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Int J Clin Pharmacol Ther. 2010 Jun;48(6):383-99.

Efficacy and tolerability of paliperidone ER and other oral atypical antipsychotics in schizophrenia.

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Psychology Department, Macquarie University, Australia.


Atypical antipsychotics are widely used in the pharmacologic management of schizophrenia. Information to guide evidence-based clinical decision making must be continually updated, particularly as new clinical trial data and new antipsychotic agents become available.


This meta-analysis of oral atypical antipsychotics assessed the relative effectiveness and tolerability profile of a recently introduced agent, paliperidone extended-release (ER), to determine its place within the efficacy and tolerability spectrum of the labeled dose ranges of other oral atypical antipsychotics.


Randomized placebo-controlled studies of risperidone, olanzapine, quetiapine, and aripiprazole were identified via database search (MEDLINE, EMBASE, Cochrane Library, PsycInfo, and Cumulative Index to Nursing & Allied Health Literature). Baseline demographic, efficacy, and safety data were extracted and combined in meta-analysis. Random effects meta-regression assessed potential confounding by patient mean age, gender ratio, and duration of therapy on variability in efficacy and safety.


Within the spectrum of efficacy and safety of the class, paliperidone ER demonstrated a novel efficacy-tolerability profile versus the other oral atypical antipsychotics, including lower odds of withdrawal for any reason and less weight gain. Odds of withdrawal due to adverse events were lower with paliperidone ER compared with risperidone and with atypical antipsychotics as a class. Paliperidone ER was associated with lower odds of somnolence and agitation than the atypical class as a whole and with lower odds of weight gain than all of the atypical antipsychotics, including risperidone. The main factor in the observed variability in efficacy results between studies was the antipsychotic, rather than patient-related factors or duration of therapy.


Paliperidone ER is an effective and well-tolerated oral atypical antipsychotic that provides an important new treatment option for patients with schizophrenia. Owing to the heterogeneity within the class, information on individual benefit/risk profiles of antipsychotics is necessary for selecting an appropriate treatment for each patient.

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