hemodialysis patients: results of the FARO-2 observational study.
abstract: BACKGROUND
  Mortality rate among patients with stage five chronic kidney disease (CKD) maintained on hemodialysis (HD) is high. Although evidence suggests that use of Vitamin D Receptor Activators (VDRA) in CKD patients increases survival, few studies have examined the effect of VDRA in incident HD patients. The FARO-2 study evaluated the clinical outcome of VDRA therapy on mortality in incident HD patients.
  
  
  METHODS
  FARO-2 was a longitudinal epidemiological study performed on 568 incident HD patients followed prospectively from 26 dialysis centers over a 3-year period. Data were collected every 6 months using a questionnaire, obtaining clinical, biochemical and therapeutic parameters. Kaplan-Meier curves and Cox proportional hazard regression models were used to determine cumulative probability of time-to-death and adjusted hazard ratios.
  
  
  RESULTS
  568 patients (68% male) with an average age of 65.5 years were followed up. Mean dialysis duration at study entry was 3 months. VDRA use increased from 46% at 6 months to 54.7% at 36 months of follow-up (p = 0.08). No difference was observed in the presence of comorbid diseases at baseline in patients with and without VDRA therapy. Cumulative probability of survival at 24 months was 74.5% (95% CI: 70.2-78.3). Patients receiving VDRA therapy showed a significant increase in survival at 24 months (80.7%; 95% CI: 75.7-84.8) compared to those without (63.3%; 95% CI: 54.8-70.7, p <0.01). The presence of vascular disease, decreased hemoglobin, increased P and lack of VDRA treatment were significantly associated with an increased risk of mortality. Lack of VDRA treatment still remained significant as a predictor of mortality after adjusting for levels of PTH, P and Ca (HR = 2.16, 95% CI: 1.09-4.30, p = 0.03).
  
  
  CONCLUSIONS
  Findings from FARO-2 indicate that in incident HD patients VDRA therapy was associated with increased survival.
authors.affiliation: Nephrology, Dialysis and renal Transplant, Fondazione Ca' Granda IRCCS-Policlinico, Milan, Italy. pmessa@policlinico.mi.it.
authors.forename: Piergiorgio
authors.initials: P
authors.lastname: Messa
authors.affiliation: Department of Health Sciences, University of Milan - Renal Division - San Paolo Hospital, Milan, Italy. mario.cozzolino@unimi.it.
authors.forename: Mario
authors.initials: M
authors.lastname: Cozzolino
authors.affiliation: Dialysis Unit, "Simone Martini", Milan, Italy. diego.brancaccio@tiscali.it.
authors.forename: Diego
authors.initials: D
authors.lastname: Brancaccio
authors.affiliation: Department of Nephrology, San Martino Hospital, Genoa, Italy. cannpino@gmail.com.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cannella
authors.affiliation: Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona, Italy. f.malberti@ospedale.cremona.it.
authors.forename: Fabio
authors.initials: F
authors.lastname: Malberti
authors.affiliation: AbbVie Italy, Campoverde, Latina, Italy. annamaria.costanzo@abbvie.com.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Costanzo
authors.affiliation: AbbVie Italy, Campoverde, Latina, Italy. umberto.paparatti@abbvie.com.
authors.forename: Umberto
authors.initials: U
authors.lastname: di Luzio Paparatti
authors.affiliation: AbbVie Italy, Campoverde, Latina, Italy. vincenzo.Festa@abbvie.com.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Festa
authors.affiliation: AbbVie Italy, Campoverde, Latina, Italy. giuliana.gualberti@abbvie.com.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Gualberti
authors.affiliation: Dipartimento di Scienze Cardiovascolari Respiratorie Nefrologiche e Geriatriche, Sapienza Università di Roma, Roma, Italy. sandro.mazzaferro@uniroma1.it.
authors.forename: Sandro
authors.initials: S
authors.lastname: Mazzaferro
mesh_terms: D000368:Aged; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D007677:Kidney Function Tests; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D018167:Receptors, Calcitriol / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000379:methods*; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality* / Q000628:therapy; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D018167:Receptors, Calcitriol