Dose-associated changes in safety and efficacy parameters observed in a 24-week maintenance trial of olanzapine long-acting injection in patients with schizophrenia
2011

Study on Olanzapine Long-Acting Injection for Schizophrenia

Sample size: 599 publication 10 minutes Evidence: moderate

Author Information

Author(s): Angela L. Hill, Bin Sun, Jamie L. Karagianis, Susan B. Watson, David P. McDonnell

Primary Institution: Lilly Research Laboratories, Eli Lilly and Company

Hypothesis

Significant dose-associated changes would be identified for both safety and efficacy parameters in this olanzapine LAI clinical trial.

Conclusion

Higher doses of olanzapine LAI may lead to better efficacy outcomes but also greater adverse changes in metabolic safety measures.

Supporting Evidence

  • Higher doses of olanzapine LAI were associated with a lower relapse rate.
  • Patients on the high dose had a longer time to relapse compared to those on the low dose.
  • Weight gain increased with higher doses of olanzapine LAI.

Takeaway

This study looked at how different doses of a medication for schizophrenia affect patients' health and safety. Higher doses helped more with symptoms but also caused more weight gain.

Methodology

Patients with schizophrenia were randomly assigned to low, medium, or high doses of olanzapine LAI for 24 weeks, and various safety and efficacy measures were analyzed.

Potential Biases

Potential for false positives due to not correcting for multiple comparisons.

Limitations

The analyses were post hoc and exploratory, and certain adverse events during the lead-in phase were not represented.

Participant Demographics

Patients aged 18 to 75 with a diagnosis of schizophrenia.

Statistical Information

P-Value

p <.01

Confidence Interval

95% CI: 4 to 43

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-244X-11-28

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