ORIGINAL ARTICLE Safety and effectiveness of lurasidone for the treatment of schizophrenia in Asian patients: Results of a 26-week open-label extension study Teruhiko Higuchi MD, PhD 1 | Jun Ishigooka MD, PhD 2 | Masaomi Iyo MD 3 | Katsuhiko Hagi PhD 4 1 Japan Depression Center, Tokyo, Japan 2 Institute of CNS Pharmacology, Tokyo, Japan 3 Department of Psychiatry, National University Corporation Chiba University, Graduate School of Medicine, Chiba, Japan 4 Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan Correspondence Teruhiko Higuchi, Japan Depression Center, Tokyo, Japan; 1-7 K-PLAZA 2F Rokuban-cho, Chiyoda-ku, Tokyo, 102-0085, Japan. Email: higuchi2914@yahoo.co.jp Funding information Sumitomo Dainippon Pharma Abstract Introduction: This study was designed to evaluate the long-term safety and effectiveness of lurasidone in the treatment of schizophrenia among Asian patients. Methods: Patients (N = 281) with schizophrenia who had completed a randomized, double-blind (DB), 6-week comparison of lurasidone (40 and 80 mg/day) and placebo were enrolled in a 26-week extension study in which all patients received open-label (OL), flexible doses of lurasidone (40 or 80 mg/day). Effectiveness was measured using the Positive and Negative Syndrome Scale (PANSS) scale. Results: Fifty-seven percent of patients completed the OL extension study; 16.7% discontinued early due to lack of effectiveness; and 10.3% due to adverse events. The most common adverse events were insomnia (11.3%), akathisia (11.0%), and nasopharyngitis (10.6%). Adverse events related to weight gain, metabolic parame- ters, prolactin, and ECG measures were uncommon. Mean change in the PANSS total score from the DB baseline to OL endpoint was -28.4, with mean improve- ment of -7.5 observed from baseline to OL endpoint, and with a PANSS responder rate of 73.7%. Discussion: The results of the current 26-week extension study found lurasidone to be a generally safe, well-tolerated, and effective long-term treatment for schizophre- nia in Asian patients. KEYWORDS atypical antipsychotic, effectiveness, extension treatment, lurasidone, schizophrenia 1 | INTRODUCTION Results from short- and long-term studies, mostly conducted at sites in the United States and Europe, indicate that lurasidone has signifi- cant efficacy in the treatment of schizophrenia, and is generally safe and well tolerated, with minimal effects on weight, lipid parameters, glycemic indices, and ECG measures (Citrome et al., 2012; Citrome et al., 2014; Loebel et al., 2013; Loebel et al., 2013; Meltzer et al., 2011; Nakamura et al., 2009; Nasrallah et al., 2013; Ogasa, Kimura, Nakamura, & Guarino, 2013; Stahl et al., 2013). Clinically significant differences in hepatic metabolism have been reported for Asian vs Caucasian populations, largely due to polymor- phisms of the cytochrome P450 isoenzyme system (Bertilsson, 2007; Chen, 2006; Johansson et al., 1994). For lurasidone in particular, Asians have been found to have higher area-under-the curve blood concentration levels for a given dose compared to Caucasians (European Medicines Agency, 2017). As lurasidone exhibits a dose- response effect both for efficacy and tolerability (Chapel et al., 2012), it is important to evaluate the efficacy and tolerability of lurasidone in Asian populations. Received: 16 May 2018 Accepted: 15 November 2019 DOI: 10.1111/appy.12377 Asia-Pacific Psychiatry. 2019;e12377. wileyonlinelibrary.com/journal/appy © 2019 John Wiley & Sons Australia, Ltd 1 of 4 https://doi.org/10.1111/appy.12377