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One-Year Open-Label Safety and Efficacy Study of Paliperidone Extended-Release Tablets in Patients With Schizophrenia

Published online by Cambridge University Press:  07 November 2014

Abstract

Introduction: This 52-week open-label extension (OLE) to a double-blind placebo-controlled recurrence prevention study examined the long-term safety and efficacy of flexibly-dosed paliperidone extended-release (ER) tablets in patients with schizophrenia.

Methods: Patients entering the OLE either entered from the double-blind phase (placebo or paliperidone ER treatment) or entered directly from the run-in or stabilization phase (paliperidone ER) of the earlier study. During the OLE, patients were treated with flexibly-dosed paliperidone ER (3–15 mg/day; 9 mg starting dose). Safety and tolerability assessments included incidence of adverse events and extrapyramidal symptoms. Efficacy was also assessed.

Results: The study population (n=235) was predominantly men (66%), 18–58 years of age. Twelve patients (5%) experienced an adverse event requiring treatment discontinuation. One or more serious treatment-emergent adverse events were reported in 13 patients (6%). There was one death. The mean Positive and Negative Syndrome Scale total score decreased from open-label baseline to endpoint for all groups, regardless of previous double-blind treatment (placebo or paliperidone ER).

Conclusion: This year-long OLE provides information on the long-term safety and tolerability of paliperidone ER in patients with schizophrenia. The resulting safety and tolerability profile was similar to that seen in earlier short-term studies.

Type
Original Research
Copyright
Copyright © Cambridge University Press 2010

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References

REFERENCES

1.Mancevski, B, Keilp, J, Kurzon, M, et al. Lifelong course of positive and negative symptoms in chronically institutionalized patients with schizophrenia. Psychopathology. 2007; 40(2): 8392.CrossRefGoogle ScholarPubMed
2.Valenstein, M, Ganoczy, D, McCarthy, JF, Myra Kim, H, Lee, TA, Blow, FC. Antipsychotic adherence over time among patients receiving treatment for schizophrenia: a retrospective review. J Clin Psychiatry. 2006; 67(10): 15421550.CrossRefGoogle ScholarPubMed
3.Liu-Seifert, H, Adams, DH, Kinon, BJ. Discontinuation of treatment of schizophrenic patients is driven by poor symptom response: a pooled post-hoc analysis of four atypical antipsychotic drugs. BMC Med. 2005; 3: 21.CrossRefGoogle ScholarPubMed
4.Yamada, K, Watanabe, K, Nemoto, N, et al. Prediction of medication noncompliance in outpatients with schizophrenia: 2-year follow-up study. Psychiatry Res. 2006; 141(1): 6169.Google Scholar
5.Cooper, C, Bebbington, P, King, M, et al. Why people do not take their psychotropic drugs as prescribed: results of the 2000 National Psychiatric Morbidity Survey. Acta Psychiatr Scand. 2007; 116(1): 4753.Google Scholar
6.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. 2006; 81(Suppl 1): 8586.Google Scholar
7.Kane, J, Canas, F, Kramer, M, et al. Treatment of schizophrenia with paliperidone extended-release tablets: a 6-week placebo-controlled trial. Schizophr Res. 2007; 90(1–3): 147161.Google Scholar
8.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. 2007; 93(1–3): 117130.Google Scholar
9.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. 2007; 27(1): 614.Google Scholar
10.Kay, SR, Fiszbein, A, Opler, LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987; 13(2): 261276.Google Scholar
11.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 Psychiatry. 1997; 58(12): 538546.Google Scholar
12.Kane, JM, Lauriello, J, Laska, E, et al. Long-term efficacy and safety of iloperidone: results from 3 clinical trials for the treatment of schizophrenia. J Clin Psychopharmacol. 2008; 28(2 Suppl 1): S29–S35.Google Scholar
13.Kane, JM. Pharmacologic treatment of schizophrenia. Biol Psychiatry. 1999; 46(10): 13961408.CrossRefGoogle ScholarPubMed