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Analysis of Longer-Term Clinical Study Suggests Psychiatric Hospitalization Rates Decreased in Adults with Schizophrenia Treated With INVEGA® SUSTENNA®
Date:11/19/2010

tes using all patients also was analyzed. A statistical analysis known as Poisson regression was used to evaluate changes in incidence of hospitalization over time and by the duration of each patient's schizophrenia diagnosis.

ResultsThere were 160 patients in the randomized INVEGA SUSTENNA-to-open label INVEGA SUSTENNA group and 153 patients in the randomized placebo-to-open label INVEGA SUSTENNA group.  The average age, gender and duration of schizophrenia diagnosis were similar at the start of the double blind phase for both groups. For the placebo group the average age was 38.5 years, 51 percent of the patients were male and 32 percent had schizophrenia for five or more years. For the INVEGA SUSTENNA group, the average age was 37.3 years, 51.9 percent were male and 30 percent has schizophrenia for five years or more.

During treatment with open-label INVEGA SUSTENNA, the number of hospitalizations per person-year for patients treated during the double-blind phase with placebo significantly declined from 0.27 to 0.06, or a 78 percent reduction (P<0.0047).  For those patients who were treated during the double-blind phase with INVEGA SUSTENNA and continued on INVEGA SUSTENNA during the open label phase, there was a decline in hospitalization rates from 0.11 to 0.04 (a 64 percent reduction, but this was not statistically significant (P<0.0758). Overall, the change in hospitalization rates from prior to initiation of treatment to the open label extension (n=381) produced similar results 0.35-0.04, or 89 percent reduction; P<0.0001.  It must be noted that this was an analysis of an exploratory objective and with that limitations apply to the observed results.  Additional investigations will be needed to confirm these observations and analyses.

This study was supported by Ortho-McNeil Janssen Scientific Affairs, L.L.C.

About Ortho-McNeil Janssen Scientific Affairs, L.L.C.Ortho-McNeil Janssen Scientific Affa
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SOURCE Ortho-McNeil Janssen Scientific Affairs, L.L.C.
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