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Safety and effectiveness of lurasidone for the treatment of schizophrenia in Asian patients: Results of a 26-week open-label extension study.
Higuchi, Teruhiko; Ishigooka, Jun; Iyo, Masaomi; Hagi, Katsuhiko.
Afiliação
  • Higuchi T; Japan Depression Center, Tokyo, Japan.
  • Ishigooka J; Institute of CNS Pharmacology, Tokyo, Japan.
  • Iyo M; Department of Psychiatry, National University Corporation Chiba University, Graduate School of Medicine, Chiba, Japan.
  • Hagi K; Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
Asia Pac Psychiatry ; 12(1): e12377, 2020 Mar.
Article em En | MEDLINE | ID: mdl-31837113
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 parameters, 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 improvement 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 schizophrenia in Asian patients.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esquizofrenia / Antipsicóticos / Cloridrato de Lurasidona Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esquizofrenia / Antipsicóticos / Cloridrato de Lurasidona Tipo de estudo: Clinical_trials Limite: Adult / Female / Humans / Male / Middle aged País/Região como assunto: Asia Idioma: En Ano de publicação: 2020 Tipo de documento: Article