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: S Gopal, H Xu, C Bossie, J A Burón, D J Fu, A Savitz, I Nuamah, D Hough
• Journal: International journal of clinical practice (Int J Clin Pract) Vol. 68 Issue 12 Pg. 1514-22 (Dec 2014) ISSN: 1742-1241 [Electronic] India
• PMID: 25358867 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

Chemical References

• Antipsychotic Agents
• Delayed-Action Preparations
• Risperidone
• Paliperidone Palmitate

Topics

• Adult
• Antipsychotic Agents (administration & dosage, adverse effects, therapeutic use)
• Delayed-Action Preparations (administration & dosage, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Male
• Middle Aged
• Movement Disorders (drug therapy, epidemiology, etiology)
• Paliperidone Palmitate (adverse effects, pharmacology, therapeutic use)
• Recurrence
• Risperidone (adverse effects, therapeutic use)
• Schizophrenia (drug therapy)
• Treatment Outcome