In the 53-week non-inferiority trial, patients were randomly assigned to receive flexible dose paliperidone palmitate plus orally supplemented placebo (PP+Pbo) or flexible dose risperidone LAT plus orally supplemented risperidone (LAT RIS+RIS). All injections were administered in the gluteal muscle. Patients in the PP+Pbo group received two 50 mg eq. injections one week apart, followed by injections of 25, 50, 75 or 100 mg eq. every 4 weeks. Patients in the LAT RIS+RIS group received a placebo injection on day 1, 25 mg risperidone LAT on days 8 and 22 and injections every 2 weeks of 25, 37.5 or 50 mg. The primary endpoint was the change in PANSS total score from baseline to endpoint. Non-inferiority was planned to be demonstrated if paliperidone palmitate was no worse than risperidone LAT, as measured by a 95% confidence interval of more than -5 points in the change in PANSS total score.
Although patients receiving both paliperidone palmitate and risperidone LAT had similar improvements in PANSS scores at the end of the 53 week trial, the difference between paliperidone palmitate and risperidone LAT in the least square adjusted mean change in PANSS score was -2.6 points, with a 95% confidence interval (CI) of (-5.84, 0.61). As the lower limit (-5.84) of the CI was less than -5, non-inferiority of paliperidone palmitate versus risperidone LAT was not demonstrated using this dosing regimen. Comparative plasma concentrations of paliperidone in the PP+Pbo group were consistently lower than concentrations of active moiety in the LAT RIS+RIS group until day 260. Although non-inferiority was not demonstrated using this dosing regimen, it is not possible to conclude superiority of LAT RIS+RIS over PP+Pbo using the results from this study. Overall rates of adverse events were similar in both groups: 76% for paliperidone palmitate and 79% for risperidone LAT. The most common (>10% in either group) TE
|SOURCE Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.|
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