Long-Term Efficacy and Safety of Brexpiprazole in Elderly Japanese Patients with Schizophrenia: A Subgroup Analysis of an Open-Label Study
Received 26 June 2020
Accepted for publication 17 September 2020
Published 6 October 2020 Volume 2020:16 Pages 2267—2275
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Taro Kishi
Ken Inada,1 Sakiko Yamada,2 Hisashi Akiyoshi,2 Yoshitsugu Kojima,2 Shuichi Iwashita,3 Jun Ishigooka4
1Department of Psychiatry, Tokyo Women’s Medical University, Tokyo, Japan; 2Department of Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan; 3Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., Osaka, Japan; 4Institute of CNS Pharmacology, Tokyo, Japan
Correspondence: Sakiko Yamada Department of Medical Affairs
Otsuka Pharmaceutical Co, Ltd., Shinagawa Grand Central Tower, 2-6-14 Konan, Minato-Ku, Tokyo 108-8242, Japan
Purpose: This study was performed to assess the long-term efficacy, safety, and tolerability of brexpiprazole in elderly Japanese patients with schizophrenia.
Methods: This is a post hoc analysis of a previous open-label study conducted over 56 weeks which consisted of two consecutive phases: a 4-week switching period and a 52-week open-label period. Mean change in the Positive and Negative Syndrome Scale (PANSS) total score, response rates, number and incidence of treatment-emergent adverse events (TEAEs), and other safety parameters were analyzed using descriptive statistics based on age group (elderly, ≥ 65 and non-elderly, < 65).
Results: This post hoc analysis included 208 de novo patients of which 33 were elderly. The continuation rate in elderly patients was 54.5%, and the mean daily dose and treatment duration of brexpiprazole in elderly patients at week 56 were similar to those of non-elderly patients. The mean change in the PANSS total score from the baseline to week 56 was − 13.8 in elderly patients and this improvement was maintained throughout the open-label phase. This outcome was comparable to that of the non-elderly patients (− 9.0). The incidence rate of TEAEs was 97.0% in elderly patients and 82.3% in non-elderly patients. Most of the TEAEs were either mild (75.8%) or moderate (18.2%) in severity in the elderly patients and the incidence of TEAEs leading to discontinuation was lower in elderly (9.1%) than in non-elderly patients (13.1%). The most commonly observed adverse events in elderly patients were nasopharyngitis (30.3%) and worsening of schizophrenia (27.3%). The safety profiles in both groups were similar.
Conclusion: Brexpiprazole was shown to be safe and effective in the treatment of elderly Japanese patients with schizophrenia.
Keywords: brexpiprazole, long-term, schizophrenia, elderly, safety, Japanese
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