Iwata, Nakao and Ishigooka, Jun and Kim, Won-Hyoung and Yoon, Bo-Hyun and Lin, Shih-Ku and Sulaiman, Ahmad Hatim and Cosca, Rowena and Wang, Lina and Suchkov, Yury and Agarkov, Alexey and Watabe, Kei and Matsui, Tomohito and Sato, Takayuki and Inoue, Yoshifumi and Higuchi, Teruhiko and Correll, Christoph U. and Kane, John M. (2020) Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study. Schizophrenia Research, 215. pp. 408-415. ISSN 0920-9964, DOI https://doi.org/10.1016/j.schres.2019.07.055.
Full text not available from this repository.Abstract
Background: Blonanserin is a second-generation antipsychofic used for the treatment of schizophrenia.This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. Methods: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190): of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean LW] difference vs placebo: -5.6 with blonanserin 40 mg; 95% confidence interval CI] -9.6, -1.6; adjusted p = 0.007, and - 10.4 with blonanserin 80 mg; 95% CI -14.4, -6.4; adjusted p < 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. Conclusions: Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability. (C) 2019 The Authors. Published by Elsevier B.V.
| Item Type: | Article |
|---|---|
| Funders: | Sumitomo Dainippon Pharma Co., Ltd. |
| Uncontrolled Keywords: | Dopamine D-3-receptor; Antipsychotics; Adherence |
| Subjects: | R Medicine |
| Divisions: | Faculty of Medicine > Psychological Medicine Department |
| Depositing User: | Ms Zaharah Ramly |
| Date Deposited: | 02 Jun 2023 03:56 |
| Last Modified: | 02 Jun 2023 03:56 |
| URI: | http://eprints.um.edu.my/id/eprint/37045 |
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