PMID- 25358867
OWN - NLM
STAT- MEDLINE
DCOM- 20160607
LR  - 20240322
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Print)
IS  - 1368-5031 (Linking)
VI  - 68
IP  - 12
DP  - 2014 Dec
TI  - Incidence of tardive dyskinesia: a comparison of long-acting injectable and oral 
      paliperidone clinical trial databases.
PG  - 1514-22
LID - 10.1111/ijcp.12493 [doi]
AB  - 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.
CI  - (c) 2014 The Authors. International Journal of Clinical Practice Published by John 
      Wiley & Sons Ltd.
FAU - Gopal, S
AU  - Gopal S
AD  - Janssen Research & Development, LLC, Titusville, NJ, USA.
FAU - Xu, H
AU  - Xu H
FAU - Bossie, C
AU  - Bossie C
FAU - Buron, J A
AU  - Buron JA
FAU - Fu, D J
AU  - Fu DJ
FAU - Savitz, A
AU  - Savitz A
FAU - Nuamah, I
AU  - Nuamah I
FAU - Hough, D
AU  - Hough D
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20141031
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - L6UH7ZF8HC (Risperidone)
RN  - R8P8USM8FR (Paliperidone Palmitate)
SB  - IM
MH  - Adult
MH  - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use
MH  - Delayed-Action Preparations/administration & dosage/therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Movement Disorders/drug therapy/*epidemiology/etiology
MH  - Paliperidone Palmitate/*adverse effects/pharmacology/therapeutic use
MH  - Recurrence
MH  - Risperidone/*adverse effects/therapeutic use
MH  - Schizophrenia/drug therapy
MH  - Treatment Outcome
PMC - PMC4265240
EDAT- 2014/11/02 06:00
MHDA- 2016/06/09 06:00
CRDT- 2014/11/01 06:00
PHST- 2014/02/27 00:00 [received]
PHST- 2014/06/09 00:00 [accepted]
PHST- 2014/11/01 06:00 [entrez]
PHST- 2014/11/02 06:00 [pubmed]
PHST- 2016/06/09 06:00 [medline]
AID - 10.1111/ijcp.12493 [doi]
PST - ppublish
SO  - Int J Clin Pract. 2014 Dec;68(12):1514-22. doi: 10.1111/ijcp.12493. Epub 2014 Oct 
      31.