Profile of paliperidone extended release: review of efficacy and safety data

References

• Carpenter WT, Buchanan RW. Lessons to take home from CATIE. Psychiatr. Serv.59(5), 523–525 (2008).
   PubMed Web of Science ®Google Scholar
• Johnsen E, Jørgensen HA. Effectiveness of second generation antipsychotics: a systematic review of randomized trials. BMC Psychiatry8, 31 (2008).
   PubMed Web of Science ®Google Scholar
• Lieberman JA. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia: efficacy, safety and cost outcomes of CATIE and other trials. J. Clin. Psychiatry68(2), E04 (2007).
   PubMedGoogle Scholar
• Lautenschlager M, Heinz A. Paliperidone-ER: first atypical antipsychotic with oral extended release formulation. Expert Rev. Neurother.8(2), 193–200 (2008).
   PubMedGoogle Scholar
• Owen RT. Extended-release paliperidone: efficacy, safety and tolerability profile of a new atypical antipsychotic. Drugs Today (Barc.)43(4), 249–258 (2007).
   PubMed Web of Science ®Google Scholar
• Spina E, Cavallaro R. The pharmacology and safety of paliperidone extended-release in the treatment of schizophrenia. Expert Opin. Drug Saf.6(6), 651–662 (2007).
   PubMed Web of Science ®Google Scholar
• Conley R, Gupta SK, Sathyan G. Clinical spectrum of the osmotic-controlled release oral delivery system (OROS), an advanced oral delivery form. Curr. Med. Res. Opin.22(10), 1879–1892 (2006).
   PubMed Web of Science ®Google Scholar
• Shayegan DK, Stahl SM. Atypical antipsychotics: matching receptor profile to individual patient’s clinical profile. CNS Spectr.9(10 Suppl. 11), 6–14 (2004).
   PubMed Web of Science ®Google Scholar
• Pani L, Pira L, Marchese G. Antipsychotic efficacy: relationship to optimal D2-receptor occupancy. Eur. Psychiatry22(5), 267–275 (2007).
   PubMed Web of Science ®Google Scholar
• Karlsson P, Dencker E, Nyberg S et al. Pharmacokinetics, dopamine D2 and serotonin 5-HT2A receptor occupancy and safety profile of paliperidone extended-release in healthy subjects. Schizophr. Res.81(1), 85 (2006).
   Web of Science ®Google Scholar
• van Beijsterveldt LE, Geerts RJ, Leysen JE et al. Regional brain distribution of risperidone and its active metabolite 9-hydroxy-risperidone in the rat. Psychopharmacology (Berl.)114(1), 53–62 (1994).
   PubMed Web of Science ®Google Scholar
• Heykants J, Huang ML, Mannens G et al. The pharmacokinetics of risperidone in humans: a summary. J. Clin. Psychiatry55(Suppl.), 13–17 (1994).
   PubMed Web of Science ®Google Scholar
• Nesvåg R, Hendset M, Refsum H, Tanum L. Serum concentrations of risperidone and 9-OH risperidone following intramuscular injection of long-acting risperidone compared with oral risperidone medication. Acta Psychiatr. Scand.114(1), 21–26 (2006).
   PubMed Web of Science ®Google Scholar
• Mannens G, Huang ML, Meuldermans W, Hendrickx J, Woestenborghs R, Heykants J. Absorption, metabolism, and excretion of risperidone in humans. Drug Metab. Dispos.21(6), 1134–1141 (1993).
   PubMed Web of Science ®Google Scholar
• Urichuk L, Prior TI, Dursun S, Baker G. Metabolism of atypical antipsychotics: involvement of cytochrome P450 enzymes and relevance for drug–drug interactions. Curr. Drug Metab.9(5), 410–418 (2008).
   PubMed Web of Science ®Google Scholar
• Spina E, Avenoso A, Facciolà G et al. Plasma concentrations of risperidone and 9-hydroxyrisperidone: effect of comedication with carbamazepine or valproate. Ther. Drug Monit.22(4), 481–485 (2000).
   PubMed Web of Science ®Google Scholar
• Kane J, Canas F, Kramer M et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr. Res.90(1–3), 147–161 (2007).
   PubMed Web of Science ®Google Scholar
• Davidson M, Emsley R, Kramer M et al. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER) results of a 6-week, randomized, placebo-controlled study. Schizophr. Res.93(1–3), 117–130 (2007).
   PubMed Web of Science ®Google Scholar
• Marder SR, Kramer M, Ford L et al. Efficacy and safety of paliperidone extended-release tablets: results of a 6-week, randomized, placebo-controlled study. Biol. Psychiatry62(12), 1363–1370 (2007).
   PubMed Web of Science ®Google Scholar
• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr. Bull.13(2), 261–276 (1987).
   PubMed Web of Science ®Google Scholar
• Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R. Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr. Scand.101(4), 323–329 (2000).
   PubMed Web of Science ®Google Scholar
• Guy W. Clinical global impressions. In: ECDEU Assessment Manual for Psychopharmacology. National Institute for Mental Health. DHEW, MD, USA 217–222 (1976).
   Google Scholar
• Marder SR, Davis JM, Chouinard G. The effects of risperidone on the five dimensions of schizophrenia derived by factor analysis: combined results of the North American trials. J. Clin. Psychiatry58(12), 538–546 (1997); erratum in J. Clin. Psychiatry59(4), 200 (1998).
   PubMed Web of Science ®Google Scholar
• Luthringer R, Staner L, Noel N et al. A double-blind, placebo-controlled, randomized study evaluating the effect of paliperidone extended-release tablets on sleep architecture in patients with schizophrenia. Int. Clin. Psychopharmacol.22(5), 299–308 (2007); erratum in Int. Clin. Psychopharmacol.22(6), 387 (2007).
   PubMed Web of Science ®Google Scholar
• Nussbaum AM, Stroup TS. Paliperidone for treatment of schizophrenia. Schizophr. Bull.34(3), 419–422 (2008).
   PubMed Web of Science ®Google Scholar
• Kramer M, Simpson G, Maciulis V et al. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J. Clin. Psychopharmacol.27(1), 6–14 (2007); erratum in J. Clin. Psychopharmacol.27(3), 258 (2007).
   PubMed Web of Science ®Google Scholar
• Meltzer HY, Bobo WV, Nuamah IF et al. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J. Clin. Psychiatry69(5), 817–829 (2008).
   PubMed Web of Science ®Google Scholar
• Kramer M, Eerdekens M, Lane R et al. Oral paliperidone extended-release treatment: long-term metabolic outcomes in patients with schizophrenia. Schizophr. Res.98(Suppl. 1), 173–174 (2008).
   Google Scholar
• Eerdekens M, Kramer M, Rossenu S, Pandina G, Boom S. Effect of paliperidone extended-release tablets on prolactin exposure in patients with stable schizophrenia. Presented at: Psychiatric and Mental Health Congress. New Orleans, LA, USA 16–19 November 2006.
   Google Scholar
• Fitzgerald P, Dinan TG. Prolactin and dopamine: what is the connection? A review article. J. Psychopharmacol.22(2 Suppl.), 12–19 (2008).
   PubMedGoogle Scholar
• Knegtering R, Baselmans P, Castelein S, Bosker F, Bruggeman R, van den Bosch RJ. Predominant role of the 9-hydroxy metabolite of risperidone in elevating blood prolactin levels. Am. J. Psychiatry162(5), 1010–1012 (2005).
   PubMed Web of Science ®Google Scholar
• Berwaerts J, Cleton A, van de Vliet I et al. A randomized, open-label, single-center, crossover study of the potential effects of paroxetine on the pharmacokinetics of a single dose of paliperidone extended-release tablets in health subjects (poster). Presented at: 160th Annual Meeting of American Psychiatric Association. San Diego, CA, USA 19–24 May 2007.
   Google Scholar
• Tzimos A, Samokhvalov V, Kramer M et al. Safety and tolerability of oral paliperidone extended-release tablets in elderly patients with schizophrenia: a double-blind, placebo-controlled study with six-month open-label extension. Am. J. Geriatr. Psychiatry16(1), 31–43 (2008).
   PubMed Web of Science ®Google Scholar
• Canuso CM, Youssef EA, Bossie CA, Turkoz I, Schreiner A, Simpson GM. Paliperidone extended-release tablets in schizophrenia patients previously treated with risperidone. Int. Clin. Psychopharmacol.23(4), 209–215 (2008).
   PubMed Web of Science ®Google Scholar