Safety of Long-Acting Injectable Antipsychotics
Author Information
Author(s): Larry Alphs, Srihari Gopal, Keith Karcher, Justine Kent, Jennifer Sliwa, Stuart Kushner, Isaac Nuamah, Jaskaran Singh
Primary Institution: Ortho-McNeil Janssen Scientific Affairs, LLC
Hypothesis
Are the long-acting intramuscular formulations of risperidone or paliperidone palmitate associated with post-injection delirium/sedation syndrome?
Conclusion
The study found no evidence that risperidone LAI and paliperidone palmitate are associated with post-injection delirium/sedation syndrome.
Supporting Evidence
- No cases of PDSS were identified in 15 completed trials of risperidone LAI involving 3,164 subjects.
- Only one case of PDSS was identified in trials of paliperidone palmitate, and it was in a patient receiving placebo.
- The study suggests that findings seen with another antipsychotic LAI are not generalizable to risperidone LAI and paliperidone palmitate.
Takeaway
This study looked at two types of long-lasting injections for mental health and found they don't cause a rare problem called post-injection delirium.
Methodology
The study evaluated clinical trial databases and postmarketing safety databases for reports of post-injection delirium/sedation syndrome.
Limitations
The study may not capture all potential cases of PDSS due to reliance on existing databases.
Participant Demographics
The study included subjects from multiple clinical trials, with a total of 3,164 subjects for risperidone and 3,817 for paliperidone.
Statistical Information
Confidence Interval
Upper 95% confidence limits for PDSS events are 0.003% for risperidone and 0.01% for paliperidone.
Digital Object Identifier (DOI)
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