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Olanzapine Long-Acting Injection (LAI) Efficacy and Safety Data Presented at American Psychiatric Association Annual Meeting
Date:5/18/2009

ntipsychotics (N=188) or not receiving any antipsychotics at all (N=34). Of those receiving atypical antipsychotics, 76 were taking oral olanzapine and 16 were on an injectable antipsychotic medication other than olanzapine LAI.

Of 264 total patients, 150 (56.8 percent) were switched directly and the rest were tapered. The two groups did not significantly differ in discontinuation rate (direct: 29.3 percent, taper: 28.9 percent), and there was no significant difference between the groups on PANSS total score mean change at any visit up to eight months (direct: -1.5, taper: -3.4, from a mean baseline of 56.7).

Treatment-emergent adverse events in greater than or equal to five percent of patients were: increased weight (10.2 percent), insomnia (8.3 percent), anxiety (6.8 percent), somnolence (6.8 percent) and increased appetite (5.7 percent). The switch groups did not significantly differ in mean weight change, with an average weight gain of 2.0 kg, nor did they significantly differ in terms of laboratory analytes.

About PDSS

PDSS describes a range of signs and symptoms similar to those observed with oral olanzapine overdose that have been seen in 0.07 percent of olanzapine LAI injections in clinical trials as of February 22, 2009. These signs/symptoms include: sedation (ranging from mild in severity to unconsciousness) and/or delirium (including confusion, disorientation, agitation, anxiety or other cognitive impairment).

Other symptoms can include extrapyramidal symptoms (such as restlessness, muscle stiffness, random movements and tremors), difficulty articulating words (dysarthria), loss of coordination (ataxia), aggression, dizziness, weakness, hypertension and convulsions. As of February 22, 2009, across all clinical trials, PDSS events have been seen in approximately 2 percent of patients, all of whom have recovered. The majority of these patients have chosen to contin
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SOURCE Eli Lilly and Company
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