title: Incidence of tardive dyskinesia: a comparison of long-acting injectable and oral paliperidone clinical trial databases.
abstract: BACKGROUND
  To assess the tardive dyskinesia (TD) rate in studies of once-monthly long-acting injectable (LAI) paliperidone palmitate (PP) and once-daily oral paliperidone extended release (Pali ER).
  
  
  METHODS
  Completed schizophrenia and bipolar studies for PP and Pali ER (≥ 6 month duration with retrievable patient-level data) were included in this post hoc analysis. Schooler-Kane research criteria were applied using Abnormal Involuntary Movement Scale (AIMS) scores to categorise probable (qualifying AIMS scores persisting for ≥ 3 months) and persistent TD (score persisting ≥ 6 months). Spontaneously reported TD adverse events (AEs) were also summarised. Impact of exposure duration on dyskinesia (defined as AIMS total score ≥ 3) was assessed by summarising the monthly dyskinesia rate.
  
  
  RESULTS
  In the schizophrenia studies, TD rates for PP (four studies, N = 1689) vs. Pali ER (five studies, N = 2054), were: spontaneously reported AE, 0.18% (PP) vs. 0.10% (Pali ER); probable TD, 0.12% (PP) vs. 0.19% (Pali ER) and persistent TD, 0.12% (PP) vs. 0.05% (Pali ER). In the only bipolar study identified [Pali ER (N = 614)], TD rate was zero (spontaneously reported AE reporting, probable and persistent TD assessments). Dyskinesia rate was higher within the first month of treatment with both PP (13.1%) and Pali ER (11.7%) and steadily decreased over time (months 6-7: PP: 5.4%; Pali ER: 6.4%). Mean exposure: PP, 279.6 days; Pali ER, 187.2 days.
  
  
  CONCLUSIONS
  Risk of TD with paliperidone was low (< 0.2%), regardless of the formulation (oral or LAI), in this clinical trial dataset. Longer cumulative exposure does not appear to increase the risk of dyskinesias.
authors.affiliation: Janssen Research & Development, LLC, Titusville, NJ, USA.
authors.forename: S
authors.initials: S
authors.lastname: Gopal
authors.forename: H
authors.initials: H
authors.lastname: Xu
authors.forename: C
authors.initials: C
authors.lastname: Bossie
authors.forename: J A
authors.initials: JA
authors.lastname: Burón
authors.forename: D J
authors.initials: DJ
authors.lastname: Fu
authors.forename: A
authors.initials: A
authors.lastname: Savitz
authors.forename: I
authors.initials: I
authors.lastname: Nuamah
authors.forename: D
authors.initials: D
authors.lastname: Hough
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009069:Movement Disorders / Q000188:drug therapy / Q000453:epidemiology* / Q000209:etiology; D000068882:Paliperidone Palmitate / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D012008:Recurrence; D018967:Risperidone / Q000009:adverse effects* / Q000627:therapeutic use; D012559:Schizophrenia / Q000188:drug therapy; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D018967:Risperidone; D000068882:Paliperidone Palmitate