Efficacy, Tolerability, and Safety of Blonanserin in Schizophrenia: An Updated and Extended Systematic Review and Meta-Analysis of Randomized Controlled Trials

Kishi, Taro; Matsui, Yoshihiko; Matsuda, Yuki; Katsuki, Asuka; Hori, Hikaru; Yanagimoto, Hiroko; Sanada, Kenji; Morita, Kenichi; Yoshimura, Reiji; Yamanaka, Shōji; Hagi, Katsuhiko; Iwata, Nakao

doi:10.1055/a-0574-0088

Cited by 26 publications

(35 citation statements)

References 19 publications

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“…The daily dose administered to FAS population was 8-24 mg (mean, 15.7 mg at end of study) for blonanserin, which is the same as those instructed in the current local package insert; and 4-12 mg (mean, 7.9 mg at end of study) for haloperidol, being in agreement with its recommended optimal dose. 15,16 Very few of the enrolled patients were treatment-naïve or in the In the present FAS analysis, consistent results were obtained which confirm the previous findings based on PPS, 9 demonstrating that blonanserin was not inferior to haloperidol with respect to the improvement rate on CGI-I after 8 weeks of treatment. The result was, in both PPS and FAS, supported by the other efficacy endpoint data; decrease in the PANSS total score from baseline did not differ between the drugs.…”

Section: Discussionsupporting

confidence: 90%

“…The efficacy of blonanserin for schizophrenia is comparable with that of other SGAs, as shown in a meta‐analysis of randomized controlled trials comparing blonanserin with other antipsychotics . Of the SGAs other than blonanserin, however, only aripiprazole and olanzapine have data showing a significantly higher efficacy than haloperidol against negative symptoms in Japanese patients …”

Section: Discussionmentioning

confidence: 93%

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Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8‐week, double‐blind, multicenter, randomized controlled study

Harvey

Nakamura

Murasaki³

2019

Neuropsychopharm Rep

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Objective This Japanese, multicenter, randomized, double‐blind trial, evaluating the efficacy and safety of blonanserin compared with haloperidol in patients with schizophrenia, was previously published by Murasaki in the Japanese language. In this article, we present the results of the trial based on full analysis dataset instead of per protocol dataset formerly reported and discuss the findings in light of the latest knowledge of pharmacological treatment for schizophrenia. Methods A total of 265 patients were randomized to receive blonanserin (8 to 24 mg/d) or haloperidol (4 to 12 mg/d) twice daily for 8 weeks. Efficacy assessments included the Clinical Global Impressions—Improvement (CGI‐I) and the Positive and Negative Syndrome Scale (PANSS). Results Blonanserin was not inferior to haloperidol with a margin of 10% with respect to the improvement rate on CGI‐I at end of study (60.5% vs 50.0%, P < 0.001). The decrease in the PANSS total score did not differ between the drugs (−10.3 vs −7.1). For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006). Blonanserin was well tolerated. The incidence of adverse events was similar for the two drugs. Extrapyramidal adverse events, sedation, hypotension, and prolactin increase were rarer with blonanserin than with haloperidol. No clinically important weight gain was observed. Conclusions Blonanserin is as effective as haloperidol for the treatment of schizophrenia. Blonanserin is more effective for negative symptoms with a lower risk of extrapyramidal symptoms compared with haloperidol.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 93%

Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8‐week, double‐blind, multicenter, randomized controlled study

Harvey

Nakamura

Murasaki³

2019

Neuropsychopharm Rep

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“…Akathisia associated with blonanserin does not seem to pose an unacceptable risk as long as a patient is carefully observed primarily at the early stage of treatment or after dose increase with blonanserin, which would also be the case for other SGAs. In the updated meta‐analysis of 10 randomized controlled trials including this study, the overall safety outcome did not differ between blonanserin and other antipsychotics including risperidone or aripiprazole while some variation in each adverse event, such as akathisia, extrapyramidal symptoms, prolactin levels, or weight gain …”

Section: Discussionmentioning

confidence: 76%

“…In the updated meta-analysis of 10 randomized controlled trials including this study, the overall safety outcome did not differ between blonanserin and other antipsychotics including risperidone or aripiprazole while some variation in each adverse event, such as akathisia, extrapyramidal symptoms, prolactin levels, or weight gain. 23 Blonanserin has a functional selectivity with high affinity for the dopamine D 2 , D 3, and the serotonin 5-HT 2A receptors over other receptors. 24 Its higher affinity for D 2 receptors than for 5-HT 2A receptors improves various psychiatric symptoms in schizophrenia along with the fewer side effects such as extrapyramidal.…”

Section: Discussionmentioning

confidence: 99%

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

Harvey

Nakamura

Miura

2019

Neuropsychopharm Rep

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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.

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“…In short-and long-term studies, blonanserin was effective and well tolerated in patients with schizophrenia [2,[4][5][6][7][8][9]. In a meta-analysis of randomized controlled clinical trials, blonanserin was more effective than aripiprazole in improving total Positive and Negative Syndrome Scale (PANSS) scores, and was associated with a lower risk of hyperprolactinemia, but a higher risk of akathisia, agitation/excitement, and extrapyramidal symptoms (EPS), compared with a combination of risperidone and paliperidone [10].…”

Section: Introductionmentioning

confidence: 99%

Long-Term Safety and Efficacy of Blonanserin Transdermal Patches in Japanese Patients with Schizophrenia: A 52-Week Open-Label, Multicenter Study

Iwata

Ishigooka²,

Naoi

et al. 2019

CNS Drugs

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Background Blonanserin transdermal patch therapy is now available in Japan for the treatment of schizophrenia and may provide several advantages over the tablet formulation. Objective The aim was to evaluate the long-term safety and efficacy of blonanserin transdermal patches in Japanese patients with schizophrenia. Methods An open-label study was conducted in adults with schizophrenia at 37 sites in Japan. Patients were enrolled in either cohort 1 or 2. Patients in cohort 1 received 8-16 mg/day blonanserin tablets for 6 weeks and then 40-80 mg/day blonanserin patches for 52 weeks. The dose of blonanserin patches was determined according to the dose of the tablets. In cohort 2, every patient started from 40 mg/day and then 40-80 mg/day blonanserin transdermal patches for 52 weeks. Both cohorts had 1-2 weeks of follow-up. Safety endpoints included the incidence of adverse events (AEs), treatment-related AEs, extrapyramidal AEs [also assessed using the change in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) score], the use of any concomitant antiparkinsonian drugs, and skin-related AEs, including skin irritation. Patients also underwent assessment of laboratory values including for serum prolactin concentration, vital signs, body weight, electrocardiographic (ECG) changes, and the corrected QT (QTc) interval. Suicidal ideation was assessed via the Columbia-Suicide Severity Rating Scale (C-SSRS) score. Efficacy was assessed via duration of blonanserin transdermal patch treatment, Positive and Negative Syndrome Scale (PANSS) total and subscale scores, and Clinical Global Impression-Severity (CGI-S) scores. Other endpoints included total Drug Attitude Inventory 10 (DAI-10) scores, EuroQol-5 Dimension (EQ-5D) effect values, and a patient questionnaire about the dosage form. Results A total of 223 patients with consents, 117 in cohort 1 and 106 in cohort 2 were included in the study. Of the 117 patients in cohort 1, 108 were treated with blonanserin tablets, and 97 received blonanserin patches and were included in the safety analysis set. In cohort 2, 103 of the 106 patients were treated with blonanserin transdermal patches and were included in the safety analysis set. In total, 91 patients were male (45.5%). The mean age was 43.8 years. Discontinuation occurred in 40 patients (41.2%) in cohort 1 and 44 patients (42.7%) in cohort 2. Discontinuation resulted from AEs in 18.6% (cohort 1) and 11.7% (cohort 2) and from withdrawal of consent in 13.4% (cohort 1) and 20.4% (cohort 2), and seven patients overall discontinued due to skin reactions. AEs were reported in 174 patients (87.0%), and 13 serious AEs occurred in 12 patients (6.0%), of which six patients were in cohort 1 and six patients were in cohort 2. Serious AEs were six schizophrenia (n = 6) and seven other AEs (n = 6), which included impulse-control disorder, fracture, epistaxis, asthma, pneumonia aspiration, pneumonia hemophilus, and pneumonia. The most common AEs were nasopharyngitis (n = 62, 31.0%), application site erythema (n = 45, 22.5%), application s...

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Efficacy, Tolerability, and Safety of Blonanserin in Schizophrenia: An Updated and Extended Systematic Review and Meta-Analysis of Randomized Controlled Trials

Abstract: The current meta-analytic study did not update the comparison of blonanserin vs. haloperidol because there were no new RCTs. Our results suggest that the efficacy of blonanserin for schizophrenia is comparable with that of other antipsychotics, and blonanserin seems to be well tolerated.

Cited by 26 publications

References 19 publications

Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8‐week, double‐blind, multicenter, randomized controlled study

Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8‐week, double‐blind, multicenter, randomized controlled study

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

Long-Term Safety and Efficacy of Blonanserin Transdermal Patches in Japanese Patients with Schizophrenia: A 52-Week Open-Label, Multicenter Study

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