Blonanserin vs risperidone in Japanese patients with schizophrenia: A post hoc analysis of a phase 3, 8‐week, multicenter, double‐blind, randomized controlled study

Abstract

Objective To report the efficacy and safety of blonanserin in patients with schizophrenia compared with risperidone in a Japanese multicenter, randomized, double‐blind study based on post hoc sensitivity analysis in addition to the previous results reported by Miura and discuss the current approaches for schizophrenia treatment. Methods Of 302 patients randomized, 156 received blonanserin (8‐24 mg/d) and 145 received risperidone (2‐6 mg/d) for 8 weeks. Efficacy variables included the Positive and Negative Syndrome Scale (PANSS) total score for the primary outcome, PANSS subscale, Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression‐Improvement (CGI‐I) for secondary outcomes. Safety variables included treatment‐emergent adverse events, Drug Induced Extrapyramidal Symptoms Scale scores, laboratory data, vital signs, electrocardiogram, etc Results Blonanserin was not inferior to risperidone in the change in PANSS total score at a non‐inferior margin of −7 (intergroup difference, −0.46; 95% CI, −4.40 to 3.48). Post hoc analyses wholly supported the primary result. No major difference was found in the changes in BPRS scores and the improvement rate on CGI‐I between the drugs. The incidence of adverse events was similar in the two drugs. Blonanserin was associated with a lower risk of prolactin increase, weight gain, and orthostatic hypotension compared with risperidone. However, blonanserin was associated with a higher incidence of akathisia and excitability compared with risperidone. Most of the adverse events were mild to moderate in severity with no specific events of predominant high severity in the both drugs. Conclusions Blonanserin exerted the similar efficacy to risperidone in both positive and negative symptoms in schizophrenia with a lower risk of prolactin increase, weight gain, and orthostatic hypotension compared with risperidone. Blonanserin will serve as a favorable treatment option for schizophrenia in daily clinical practice.

Efficacy and Safety of Blonanserin Oral Tablet in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study

“…No deaths and only a few serious/severe AEs were observed. The types and incidence rates of AEs were similar between adolescents in the present study and adults in previous studies on blonanserin (Murasaki 2007 ; Miura 2008 ; Garcia et al 2009 ; Harvey et al 2019 , 2020 ). AEs caused by blonanserin in adolescent patients are considered as predictable as those in adult patients.…”

“…In patients with adult schizophrenia, a randomized controlled study confirmed that blonanserin had greater efficacy than placebo in acute cases (Garcia et al 2009 ). Other randomized controlled studies confirmed the noninferior efficacy of blonanserin to haloperidol (Murasaki 2007 ; Harvey et al 2019 ), showing greater improvement in negative symptoms with fewer extrapyramidal adverse reactions than haloperidol as well as the noninferior efficacy of blonanserin to risperidone (Miura 2008 ; Harvey et al 2020 ), with the following differences in safety profile: compared with risperidone, blonanserin was associated with a lower risk of blood prolactin increase, weight gain, and orthostatic hypotension; however, blonanserin was associated with a higher incidence of akathisia and excitability than risperidone.…”

Long-term oral blonanserin treatment for schizophrenia: a review of Japanese long-term studies

“…The types of adverse events were similar to those in the previous 8-week randomized, controlled studies of blonanserin in Japan [22][23][24][25]. Most of the events occurred within 8 weeks, and there was no increase of adverse events or new emergence of late-onset-type events due to long-term administration.…”

Safety and Effectiveness of Blonanserin in Chinese Patients with Schizophrenia: An Interim Analysis of a 12-Week Open-Label Prospective Multi-Center Post-marketing Surveillance

“…Furthermore, BNS and N-deethyl body has low affinity for adrenaline α1, histamine H1, and muscarinic M1 receptors, which is related to the possible complications during the treatment of the drug. The clinical trials of BNS conducted in Japan, South Korea, and Europe consistently show that its efficacy is comparable with haloperidol and other second-generation antipsychotic drugs such as risperidone (4)(5)(6)(7). The incidence of side effects is lower, such as weight gain and prolactin elevation.…”