Efficacy and tolerability of blonanserin in the patients with schizophrenia: A randomized, double-blind, risperidone-compared trial

Jaewon Yang, Won Myong Bahk, Hyun Sang Cho, Yang Whan Jeon, Duk In Jon, Hee Yeon Jung, Chan Hyung Kim, Hee Cheol Kim, Yong Ku Kim, Young Hoon Kim, Jun Soo Kwon, Sang Yeol Lee, Seung Hwan Lee, Jung Seo Yi, Bo Hyun Yoon, Seung Hyun Kim

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    57 Citations (Scopus)

    Abstract

    Objectives: The objective of this study was to evaluate the efficacy and tolerability of blonanserin for the treatment of Korean patients with schizophrenia using a double-blind risperidone-compared design. Methods: Patients aged 18 to 65 years with schizophrenia were randomly assigned to blonanserin or risperidone treatment for 8 weeks. The efficacy was assessed using the mean change in Positive and Negative Syndrome Scale score total scores from baseline to week 8. Safety assessments included monitoring of vital signs, a physical examination, laboratory tests, and adverse events. Results: Of 206 randomly enrolled patients, 103 receiving blonanserin and 103 receiving risperidone were included in the analysis. In this study, noninferiority between blonanserin and risperidone was demonstrated. The mean change in the Positive and Negative Syndrome Scale total score at the final evaluation time point was-23.48 ± 19.73 for the blonanserin group and-25.40 ± 18.38 for the risperidone group. Adverse events, which occurred less frequently in the blonanserin than in the risperidone group, included dysarthria (P = 0.0288), dizziness (P = 0.0139), increased alanine aminotransferase and aspartate aminotransferase (P = 0.0095 and P = 0.0032, respectively), and increased level blood prolactin (P = 0.0012). On the other hand, the adverse events that occurred more frequently in the blonanserin than in the risperidone group was hand tremor (P = 0.0006). Conclusions: Blonanserin was effective in the treatment of Korean patients with schizophrenia compared with risperidone and was more tolerable with a better safety profile, particularly with respect to prolactin elevation. These findings suggest that blonanserin is useful in the treatment of schizophrenia.

    Original languageEnglish
    Pages (from-to)169-175
    Number of pages7
    JournalClinical Neuropharmacology
    Volume33
    Issue number4
    DOIs
    Publication statusPublished - 2010 Jul

    Keywords

    • blonanserin
    • efficacy
    • schizophrenia
    • tolerability

    ASJC Scopus subject areas

    • Pharmacology
    • Clinical Neurology
    • Pharmacology (medical)

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