Back to Journals » Neuropsychiatric Disease and Treatment » Volume 8

Long-term tolerability of once-monthly injectable paliperidone palmitate in subjects with recently diagnosed schizophrenia

Authors Sliwa, Bossie CA, Fu, Turkoz I, Alphs L

Received 3 April 2012

Accepted for publication 20 May 2012

Published 27 August 2012 Volume 2012:8 Pages 375—385

DOI https://doi.org/10.2147/NDT.S32581

Review by Single-blind

Peer reviewer comments 3


Video abstract presented by Jennifer Kern Sliwa

Views: 4059

Jennifer Kern Sliwa,1 Cynthia A Bossie,1 Dong-Jing Fu,1 Ibrahim Turkoz,2 Larry Alphs1

1Janssen Scientific Affairs LLC, 2Janssen Research and Development, LLC, Titusville, NJ, USA

Background: A post hoc analysis from a multiphase trial with open-label transition and maintenance phases, a double-blind relapse prevention phase, and an optional open-label extension examined the long-term tolerability with continuous once-monthly injectable paliperidone palmitate 39, 78, 117, or 156 mg (25, 50, 75, or 100 mg equivalents [mg eq] of paliperidone) in subjects with recently diagnosed (≤5 years; n = 216) versus chronic illness (>5 years; n = 429) schizophrenia.
Methods: Adverse events reported at a ≥2% margin between subgroups were identified. Relative risks (in the recently diagnosed compared with the chronically ill) and 95% confidence intervals (CI) were determined, and CI not including 1 were considered potentially significant.
Results: In both subgroups, the mean monthly dose was 109 mg (69.9 mg eq). Continuous mean exposures were 333.9 ± 271.9 and 308.7 ± 278.3 days in the recently diagnosed and chronic illness subgroups, respectively. Using the criteria outlined in the methods, nasopharyngitis was a potentially significant event reported in more chronically ill than recently diagnosed subjects at months 6, 9, 12, and endpoint (7.2% versus 2.8%; relative risk 0.384; 95% CI 0.163–0.907). Influenza (2.8% versus 0.7%; relative risk 3.9; 95% CI 1.003–15.730) and amenorrhea (3.2% versus 0.9%; relative risk 3.476; 95% CI 1.029–11.744) at endpoint were potentially significant events in more recently diagnosed than chronically ill subjects. Mean weight changes, sedation/somnolence, any extrapyramidal symptom-related or glucose-related events were generally similar between the groups. The mean prolactin level increased in both sexes in both subgroups (changes from baseline of +41.8 ng/mL and +26.5 ng/mL in recently diagnosed and chronic illness females and +12.3 ng/mL and +15.1 ng/mL in recently diagnosed and chronic illness males, respectively), and were higher in females with recently diagnosed illness than in females who were chronically ill (P = 0.0002 at endpoint). Prolactin-related events were reported by 7.9% of recently diagnosed subjects with schizophrenia and 3.5% of those who were chronically ill.
Conclusion: The long-term tolerability of paliperidone palmitate was generally similar in recently diagnosed schizophrenia subjects and those with more chronic illness, with the exception of some prolactin-related measures.

Keywords: paliperidone palmitate, long-acting antipsychotic, recently diagnosed, early illness, schizophrenia

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]