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

Abstract

Schizophrenia is an unexplained, complex and serious mental illness. Blonanserin (BNS) is a new antipsychotic drug widely used in the treatment of schizophrenia. However, large-scale clinical studies have not been conducted in China. A multi-center, prospective, open-label, 12-week surveillance was carried out to evaluate the safety and effectiveness of BNS in patients with schizophrenia in China. Safety assessments included adverse drug reactions (ADRs), extrapyramidal symptoms (EPS), akathisia, concomitant medications for EPS by the end of treatment, and the changes in body weight from baseline by the end of treatment. The effectiveness was evaluated by the Brief Psychiatric Rating Scale (BPRS). From September 2018 to May 2020, of the 1,060 patients enrolled, 1,018 were included in the full analysis set (FAS) and safety set (SS), respectively. ADRs were developed in 205 patients among the included, the incidence being 20.1%. ADRs of EPS occurred in 169 patients, the incidence being 16.6%, ADRs of akathisia occurred in 90 patients, the incidence being 8.8%; concomitant therapeutic and prophylactic agents for EPS accounts for 19.2%; 4.0% of patients had a ≥7% increase in body weight from baseline at 12 weeks after initiating treatment. Using the last-observation-carried-forward (LOCF) method, the changes in total BPRS scores were −11.2 ± 10.17 (N = 1,018), −16.8 ± 12.69 (N = 1,018) and −20.6 ± 13.99 (N = 1,018) after 2/4, 6/8, or 12 weeks, respectively. 53.5% (545/1,018) patients showed response to blonanserin treatment in week 12. The post-marketing surveillance results of BNS demonstrates safety profile and effectiveness of the drug.

Efficacy and safety of blonanserin versus risperidone in the treatment of schizophrenia: a systematic review and meta-analysis of randomized controlled trials

“…In terms of safety, compared with risperidone, the incidence of serum prolactin increases and weight gain is lower in the blonanserin group, but the incidence of EPS is higher. EPS, hyperprolactinemia and weight gain are detrimental to patients’ health and can lead to adverse effects, such as endocrine disorders, disease burden increase, and poor compliance with drugs [ 33 , 34 ]. Thus, we should not only consider the efficacy but also pay attention to the safety to prevent these adverse reactions.…”

“…It is possible that the occurrence of EPS is related to the blood concentration of blonanserin [ 36 ]. The specific mechanism of weight gain caused by antipsychotic drugs is unclear [ 33 ]. This may be associated with decreased activity due to gene and drug-induced sedation and an increase in appetite as a result of receptors such as 5-HT 2C and H 1 [ 37 – 39 ].…”

“…However, one important thing to note is that the incidence of EPS was lower in the risperidone group than in the blonanserin group. Although EPS is mild or moderate and can be eliminated by using antagonists, blonanserin should still be used cautiously [ 33 ]. To ameliorate EPS, the dose can be adjusted by measuring the blood concentration.…”

“…This approach should be further examined in future research. The increase in prolactin caused by antipsychotic drugs may lead to irregular menstruation in women and sexual dysfunction in men, affecting patient compliance [ 33 ]. A study found that blonanserin may be a better choice for young and middle-aged female patients with schizophrenia because it is well tolerated and has a low tendency to cause metabolic side effects and hyperprolactinemia [ 48 ].…”

Safety and effectiveness of oral medium to high dose blonanserin in patients with schizophrenia: subgroup analysis from a prospective, multicenter, post-marketing surveillance study in mainland China

“…Clinical trial data showed that in addition to improving positive and negative SZ symptoms, BNS had a lower risk of weight gain, subthreshold change in glycated hemoglobin (HbA 1c ) [ 8 ], and hyperprolactinemia [ 9 ]. Although the incidence of extrapyramidal symptoms (EPS) was higher than some atypical antipsychotics, the overall safety and tolerance were good [ 10 ].…”