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Patients Treated with Risperidone Long-Acting Injection had a Significantly Longer Time to Relapse Compared to Quetiapine in International Clinical Study
Date:5/6/2008

), p<0.0001. Furthermore, over the 24-month treatment period, relapse occurred in 16.5 percent of patients treated with RLAI and 31.3 percent in the quetiapine treatment arm.(6)

Both RLAI and quetiapine had generally comparable safety profiles. Extrapyramidal symptoms (EPS) attributed to medication were observed in 10 percent of the patients receiving RLAI and in six percent of the patients in the quetiapine group. Weight gain was observed in both treatment arms with no statistically significant differences in changes in body weight or BMI versus baseline (seven percent weight gain for RLAI versus 6.2 percent for quetiapine). Potentially prolactin-related adverse events were observed in 16.7 percent of the patients in the RLAI arm and in three percent of patients in the quetiapine arm.

Reasons for withdrawing from the study, other than relapse, were equivalent in both treatment groups except that more withdrawals due to non-compliance/refusing injection were reported for RLAI (three percent) than quetiapine (one percent). The most common serious adverse events were psychiatric symptoms (15 percent with RLAI and 18 percent with quetiapine). Death occurred in three patients treated with RLAI and two with quetiapine. None of the deaths were considered to be possibly or probably related to study drug.

The study was sponsored by Janssen-Cilag, Medical Affairs EMEA.

Separately, an interim analysis from a two-year U.S. observational study also presented today at APA showed patients taking RLAI had significantly improved functioning within three months after starting treatment. That study enrolled 532 patients from 66 community health centers and Veterans Affairs centers in the United States. Data collection occurred at baseline (month 0) and then every three months up to the two years. At the time of this interim analysis, 107 patients had completed the full two-year period.(7)

The U.S. interim analysis showed an overall significant impro
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SOURCE Johnson & Johnson
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