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P03-127 - A Flexible-Dose Study of Paliperidone ER in Non-Acute Patients with Schizophrenia Previously Unsuccessfully Treated with Other Oral Antipsychotics

Published online by Cambridge University Press:  17 April 2020

A. Schreiner ,
D. Hoeben ,
M. Lahaye ,
C. Tessier ,
J. Peuskens ,
F. Nardini ,
W. Albrecht ,
M. Jakovljevic  and
S. Djukic-Dejanovic
A. Schreiner
Affiliation:
EMEA Medical Affairs, Janssen-Cilag, Neuss, Germany
D. Hoeben
Affiliation:
EMEA Medical Affairs, Janssen Pharmaceutica N.V., Beerse, Belgium
M. Lahaye
Affiliation:
Janssen Cilag Netherlands B.V., Tilburg, The Netherlands
C. Tessier
Affiliation:
EMEA Medical Affairs, Janssen Cilag France, Paris, France
J. Peuskens
Affiliation:
University Psychiatric Centre St.-Jozef, Kortenberg, Belgium
F. Nardini
Affiliation:
Dip. di Psichiatria, Neurobiologia, Farmacologia e Biotecnologie, Università di Pisa, Pisa, Italy
W. Albrecht
Affiliation:
Private Practice, Ellwangen, Germany
M. Jakovljevic
Affiliation:
Psychiatry, Clinical Hospital Centre Zagreb, Zagreb, Croatia
S. Djukic-Dejanovic
Affiliation:
Clinic for Psychiatry, Clinical Center Kragujevac, Kragujevac, Serbia

Abstract

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Objective

To explore tolerability, safety and treatment response of flexible doses of paliperidone ER in adult non-acute patients with schizophrenia previously unsuccessfully treated with oral antipsychotics.

Methods

International prospective 6-month open-label study. Endpoints were the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity Scale (CGI-S), patient satisfaction, adverse events (AEs), extrapyramidal symptoms (Extrapyramidal Symptom Rating Scale; ESRS) and weight change.

Results

1812 patients were included (59.9% male, mean age 40.1±12.6 years, 75.8% paranoid schizophrenia); most were enrolled because of lack of efficacy (n=1026) or lack of tolerability (n=490) with prior antipsychotic treatment. The median mode dose of paliperidone ER was 6 mg/day. 70.7% of patients completed the 6-month study. Most frequent reasons for early discontinuation were patient choice (8.8%), lack of efficacy or adverse event (5.1% each) independent of the reason for switching. Mean total PANSS decreased significantly from 79.4±20.4 at baseline to 66.1±21.5 at endpoint (mean change -13.3±19.7; 95% confidence interval -14.2;-12.3, p< 0.0001). The percentage of patients rated mildly ill or less in CGI-S increased from 27.0% to 52.2% at endpoint, and the rate of patients with mild functional impairment increased from 15.8% to 34.9%. AEs reported in greater-than-or-equal-to 5% of patients were insomnia (9.2%) and anxiety (7.2%). Extrapyramidal symptoms in ESRS decreased significantly from 3.5±5.8 to 2.1±4.6 (p< 0.0001). Mean weight gain from baseline to endpoint was 0.3±4.8kg.

Conclusion

These data support results from recent randomized controlled studies that paliperidone ER is safe, well tolerated and effective in patients previously unsuccessfully treated with other oral antipsychotics.

Type
Psychotic disorders / Schizophrenia
Information
European Psychiatry , Volume 25 , Issue S1: 18th European Congress of Psychiatry. February 27, March 2, 2010 - Munich, Germany , 2010 , 25-E1096
Copyright
Copyright © European Psychiatric Association 2010
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