Safety and effectiveness of rapid-acting intra-muscular olanzapine for agitation associated with schizophrenia – Japan postmarketing surveillance study

Abstract

Objective

The objective of this study was to evaluate the safety and effectiveness of rapid-acting intramuscular (IM) olanzapine in the treatment of acute agitation associated with schizophrenia in real-world clinical settings in Japan.

Methods

In this multicenter, postmarketing surveillance (PMS) study, patients with acute agitation associated with schizophrenia were treated with IM olanzapine daily in a daily clinical setting. The observational period ranged from 1 to 7 days, including the day of initial administration. Safety was assessed by reporting treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The Positive and Negative Syndrome Scale – Excited Component (PANSS-EC) score was used to evaluate effectiveness at baseline and at 2 hours (after each administration), 2 days, and 3 days (end of the observational period) from the last administration of the IM olanzapine injection.

Results

The safety analysis set included 999 patients, and the initial dose of 10 mg was administered to 955 patients. TEAEs were reported in 28 patients (36 events), the most common of which were dyslalia (5 patients), akathisia and somno lence (4 patients each), hepatic function abnormal (3 patients), and constipation and dehydration (2 patients each). One serious adverse event of akathisia occurred during the observation period. The PANSS-EC score (mean ± standard deviation) was 23.3±6.4 (n=625) at baseline, 16.9±7.0 (n=522) at 2 hours after initial injection, and 14.9±6.5 (n=650) at the last observation carried forward.

Conclusion

The results of this Japanese PMS study demonstrated that IM olanzapine is safe and has a favorable effectiveness profile in the treatment of schizophrenia patients with acute agitation.

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Keywords:

• agitation
• Japanese
• postmarketing surveillance study
• rapid-acting intramuscular olanzapine
• schizophrenia
• PANSS-EC

Acknowledgments

The authors would like to thank all patients, physicians, and paramedics who participated in this study. Medical writing assistance was provided by Deborah D’Souza, PhD, inVentiv Health Clinical, LLC, who was funded by Eli Lilly Japan K.K. This study was sponsored by Eli Lilly Japan K.K.

Disclosure

All the authors are employees of Eli Lilly Japan K.K. The authors report no other conflicts of interest in this work.