Olanzapine Long-Acting Injection (LAI) Data Presented at First Annual Schizophrenia International Research Society ...(hese events arekey aspects of identifyin...),Health

About HGKB (160-week Interim Results of Open-label Extension Trial)

Adult patients with schizophrenia or schizoaffective disorder (n=931) were enrolled in this ongoing open-label trial of olanzapine LAI following participation in one of three randomized, controlled studies of olanzapine LAI. At study onset, patients received flexibly-dosed olanzapine LAI at intervals of approximately two to four weeks.

At the time of analysis, all patients had had the opportunity to be in the study for at least one year of open-label treatment; some had been enrolled for up to three years of treatment.

Treatment response was measured by the Clinical Global Impression Severity of Illness (CGI-S) scale, which examined severity of illness, global improvement and efficacy. Baseline-to-endpoint mean change on the CGI-S was -0.16, from a baseline of 2.92.

At 160 weeks, the discontinuation rate was low (39.6 percent). The most common reasons for discontinuation were that a patient withdrew consent (20.1 percent), experienced an adverse event (6.3 percent) or was lost to follow up (5.6 percent).

Adverse events reported in 5 percent or more of patients were increased weight, insomnia, somnolence, anxiety, headache, and nasopharyngitis. The mean weight change of study participants was an increase of 1.4 kilograms, with 28.1 percent of patients experiencing an increase of 7 percent or more in weight.

The percentage of patients with a fasting glucose increase from normal to high at any time was 4.7 percent. The percentage of patients with a random total cholesterol increase from normal to high at any time was 5.2 percent. The percentage of patients with a random triglycerides increase fr
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