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Summary   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 ( AE s) 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 (&lt; 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.

Incidence of tardive dyskinesia: a comparison of long‐acting injectable and oral paliperidone clinical trial databases