title: A pragmatic analysis comparing once-monthly paliperidone palmitate versus daily oral antipsychotic treatment in patients with schizophrenia.
abstract: BACKGROUND
  Persons with schizophrenia often come in contact with the criminal justice system (CJS). This analysis of subjects with schizophrenia and a history of contact with the CJS estimated and compared mean cumulative function (MCF) of treatment failure events when treated with paliperidone palmitate (PP) or oral antipsychotics (OAs). All events identified during the full study period of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) trial were evaluated.
  
  
  METHODS
  Subjects were randomly assigned to flexibly dosed, monthly, injectable PP (78-234 mg) or daily OA in a 15-month prospective, open-label, multicenter US study (May 5, 2010-December 9, 2013). Subjects could continue participation after a treatment failure event. Multiple treatment failures in individual subjects were analyzed as recurrent events. Analyses estimated MCF of treatment failure events and MCF of institutionalizations (arrests, incarcerations, or psychiatric hospitalizations) during the 15-month study period.
  
  
  RESULTS
  The ITT population included 226 (PP) and 218 (OA) subjects, of whom 41.2% and 40.4%, respectively, completed 15 months of follow-up. The MCF of treatment failures and institutionalizations differed significantly in favor of PP compared with OA (P=0.007 and P=0.005, respectively). Overall, TEAEs were reported by 86.3% of subjects in the PP group and 81.7% in the OA group.
  
  
  CONCLUSIONS
  This pragmatic analysis suggests that, compared with OA, PP is not only more effective in delaying median time to treatment failure, but it also reduces the number of treatment failures and institutionalizations per person-year follow-up.
  
  
  BACKGROUND
  Clinicaltrials.gov identifier: NCT01157351.
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, NJ, United States. Electronic address: lalphs@its.jnj.com.
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
authors.affiliation: Janssen Research and Development, Titusville, NJ, United States.
authors.forename: Lian
authors.initials: L
authors.lastname: Mao
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, NJ, United States.
authors.forename: H
authors.initials: H
authors.lastname: Lynn Starr
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, NJ, United States.
authors.forename: Carmela
authors.initials: C
authors.lastname: Benson
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D007326:Institutionalization; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012559:Schizophrenia / Q000188:drug therapy*; D017211:Treatment Failure; D014481:United States; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D000068882:Paliperidone Palmitate
keywords: Oral antipsychotics; Paliperidone palmitate; Pragmatic analysis; Pride