Sánchez Pedro, Álamo Cecilio, Almendros Marcos, Schlueter Max, Tasoulas Anastasios, Martínez Javier
Hospital of Zamudio. Bizkaia Mental Health Network. Osakidetza Basque Health Service, Bilbao, Spain.
Faculty of Health Sciences. Department of Medicine, Deusto University, Bilbao, Spain.
Ann Gen Psychiatry. 2023 Sep 2;22(1):33. doi: 10.1186/s12991-023-00464-z.
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.
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.
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.
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.
利培酮长效注射剂（Risperidone ISM）是一种新开发的用于治疗成人精神分裂症的长效注射剂。在缺乏与其他类似抗精神病药物进行头对头比较的情况下，本研究的目的是生成间接证据，以比较利培酮长效注射剂与其他长效注射抗精神病药物在维持治疗环境中治疗精神分裂症患者时安全性和耐受性某些方面的情况。
系统地进行了文献综述，以确定报告长效注射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之后，进行了匹配调整间接比较（MAIC），以考虑患者特征在试验间的不平衡，并生成安全性和耐受性终点的比较证据。
分析表明，接受利培酮长效注射剂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，但无统计学显著差异（OR [95% CI] 0.63 [0.29, 1.38]，p = 0.253），且在统计学上显著低于接受每月一次阿立哌唑一水合物（AOM）治疗的患者（OR [95% CI] 0.25 [0.12, 0.53]，p < 0.001）。利培酮长效注射剂治疗的患者使用抗胆碱能药物缓解EPS的情况也显著低于接受PP（OR [95% CI] 0.29 [0.10, 0.83]，p = 0.021）或AOM（OR [95% CI] 0.01 [0.003, 0.06]，p < 0.001）治疗者，这表明在临床相关EPS方面具有更好的耐受性。将接受利培酮长效注射剂治疗的病情稳定和稳定的患者与接受AOM治疗的患者进行敏感性分析的结果与基础病例分析得出了类似的有利结论。
这种匹配调整间接比较与PRISMA - 3临床试验在精神分裂症长期治疗中获得的安全性和耐受性结果一致，并且表明相对于用于维持治疗环境中精神分裂症患者的其他抗精神病治疗，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。
