Cicala Giuseppe, de Filippis Renato, Barbieri Maria Antonietta, Cutroneo Paola Maria, De Fazio Pasquale, Schoretsanitis Georgios, Spina Edoardo
Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Psychiatry Unit, Department of Health Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Front Psychiatry. 2023 Apr 6;14:1130636. doi: 10.3389/fpsyt.2023.1130636. eCollection 2023.
Long-acting injectable antipsychotics (LAIs) have proven to be effective in the maintenance treatment of patients suffering from schizophrenia, and their safety and tolerability profiles represent a key factor in their long-term use and choice in clinical practice. Paliperidone palmitate (PP) is the only second-generation LAI (SGA-LAI), available in both one- (PP1M) and 3-month (PP3M) formulations. However, real-world prospective studies on PP1M and PP3M are still few and mostly conducted on small samples. In this context, we aimed to better define the safety and tolerability profile of PP using real world pharmacovigilance data.
We retrospectively analyzed the publicly available data regarding Individual Case Safety Reports (ICSRs), presenting PP1M and/or PP3M as suspected drugs, reported on EUDRAVigilance between 2011 and June 30th, 2022. ICSRs relative to at least one SGA-LAI other than PP, reported between 2003 and June 30th, 2022, were also examined as reference group. Data were evaluated with a descriptive analysis, and then, as disproportionality measures, crude reporting odds ratio (ROR) and 95% confidence interval (CI) were calculated.
A total of 8,152 ICSRs met the inclusion criteria, of those 77.7% ( = 6,332) presented as suspected drug PP1M, 21.2% ( = 1,731) PP3M, while 89 cases indicated both PP1M and PP3M. Significantly higher probabilities of reporting in PP-related reports were observed for the primary Standardized MedDRA Queries "Sexual Dysfunctions" (ROR = 1.45; 95% CI 1.23-1.70), "Haemodynamic oedema, effusions and fluid overload" (ROR = 1.42; 1.18-1.70), as well as "Fertility disorders" (ROR = 2.69; 1.51-4.80).
Our analysis indicates that the tolerability and safety profiles of PP are in line with what is known for the other SGA-LAIs. However, differences regarding endocrine system ADRs have been noticed. The results presented in this work do not discourage the prescription of SGA-LAI formulations but aim to enhance their safety.
长效注射用抗精神病药物（LAIs）已被证明在精神分裂症患者的维持治疗中有效，其安全性和耐受性是其长期使用及临床实践中选择用药的关键因素。棕榈酸帕利哌酮（PP）是唯一可用的第二代长效注射用抗精神病药物（SGA-LAI），有1个月（PP1M）和3个月（PP3M）两种剂型。然而，关于PP1M和PP3M的真实世界前瞻性研究仍然很少，且大多是小样本研究。在此背景下，我们旨在利用真实世界的药物警戒数据更好地界定PP的安全性和耐受性。
我们回顾性分析了2011年至2022年6月30日期间欧洲药物警戒系统（EUDRAVigilance）报告的个体病例安全报告（ICSRs）中，将PP1M和/或PP3M列为可疑药物的数据。还将2003年至2022年6月30日期间报告的至少一种除PP以外的其他SGA-LAI的ICSRs作为参考组进行研究。数据采用描述性分析进行评估，然后计算粗报告比值比（ROR）和95%置信区间（CI）作为不成比例性测量指标。
共有8152份ICSRs符合纳入标准，其中77.7%（n = 6332）将PP1M列为可疑药物，21.2%（n = 1731）将PP3M列为可疑药物，另有89例同时提及PP1M和PP3M。在与PP相关的报告中，主要的标准化MedDRA查询项“性功能障碍”（ROR = 1.45；95% CI 1.23 - 1.70）、“血液动力学水肿、积液和液体超负荷”（ROR = 1.42；1.18 - 1.70）以及“生育障碍”（ROR = 2.69；1.51 - 4.80）的报告概率显著更高。
我们的分析表明，PP的耐受性和安全性与其他SGA-LAIs一致。然而，已注意到在内分泌系统不良反应方面存在差异。本研究结果并非不鼓励使用SGA-LAI剂型，而是旨在提高其安全性。
Zotero 插件