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Drug information update: paliperidone palmitate for schizophrenia

  • Abraham M. Nussbaum (a1) (a2) and T. Scott Stroup (a3)
Abstract
Aims and method

To review the evidence for the use of paliperidone palmitate for people with schizophrenia and schizophrenia-like illnesses. We searched the Cochrane Schizophrenia Group Specialised Register and contacted the manufacturer of paliperidone palmitate, the US Food and Drug Administration, and the authors of papers that reported study results.

Results

Based on the evidence from five short-term, placebo-controlled studies, paliperidone palmitate is efficacious as an antipsychotic. Its adverse effects are similar to those of the closely related compounds paliperidone and risperidone. Extrapyramidal side-effects, weight gain and tachycardia are more common with paliperidone palmitate than placebo. Paliperidone palmitate was associated with substantial increases in serum prolactin but not with increased sexual side-effects in these studies. In two studies paliperidone palmitate was similar to depot risperidone.

Clinical implications

Paliperidone palmitate is an effective antipsychotic whose optimal dose appears to be between 39 and 234 mg every 4 weeks. We have no data assessing its long-term effectiveness or comparing it with any long-acting injected antipsychotic other than depot risperidone.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution (CC-BY) license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author
Abraham M. Nussbaum (abraham.nussbaum@dhha.org)
Footnotes
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Declaration of interest

A.M.N. receives funding from the University of Chicago Program on Medicine and Religion for unrelated projects. T.S.S. receives funding from Agency for Healthcare Research and Quality and the National Institute of Mental Health for unrelated projects.

Footnotes
References
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1 Freedman, R. Schizophrenia. N Engl J Med 2003; 349: 1738–49.
2 Lieberman, JA, Stroup, TS, McEvoy, JP, Swartz, MS, Rosenheck, RA, Perkins, DO, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005; 353: 1209–23.
3 McEvoy, JP. Risks versus benefits of different types of long-acting injectable antipsychotics. J Clin Psych 2006; 67: 15–8.
4 Janssen Pharmaceutica Products LP. Risperdal Consta (Risperidone) Long-Acting Injection Prescribing Information. Janssen Pharmaceutica Products LP, 2003.
5 Fang, J, Bourin, M, Baker, GB. Metabolism of risperidone to 9-hydroxyrisperidone by human cytochromes P450 2D6 and 3A4. Naunyn Schmiedebergs Arch Pharmacol 1999; 359: 147–51.
6 Nussbaum, AM, Stroup, TS. Oral paliperidone for schizophrenia. Cochrane Database Syst Rev 2009; CD006369.
7 Janssen. Invega Sustenna (Paliperidone Palmitate) Extended-Release Injectable Suspension Prescribing Information. Orth-McNeil-Janssen Pharmaceuticals, 2009.
8 Nussbaum, AM, Stroup, TS. Paliperidone palmitate for schizophrenia. Cochrane Database Syst Rev 2012; CD008296.
9 Gopal, S, Hough, DW, Xu, H, Lull, JM, Gassmann-Mayer, C, Remmerie, BM, et al. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol 2010; 25: 247–56.
10 Hough, D, Gopal, S, Vijapurkar, U, Lim, P, Morozova, M, Eerdekens, M. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res 2010; 116: 107–17.
11 Kramer, M, Litman, R, Hough, D, Lane, R, Lim, P, Liu, Y, et al. Paliperidone palmitate, a potential long-acting treatment for patients with schizophrenia. Results of a randomized, double-blind, placebo-controlled efficacy and safety study. Int J Neuropsychopharmacol 2009; 13: 635–47.
12 Nasrallah, HA, Gopal, S, Gassmann-Mayer, C, Quiroz, JA, Lim, P, Eerdekens, M, et al. A controlled, evidence-based trial of paliperidone palmitate, a long-acting injectable antipsychotic, in schizophrenia. Neuropsychopharmacol 2010; 10: 2072–82.
13 Pandina, GJ, Lindenmayer, JP, Lull, J, Lim, P, Gopal, S, Herben, V, et al. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol 2010; 30: 235–44.
14 Fleischhacker, WW, Gopal, S, Lane, R, Gassmann-Mayer, C, Lim, P, Hough, D, et al. A randomized trial of paliperidone palmitate and risperidone long-acting injectable in schizophrenia. Int J Neuropsychopharmacol 2011; Jul 22: 112. (Epub ahead of print.).
15 Pandina, G, Lane, R, Gopal, S, Gassmann-Mayer, C, Hough, D, Remmerie, B, et al. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry 2011; 35: 218–26.
16 Nussbaum, AM, Stroup, TS. Paliperidone palmitate for schizophrenia. Schiz Bull 2012; 38: 1124–7.
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BJPsych Bulletin
  • ISSN: 1758-3209
  • EISSN: 1758-3217
  • URL: /core/journals/bjpsych-bulletin
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Drug information update: paliperidone palmitate for schizophrenia

  • Abraham M. Nussbaum (a1) (a2) and T. Scott Stroup (a3)
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