Extrapyramidal adverse events and anticholinergics use after the long-term treatment of patients with schizophrenia with the new long-acting antipsychotic Risperidone ISM®: results from matching-adjusted indirect comparisons versus once-monthly formulations of Paliperidone palmitate and Aripiprazole monohydrate in 52-week studies.

IF 3.6 3区 医学 Q1 PSYCHIATRY Annals of General Psychiatry Pub Date : 2023-09-02 DOI:10.1186/s12991-023-00464-z
Pedro Sánchez, Cecilio Álamo, Marcos Almendros, Max Schlueter, Anastasios Tasoulas, Javier Martínez
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Abstract

Background: Risperidone ISM® is a newly developed long-acting injectable (LAI) treatment for schizophrenia in adults. In the absence of head-to-head comparisons with other similar antipsychotics, the objective of this study was to generate indirect evidence of some aspects of the safety and tolerability of Risperidone ISM compared to other LAI antipsychotics for treatment of patients with schizophrenia in the maintenance treatment setting.

Methods: A literature review was conducted systematically to identify maintenance treatment studies reporting safety and tolerability outcomes for LAI antipsychotic therapies. Following an assessment of between-trial heterogeneity, a matching-adjusted indirect comparison (MAIC) was performed to account for between-trial imbalances in patient characteristics and to generate comparative evidence for safety and tolerability endpoints.

Results: The analysis showed that incidence of extrapyramidal symptoms (EPS) was found to be numerically, but not statistically significantly, lower in patients receiving Risperidone ISM than in those receiving Paliperidone palmitate (PP) (OR [95% CI] 0.63 [0.29, 1.38], p = 0.253) and statistically significantly lower than with Aripiprazole monohydrate once-monthly (AOM) (OR [95% CI] 0.25 [0.12, 0.53], p < 0.001). Use of anticholinergic agents for the alleviation of EPS was also shown to be significantly lower in Risperidone ISM patients than in those receiving PP (OR [95% CI] 0.29 [0.10, 0.83], p = 0.021) or AOM (OR [95% CI] 0.01 [0.003, 0.06], p < 0.001), suggesting a superior tolerability profile for clinically relevant EPS. Results from the sensitivity analyses comparing stabilized and stable patients receiving Risperidone ISM to those receiving AOM yielded similarly favorable conclusions in line with the base case analyses.

Conclusions: This MAIC is consistent with the safety and tolerability results obtained during the PRISMA-3 clinical trial in the long-term treatment of schizophrenia and suggests a favorable safety and tolerability profile in terms of EPS incidence and anticholinergic agent use, relative to other antipsychotic therapies used for treatment of patients with schizophrenia in the maintenance setting.

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精神分裂症患者长期使用新型长效抗精神病药物利培酮ISM治疗后的锥形体外系不良事件和抗胆碱能药物的使用:在52周的研究中,与每月一次的棕榈酸帕利哌酮和阿立哌唑制剂进行匹配调整的间接比较的结果。
背景:利培酮ISM®是一种新开发的成人精神分裂症长效注射(LAI)治疗药物。在没有与其他类似抗精神病药物进行正面比较的情况下,本研究的目的是为利培酮ISM与其他LAI抗精神病药物在维持治疗环境中治疗精神分裂症患者的安全性和耐受性的某些方面提供间接证据。方法:系统地进行文献综述,以确定报告LAI抗精神病药物治疗安全性和耐受性结果的维持治疗研究。在评估试验间异质性后,进行匹配调整间接比较(MAIC),以解释患者特征的试验间不平衡,并产生安全性和耐受性终点的比较证据。结果:分析显示,接受利培酮ISM治疗的患者锥体外系症状(EPS)的发生率在数值上低于接受棕榈酸帕利哌酮(PP)治疗的患者(OR [95% CI] 0.63 [0.29, 1.38], p = 0.253),低于每月一次的阿立哌唑(AOM)治疗的患者(OR [95% CI] 0.25 [0.12, 0.53], p无统计学意义。该MAIC与PRISMA-3临床试验长期治疗精神分裂症的安全性和耐受性结果一致,表明相对于维持环境中用于治疗精神分裂症患者的其他抗精神病药物,在EPS发生率和抗胆碱能药物使用方面具有良好的安全性和耐受性。
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来源期刊
CiteScore
6.60
自引率
2.70%
发文量
43
审稿时长
>12 weeks
期刊介绍: Annals of General Psychiatry considers manuscripts on all aspects of psychiatry, including neuroscience and psychological medicine. Both basic and clinical neuroscience contributions are encouraged. Annals of General Psychiatry emphasizes a biopsychosocial approach to illness and health and strongly supports and follows the principles of evidence-based medicine. As an open access journal, Annals of General Psychiatry facilitates the worldwide distribution of high quality psychiatry and mental health research. The journal considers submissions on a wide range of topics including, but not limited to, psychopharmacology, forensic psychiatry, psychotic disorders, psychiatric genetics, and mood and anxiety disorders.
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