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Olanzapine Long-Acting Injection (LAI) Shown to Maintain Treatment Benefit in Schizophrenia for up to Six Months
Date:9/2/2008

eks, 300 mg every two weeks or 405 mg every four weeks), to a low reference dose of olanzapine LAI (45 mg every four weeks), or remained on oral olanzapine at their previously stabilized dose. No supplementation with oral antipsychotics was permitted during the study.

An assessment of clinical stability was based on change in oral olanzapine dose as well as standard measures including Clinical Global Impressions- Improvement of Illness (CGI-I) and Brief Psychiatric Rating Scale (BPRS) scales. Symptom severity was assessed using the Positive and Negative Syndrome (PANSS), PANSS-derived BPRS, and the Clinical Global Impressions-Severity of Illness (CGI-S) and CGI-I scales.

Therapeutic doses of olanzapine LAI were shown to provide positive maintenance of treatment for up to six months. Mean baseline-to-endpoint changes in PANSS total scores for patients treated with therapeutic olanzapine LAI doses (150 mg every 2 weeks, 300 mg every 2 weeks and 405 mg every 4 weeks) differed significantly from those treated with the reference dose (respectively, 2.7, -2.2, -0.1, vs. 7.3; all p<.001). Significant separation in PANSS total scores was seen between the therapeutic doses (150 mg/two weeks, 300 mg/two weeks, 405 mg/four weeks) versus the reference dose (45 mg/four weeks) starting at 11, three, and two weeks, respectively, and maintained throughout the study (p<.05).

Similar differences between therapeutic and reference olanzapine LAI doses were observed for the BPRS total, CGI-I, and CGI-S scores. Mean baseline-to- endpoint change in PANSS total score for the oral olanzapine group (-1.7) did not differ significantly from that of the highest olanzapine LAI dose group (-2.2, 300 mg/2 weeks; p=0.606) but was greater than the other olanzapine LAI doses (p<0.01).

The safety profile for olanzapine LAI was consistent with that of oral olanzapine except for injection-related events. The rate of discontinuation was low over six months of treatment. Incide
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SOURCE Eli Lilly and Company
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