Safety Outcomes from a Long-Term, Prospective Study of Sertraline Use in Children and Adolescents: The Sertraline Pediatric Registry for the Evaluation of Safety.

IF 1.5 4区 医学 Q2 PEDIATRICS
Sara Ramaker, Francesca Kolitsopoulos, Lisa Ludwig, Scott N Compton, Samuel Broderick, John Orazem, Weihang Bao, Yuliya Lokhnygina, Sarah Hackley, Phillip Chappell
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引用次数: 0

Abstract

Objectives: To describe the Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES) safety results, including adverse events (AEs) (serious and nonserious, including suicide-related events) following long-term treatment with sertraline in children and adolescents aged 6-16 years. Methods: SPRITES was a multicenter, prospective, observational study designed to compare cognitive, emotional, and physical development in pediatric patients exposed to sertraline or psychotherapy alone in routine care for up to 3 years. Safety outcomes included AEs collected on the Pediatric Adverse Event Rating Scale and suicidal ideation/behavior (SIB), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS). AEs (unadjusted and adjusted for exposure) and C-SSRS data were summarized descriptively, and a marginal structural model (MSM) was applied to the C-SSRS results. Results: Between April 2012 and September 2020, 941 patients participated in SPRITES. At baseline, per treating physician discretion, 695 patients were administered sertraline, 243 patients were administered psychotherapy alone, and 3 patients were administered an antidepressant other than sertraline. At postbaseline timepoints, patients receiving sertraline reported higher overall rates of AEs relative to the other antidepressants and nonpharmacologic treatment groups. The most common AEs in the sertraline group were related to psychiatric and gastrointestinal disorders. In all exposure groups, the incidence of AEs and SIB decreased across study timepoints. MSM analyses did not demonstrate an effect of sertraline treatment on new onset or worsening SIB. Conclusion: The safety profile of sertraline in a long-term, real-world setting is similar to that of prior pediatric sertraline studies. A greater proportion of AEs and SIB events reported in the sertraline group compared with the nonpharmacologic therapy group is not unexpected given the safety profile of sertraline and observation of baseline differences in psychiatric disease severity between exposure groups. With prolonged sertraline treatment, incidence rates of AEs and SIB events decreased, and worsening of SIB was not observed.

儿童和青少年使用舍曲林的长期前瞻性研究的安全性结果:舍曲林儿科注册安全性评估。
目的:描述6-16岁儿童和青少年长期使用舍曲林治疗后的舍曲林儿科安全性评估(SPRITES)安全性结果,包括不良事件(ae)(严重和非严重,包括自杀相关事件)。方法:SPRITES是一项多中心、前瞻性、观察性研究,旨在比较在常规护理中单独使用舍曲林或心理治疗长达3年的儿科患者的认知、情感和身体发育。安全性结果包括通过哥伦比亚自杀严重程度评定量表(C-SSRS)评估的儿科不良事件评定量表和自杀意念/行为(SIB)收集的不良事件。对ae(未调整和暴露调整)和C-SSRS数据进行描述性总结,并将边际结构模型(MSM)应用于C-SSRS结果。结果:2012年4月至2020年9月,941名患者参与了SPRITES。在基线时,根据治疗医师的判断,695名患者使用舍曲林,243名患者单独使用心理治疗,3名患者使用舍曲林以外的抗抑郁药。在基线后时间点,接受舍曲林治疗的患者报告的不良事件总体发生率高于其他抗抑郁药和非药物治疗组。舍曲林组最常见的不良事件与精神疾病和胃肠道疾病有关。在所有暴露组中,ae和SIB的发生率在整个研究时间点上都有所下降。MSM分析没有证明舍曲林治疗对新发或恶化的SIB有影响。结论:舍曲林在长期现实环境中的安全性与之前的儿童舍曲林研究相似。考虑到舍曲林的安全性和观察到暴露组之间精神疾病严重程度的基线差异,舍曲林组报告的ae和SIB事件的比例高于非药物治疗组并不意外。随着舍曲林治疗时间的延长,ae和SIB事件的发生率降低,且未观察到SIB恶化。
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来源期刊
CiteScore
3.60
自引率
5.30%
发文量
61
审稿时长
>12 weeks
期刊介绍: Journal of Child and Adolescent Psychopharmacology (JCAP) is the premier peer-reviewed journal covering the clinical aspects of treating this patient population with psychotropic medications including side effects and interactions, standard doses, and research on new and existing medications. The Journal includes information on related areas of medical sciences such as advances in developmental pharmacokinetics, developmental neuroscience, metabolism, nutrition, molecular genetics, and more. Journal of Child and Adolescent Psychopharmacology coverage includes: New drugs and treatment strategies including the use of psycho-stimulants, selective serotonin reuptake inhibitors, mood stabilizers, and atypical antipsychotics New developments in the diagnosis and treatment of ADHD, anxiety disorders, schizophrenia, autism spectrum disorders, bipolar disorder, eating disorders, along with other disorders Reports of common and rare Treatment Emergent Adverse Events (TEAEs) including: hyperprolactinemia, galactorrhea, weight gain/loss, metabolic syndrome, dyslipidemia, switching phenomena, sudden death, and the potential increase of suicide. Outcomes research.
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