Background
Paliperidone extended-release tablet (paliperidone ER; Invega, Janssen L.P., Titusville,
New Jersey) is an oral psychotropic for schizophrenia treatment.
Methods
Efficacy and safety of once-daily paliperidone ER (6 and 12 mg) were assessed versus
placebo in 444 patients with acute schizophrenia in a 6-week, multicenter, double-blind,
randomized, parallel-group study. An olanzapine (10 mg) treatment arm was included
to confirm trial validity.
Results
Both doses of paliperidone ER demonstrated significant improvement in Positive and
Negative Syndrome Scale (PANSS) total score (p ≤ .006) and certain PANSS Marder factor scores compared with placebo (p ≤ .025); PANSS total score also improved in the olanzapine treatment arm. Paliperidone
ER 6 mg (p ≤ .008), but not 12 mg, was associated with significant improvements in personal
and social performance. The incidence of treatment-emergent adverse events (AEs) for
paliperidone ER 6 mg was comparable with placebo and slightly greater with paliperidone
ER 12 mg. Changes in blood glucose and lipid levels with paliperidone ER were comparable
with placebo. Two patients treated with paliperidone ER experienced glucose-related
AEs. Body-weight increases of 1-2 kg were observed with paliperidone ER. Although
there were increases in plasma prolactin levels with paliperidone ER treatment, the
incidence of prolactin-related AEs was ≤1%.
Conclusions
In this study, paliperidone ER, particularly the 6-mg dose, was effective and well
tolerated, and provides a valuable new treatment option for schizophrenia.
Key Words
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Article info
Publication history
Published online: June 30, 2007
Accepted:
January 29,
2007
Received in revised form:
January 10,
2007
Received:
October 2,
2006
Identification
Copyright
© 2007 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.
