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- Title
Incidence of tardive dyskinesia: a comparison of long-acting injectable and oral paliperidone clinical trial databases.
- Authors
Gopal, S.; Xu, H.; Bossie, C.; Burón, J. A.; Fu, D. J.; Savitz, A.; Nuamah, I.; Hough, D.
- 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.
- Publication
International Journal of Clinical Practice, 2014, Vol 68, Issue 12, p1514
- ISSN
1368-5031
- Publication type
Article
- DOI
10.1111/ijcp.12493