Safety and Effectiveness of Lurasidone in Patients with Schizophrenia: A 12-Week, Open-Label Extension Study.

The goal of this study was to evaluate the safety and effectiveness of lurasidone among patients with schizophrenia in a 12-week open-label extension study. Patients who completed a 6-week, double-blind, placebo-controlled study were enrolled in a 12-week open-label extension study with flexible dosing of lurasidone at 40 or 80 mg/day. Safety assessments included adverse events, vital signs, laboratory tests, and electrocardiogram (ECG) parameters. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), Calgary Depression Scale for Schizophrenia (CDSS) and quality of life measure. A total of 289 patients were enrolled in the open-label extension study. Rates of treatment-emergent adverse events (TEAEs) were low; akathisia was the most common TEAE with an incidence of 6.6%. There were 54 patients (18.7%) who discontinued the extension study, with 17 (5.9%) discontinuing due to adverse events. Minimal or no effects of lurasidone on weight, body mass index, metabolic parameters, prolactin, and ECG parameters were evident. There was continued improvement to week 12 in PANSS and CGI-S scores beyond the initial gains made during the prior 6-week double-blind study. Non-responders to lurasidone 40 mg/day in the prior 6-week study showed a mean (standard deviation) improvement from open-label baseline of 10.7 (13.8) points on the PANSS total score after lurasidone dose was increased to a modal dose of 80 mg/day during the extension study. Changes from double-blind baseline in CDSS and quality of life were maintained in the extension study. Treatment with lurasidone 40 or 80 mg once daily (flexibly dosed) continued to be well tolerated with patients demonstrating further improvement in symptoms over the course of a 12-week open-label extension study in patients with schizophrenia.

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© 2021 Iyo et al.

Déclaration de conflit d'intérêts

Dr Iyo reports personal fees from Otsuka Pharmaceutical Co., Ltd, Jansen Pharmaceutical K.K, Kyowa Pharmaceutical Industry Co., Ltd, and Eli Lilly Japan, and also reports grants and personal fees from Sumitomo Dainippon Pharma and Takeda Pharmaceutical Co., personal fees and other from MSD K.K. Dr Ishigooka reports personal fees from Novartis, Otsuka Pharmaceutical Co., Ltd, Sumitomo Dainippon Pharma, Eli Lilly Japan, Takeda Pharmaceutical Co, Alfresa Pharma, Lundbeck, and Yoshitomiyakuhin. Dr Higuchi reports personal fees from Meiji Seika Pharma, MSD, Allergan, Eisai, Pfizer, Janssen, Lundbeck, Shionogi, Yoshitomi, Kyowa Hakko Kirin, Mochida, Otsuka, Sumitomo Dainippon, Mitsubishi Tanabe, Eli Lilly, and Takeda. M Nakamura, R Sakaguchi, K Okamoto, and K Takai are full-time employees of Sumitomo Dainippon Pharma Co., Ltd. Y Mao and A Fitzgerald are full-time employees of Sunovion Pharmaceuticals Inc. J Tsai was an employee of Sunovion Pharmaceuticals at the time this study was conducted, but is currently at COMPASS Pathways. The authors report no other conflicts of interest in this work.