Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics.
OBJECTIVE
This study explores relevant outcomes with flexibly dosed paliperidone extended-release (ER) in a real-world design.


METHODS
Patients were recruited from 23 countries. Adults with non-acute schizophrenia (n = 1812), previously unsuccessfully treated with other oral antipsychotics, were transitioned to paliperidone ER and prospectively treated for 6 months.


METHODS
Primary efficacy outcome for patients switching for the main reason of lack of efficacy was ≥ 20% improvement in Positive and Negative Syndrome Scale (PANSS) total scores. For patients switching for main reasons other than lack of efficacy, primary outcome was non-inferiority in efficacy compared with the previous medication.


RESULTS
Among the lack-of-efficacy group, 61% achieved a ≥ 20% improvement in PANSS total scores from baseline to endpoint. For switchers from other than the lack-of-efficacy group, efficacy maintenance after switching to paliperidone ER was confirmed. Clinically relevant and statistically significant symptomatic improvements occurred for each patient group based on main reason for switching.


CONCLUSIONS
Paliperidone ER was well tolerated and associated with a meaningful clinical response in patients who switched from other oral antipsychotics, with insomnia and anxiety as most frequent side-effects.
Medical & Scientific Affairs Europe, Middle East & Africa, Janssen-Cilag GmbH , Johnson & Johnson Platz 5a, 41470 Neuss , Germany +49 2137 955 153 ; +49 2137 955 92 5481 ; aschrein@its.jnj.com.
Andreas
A
Schreiner
Marjolein
M
Lahaye
Joseph
J
Peuskens
Dieter
D
Naber
Nesrin
N
Dilbaz
Bruno
B
Millet
Manuel A
MA
Franco
Elmars
E
Rancans
Jacek
J
Turczynski
Enrico
E
Smeraldi
Elsa
E
Lara
Nikolaj G
NG
Neznanov
D000284:Administration, Oral; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000139:chemically induced; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D000068882:Paliperidone Palmitate; D011446:Prospective Studies; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced
D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D011743:Pyrimidines; D000068882:Paliperidone Palmitate