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Lurasidone in the treatment of schizophrenia: Results of a double‐blind, placebo‐controlled trial in Asian patients
Author(s) -
Higuchi Teruhiko,
Ishigooka Jun,
Iyo Masaomi,
Yeh ChinBin,
Ebenezer Esther Gunaseli,
Liang Kuei Yu,
Lee Jung Sik,
Lee Sang Yeol,
Lin Shih Ku,
Yoon BoHyun,
Nakamura Masatoshi,
Hagi Katsuhiko,
Sato Takayuki
Publication year - 2019
Publication title -
asia‐pacific psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.654
H-Index - 21
eISSN - 1758-5872
pISSN - 1758-5864
DOI - 10.1111/appy.12352
Subject(s) - lurasidone , placebo , akathisia , population , positive and negative syndrome scale , medicine , adverse effect , schizophrenia (object oriented programming) , somnolence , anesthesia , gastroenterology , psychiatry , antipsychotic , psychosis , alternative medicine , environmental health , pathology
To evaluate efficacy and safety of lurasidone for the treatment of Asian patients with schizophrenia. Methods Patients with schizophrenia from Japan, South Korea, Malaysia, and Taiwan were randomly assigned to 6 weeks of double‐blind treatment with 40 or 80 mg/d of lurasidone or placebo. The primary efficacy measure was change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total score. Efficacy was evaluated using a mixed‐model repeated‐measures (MMRM) analysis in the modified intention‐to‐treat (mITT) population. Results On the basis of the analysis for the mITT population, the estimated difference score for lurasidone 40 and 80 mg/d vs placebo was −4.8 ( P = 0.050) and −4.2 ( P = 0.080). For the full intention‐to‐treat (ITT) population, the difference score for lurasidone 40 and 80 mg/d vs placebo was −5.8 ( P = 0.017) and −4.2 ( P = 0.043). The most frequent adverse events in the lurasidone 40 and 80 mg/d and placebo groups, respectively, were akathisia (7.3%, 10.4%, 3.3%), somnolence (6.0%, 2.6%, 0.7%), and vomiting (6.0%, 5.8%, 2.0%). The proportion of patients experiencing clinically significant weight gain (≥7%) was 5.3% for lurasidone 40 mg/d, 1.3% for 80 mg/d, and 1.4% for placebo. End point changes in metabolic parameters and prolactin were comparable for both lurasidone groups and placebo. Conclusions In the ITT (but not the mITT) population, treatment with lurasidone was associated with significant improvement in the PANSS total score in patients with schizophrenia. Lurasidone was generally well tolerated with minimal impact on weight and metabolic parameters.