| Abstract: | ABSTRACTObjective: To assess differences in the number of days hospitalized among schizophrenic patients receiving paliperidone extended-release (paliperidone ER) during the open-label extension (OLE) phases, compared to a similar time period prior to the screening for entry into the double-blind (DB) trials conducted in the United States.Methods: Mental health-related hospital days during the 52 weeks before entering the DB trials and during the OLE phases were compared. The mean number of hospital days per person per year in the pre- and post-periods was calculated and the statistical significance of pre-post differences was assessed using bootstrap resampling methods. Total person-years were also calculated for the pre- and post-periods to account for different lengths of observation.Results: Patients' (n = 215) mean (?±?SD) age was 41.2 (?±?11.0) years; most were male (73.0?%?); and black (52.1 vs. 45.1?%?white). The mean (?±?SD) paliperidone ER treatment duration during the OLE phase was 167.0 (?±?145.0) days and the mean (?±?SD) daily dose was 10.5 (?±?2.0) mg. Overall, paliperidone ER patients spent an average (?±?SD) of 13.2 (?±?1.6) and 3.1 (?±?0.7) hospital days per person-year in the pre-and post-periods, respectively (mean?±?SD change 10.0?±?1.8, 95?%?CI 6.5, 13.4, p?Conclusions: Patients had significantly fewer hospital days in the OLE phase compared to the 1-year period prior to entering the DB trial. Paliperidone ER may play a role in reducing mental health-related hospital days and associated costs. Important study limitations include the lack of a control group, the pre-post design comparing historical data with data collected in the trials which could create a bias due to the mismatch in settings, and patients having more frequent contact with treating physicians and investigators during the trial period, which could favor the outcomes in the OLE phase. Further studies are needed to confirm these findings. |
