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Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE)

Abstract Background: Schizophrenia affects ∼1.1% of the United States population, resulting in substantial direct, indirect and societal costs. Objective: To evaluate hospitalization rates associated with use of paliperidone palmitate (PP). Methods: Data were from a variable-duration double-blind (D...

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Published in:Current medical research and opinion 2011-08, Vol.27 (8), p.1603-1611
Main Authors: Kozma, Chris M., Slaton, Terra, Dirani, Riad, Fastenau, John, Gopal, Srihari, Hough, David
Format: Article
Language:English
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Summary:Abstract Background: Schizophrenia affects ∼1.1% of the United States population, resulting in substantial direct, indirect and societal costs. Objective: To evaluate hospitalization rates associated with use of paliperidone palmitate (PP). Methods: Data were from a variable-duration double-blind (DB), randomized, relapse-prevention comparison (NCT00111189) of PP vs. placebo (Pbo), followed by a 1-year open-label extension (OLE). Between-phase change in schizophrenia-related hospitalizations was evaluated using data from an investigator-completed questionnaire. Change in hospitalizations using patients before enrollment who participated in the OLE phase was also analyzed. Poisson regression was used to evaluate changes in incidence density within exposure category and by schizophrenia duration. Results: A total of 160 patients in the PP-PP group and 153 in the Pbo-PP group from the DB to the OLE phase were included. Mean age (standard deviation [SD]), gender, and duration of schizophrenia were similar at the start of the DB phase (Pbo: 38.5 years [10.6], 51.0% male, 68.0% 5 years' duration; PP: 37.3 years [11.4] (p = 0.342); 51.9% male (p = 0.874); 70.0% 5 years' duration (p = 0.698), respectively. From the DB to the end of the OLE phase, the number of hospitalizations per person-year for patients treated during the DB phase with Pbo significantly declined from 0.27 to 0.06 (78% reduction; p = 0.005). A statistically nonsignificant difference was observed for PP patients treated during the DB phase with PP (0.11-0.04; 63.6% reduction; p = 0.076), compared with the OLE phase. Change from before enrollment to the end of the OLE phase (n = 381) produced similar results (0.35-0.04; 88.6% reduction; p 
ISSN:0300-7995
1473-4877
DOI:10.1185/03007995.2011.595000