title: Once-monthly paliperidone palmitate compared with conventional and atypical daily oral antipsychotic treatment in patients with schizophrenia.
abstract: OBJECTIVE
  This analysis of the Paliperidone Palmitate Research in Demonstrating Effectiveness (PRIDE) study (NCT01157351) compared outcomes after administration of once-monthly paliperidone palmitate (PP) vs conventional oral antipsychotics (COAs) or atypical oral antipsychotics (AOAs).
  
  
  METHODS
  PRIDE was a 15-month study of 444 individuals with schizophrenia and a history of incarceration. They were randomly assigned to PP or to 1 of 7 commonly prescribed OAs. Primary endpoint was time to first treatment failure (TF). Event-free probabilities were estimated using the Kaplan-Meier method; treatment group differences (PP vs COAs, PP vs AOAs, and PP vs oral paliperidone/risperidone) were assessed using a log-rank test. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models. No adjustment was made for multiplicity.
  
  
  RESULTS
  Compared with PP, risk for first TF was 34% higher with COAs (HR: 1.34; 95% CI: 0.80-2.25), 41% higher with AOAs (HR: 1.41; 95% CI: 1.06-1.88), and 39% higher with paliperidone/risperidone (HR: 1.39; 95% CI: 0.97-1.99). Incidences of extrapyramidal symptom-related adverse events (AEs) were 45.7%, 13.7%, and 10.6% in the COA, AOA, and oral paliperidone/risperidone groups vs 23.9% in the PP group. Incidences of prolactin-related AEs were 5.7%, 3.8%, and 3.5% vs 23.5%, and incidences of ≥7% weight increase were 11.4%, 14.9%, and 16.0% vs 32.4%.
  
  
  CONCLUSIONS
  Results suggest a lower risk of TF but a higher rate of some AEs after treatment with PP vs COAs, AOAs, and paliperidone/risperidone. Deselection of specific OAs and low patient-compliance rates with OAs likely biased the safety results.
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
authors.forename: Edward
authors.initials: E
authors.lastname: Kim
authors.affiliation: Hofstra Northwell School of Medicine, Hempstead, New York, USA.|Department of Psychiatry, The Zucker Hillside Hospital, Glen Oaks, New York, USA.
authors.forename: Christoph U
authors.initials: CU
authors.lastname: Correll
authors.affiliation: Janssen Research & Development, LLC, Titusville, New Jersey, USA.
authors.forename: Lian
authors.initials: L
authors.lastname: Mao
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
authors.forename: H Lynn
authors.initials: HL
authors.lastname: Starr
authors.affiliation: Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA.
authors.forename: Larry
authors.initials: L
authors.lastname: Alphs
mesh_terms: D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D000068180:Aripiprazole / Q000627:therapeutic use; D001480:Basal Ganglia Diseases / Q000139:chemically induced; D001569:Benzodiazepines / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005260:Female; D006220:Haloperidol / Q000627:therapeutic use; D006801:Humans; D006966:Hyperprolactinemia / Q000139:chemically induced; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D000077152:Olanzapine; D000068882:Paliperidone Palmitate / Q000008:administration & dosage* / Q000627:therapeutic use; D010546:Perphenazine / Q000627:therapeutic use; D016016:Proportional Hazards Models; D000069348:Quetiapine Fumarate / Q000627:therapeutic use; D018967:Risperidone / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D001569:Benzodiazepines; D000069348:Quetiapine Fumarate; D000068180:Aripiprazole; D010546:Perphenazine; D006220:Haloperidol; D018967:Risperidone; D000077152:Olanzapine; D000068882:Paliperidone Palmitate
keywords: Long-acting injectable antipsychotic; PRIDE; oral antipsychotic; paliperidone palmitate; schizophrenia