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Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia

  • Henry A. Nasrallah (a1), Ralph Aquila (a2), Yangchun Du (a3), Arielle D. Stanford (a3), Amy Claxton (a3) and Peter J. Weiden (a3)...

Abstract

Objective

Safety and tolerability of long-term treatment with the long-acting antipsychotic aripiprazole lauroxil (AL) were evaluated in patients with schizophrenia.

Methods

This was an international, multicenter, phase 3, 52-week safety study of 2 fixed doses of AL (441 mg or 882 mg intramuscular every 4 weeks). Safety endpoints included adverse events (AEs) and extrapyramidal symptoms (EPS) including akathisia, injection-site reactions (ISRs), and clinically relevant changes in metabolic and endocrine values.

Results

Of 478 patients entering this study, 236 (49%) continued from a previous 12-week, phase 3 efficacy study of AL, and 242 (51%) were newly enrolled. Overall, 77% and 23% of patients received AL 882 mg (N = 368) and 441 mg (N = 110), respectively. AEs occurred in 50.4% of patients; most were mild (28.7%) or moderate (18.2%). The most common AEs were insomnia (8.4%) and increased weight (5.0%). Akathisia was reported as an AE in 3.8% of the overall population, with higher rates in patients initiating AL on study entry than those continuing on AL. EPS-related AEs occurred in 9.4% of patients, and AEs related to metabolic parameters were reported in 4.6% of patients. Weight gain was minimal (0.8 kg), and no clinically relevant changes were observed for metabolic parameters. The overall incidence of ISRs was 3.8%; most were associated with the initial injections in patients receiving their first injection in this study.

Conclusion

Long-term treatment with AL is generally well tolerated, with a safety profile consistent with that of oral aripiprazole. It is a suitable option for patients with schizophrenia.

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Copyright

This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.

Corresponding author

*Address for correspondence: Henry A. Nasrallah, MD, Department of Psychiatry and Behavioral Neuroscience, Saint Louis School of Medicine, 1438 S. Grand Boulevard, St. Louis, MO 63104, USA. (Email: hnasral@slu.edu)

Footnotes

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ClinicalTrials.govidentifier: NCT01626456; EudraCT Number: 2012-003996-20.

This study was sponsored by Alkermes, Inc., Waltham, MA, USA. Funding for editorial support was provided by Alkermes, Inc., Waltham, MA, USA.

Study results have been presented as a poster at the American Psychiatric Association Annual Meeting, May 20–24, 2017, San Diego, CA, USA, and the American Society of Clinical Psychopharmacology Annual Meeting, May 29–June 2, 2017, Miami, FL, USA.

The authors thank all the patients and investigators who participated in and contributed to this study. The authors thank Drs. Robert Risinger and Chih-Chin Liu (both formerly of Alkermes, Inc.) for their contributions to the analyses of the study. Medical writing and editorial support for the preparation of this manuscript (under the guidance of the authors) was provided by Karen Yee, PhD (ApotheCom, UK).

Footnotes

References

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Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia

  • Henry A. Nasrallah (a1), Ralph Aquila (a2), Yangchun Du (a3), Arielle D. Stanford (a3), Amy Claxton (a3) and Peter J. Weiden (a3)...

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