Welcome to the Schizophrenia Resource Centre

Welcome, this website is intended for healthcare professionals in EMEA with an interest in the treatment of schizophrenia. By clicking the link below you are declaring and confirming that you are a healthcare professional

You are here

Safety and tolerability of long-acting injectable versus oral antipsychotics: A meta-analysis of randomized controlled studies comparing the same antipsychotics

Schizophrenia Research, Volume 176, Issue 2-3, October 2016, Pages 220 - 230

Abstract

Objective

We aimed to assess whether long-acting injectable antipsychotics (LAIs), which are initiated in a loading strategy or overlapping with oral antipsychotics (OAPs) and which cannot be stopped immediately, are associated with greater safety/tolerability issues than OAPs.

Method

Systematic review and meta-analysis of randomized controlled trials (RCTs) comparing LAIs and OAPs, including only LAI-OAP pairs of the same OAP (allowing oral risperidone and paliperidone as comparators for either risperidone or paliperidone LAI). Primary outcome was treatment discontinuation due to adverse events. Secondary outcomes included serious adverse events, death, ≥ 1 adverse event and individual adverse event rates.

Results

Across 16 RCTs (n = 4902, mean age = 36.4 years, males = 65.8%, schizophrenia = 99.1%) reporting on 119 adverse event outcomes, 55 (46.2%) adverse events were reported by ≥ 2 studies allowing a formal meta-analysis. Out of all 119 reported adverse events, LAIs and OAPs did not differ significantly regarding 115 (96.6%). LAIs were similar to OAPs regarding the frequency of treatment discontinuation due to adverse events, serious adverse events, all-cause death and death for reasons excluding accident or suicide. Compared to OAPs, LAIs were associated with significantly more akinesia, low-density lipoprotein cholesterol change and anxiety. Conversely, LAIs were associated with significantly lower prolactin change.

Conclusion

LAIs and OAPs did not differ on all serious and > 90% of individual adverse events. However, more studies focusing on adverse event frequencies, severity and time course associated with LAI vs OAP formulations of the same antipsychotic are needed. Additionally, adverse events data for LAIs after stopping overlapping oral antipsychotic treatment are needed.

Keywords: Long-acting injectable antipsychotics, Oral antipsychotics, Schizophrenia, Randomized controlled trial, Adverse events, Meta-analysis.

Footnotes

a Yamanashi Prefectural KITA Hospital, Yamanashi, Japan

b The Zucker Hillside Hospital, Psychiatry Research, North Shore - Long Island Jewish Health System, Glen Oaks, NY, USA

c Keio University School of Medicine, Tokyo, Japan

d Hofstra Northwell School of Medicine, Hempstead, NY, USA

e The Feinstein Institute for Medical Research, Manhasset, NY, USA

f Sumitomo Dainippon Pharma Co., Ltd., Medical Affairs, Tokyo, Japan

g Albert Einstein College of Medicine, Bronx, NY, USA

Corresponding author at: The Zucker Hillside Hospital; 75–59 263rd Street, Glen Oaks, NY 11004, USA.