One-year open-label safety and efficacy study of paliperidone extended-release tablets in patients with schizophrenia.
BACKGROUND
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).


CONCLUSIONS
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.
Kramer
Michelle
M
Johnson & Johnson Pharmaceutical Research & Development; L.L.C. Raritan, USA.
Simpson
George
G
Maciulis
Valentinas
V
Kushner
Stuart
S
Liu
Yanning
Y
Lim
Pilar
P
Hough
David
D
Palumbo
Joseph
J
Eerdekens
Mariëlle
M
D014150:Antipsychotic Agents / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use; D000068882:Paliperidone Palmitate; D012559:Schizophrenia / Q000188:drug therapy; D013607:Tablets
D014150:Antipsychotic Agents; D003692:Delayed-Action Preparations; D007555:Isoxazoles; D013607:Tablets; D000068882:Paliperidone Palmitate