Open AccessIncidence of tardive dyskinesia: a comparison of long‐acting injectable and oral paliperidone clinical trial databases
Author(s) -
Gopal S.,
Xu H.,
Bossie C.,
Burón J. A.,
Fu D. J.,
Savitz A.,
Nuamah I.,
Hough D.
Publication year - 2014
Publication title -
international journal of clinical practice
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.756
H-Index - 98
eISSN - 1742-1241
pISSN - 1368-5031
DOI - 10.1111/ijcp.12493
Subject(s) - medicine , tardive dyskinesia , paliperidone , schizophrenia (object oriented programming) , dyskinesia , paliperidone palmitate , adverse effect , incidence (geometry) , post hoc analysis , tolerability , pediatrics , psychiatry , antipsychotic , physics , disease , parkinson's disease , optics
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 (< 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.