Risk of Suicidal Ideation and Behavior Following Early-Onset Idiopathic Restless Legs Syndrome Treatment.

IF 2.4 4区医学 Q3 PHARMACOLOGY & PHARMACY

Pharmacoepidemiology and Drug Safety Pub Date : 2024-08-01 DOI:10.1002/pds.5852

Brianna Costales, Scott M Vouri, Joshua D Brown, Barry Setlow, Amie J Goodin

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Abstract

Purpose: To estimate incidence rates of suicidal ideation and behavior following treatment initiation with gabapentinoids or dopamine agonists (DAs) in patients with newly diagnosed early-onset idiopathic restless legs syndrome (RLS) and to examine suicidal behavior risk, comparing between those receiving gabapentinoids and DAs.

Methods: A new user retrospective cohort study using MarketScan claims data from 2012 to 2019 was conducted. Exposures were monotherapy gabapentinoids or DAs initiated within 60 days of new RLS diagnosis. Three varying outcome measures of suicidality were examined and incidence rates were calculated for each. A log-binomial regression model the estimated relative risk (RR) of the outcomes with gabapentinoids. Propensity score weighting adjusted for baseline covariates, including age, substance use disorders, hyperlipidemia, antipsychotic use, hypnotic/sedative use, and mood stabilizer use, which were most imbalanced before weighting.

Results: The cohort included 6672 patients, with 4986 (74.7%) initiating a DA and 1686 (25.3%) initiating a gabapentinoid. Incidence rates for all outcome measures were higher in the gabapentinoid group (suicidality: 21.6 vs. 10.7 per 1000 person-years; suicidality with self-harm: 23.0 vs. 11.1 per 1000 person-years; overdose- and suicide-related events: 30.0 vs. 15.5 person-years). Associated risk of suicidality (adjusted RR, 1.27 [95% CI, 0.86-1.88]); suicidality with self-harm (adjusted RR, 1.30 [95% CI, 0.89-1.90]); or overdose- and suicide-related events (adjusted RR, 1.30 [95% CI, 0.93-1.80]) was not significant with gabapentinoids.

Conclusions: Incidence rates for suicidal ideation and behavior were higher among the gabapentinoid group, although increased risk was not detected after adjustment. A possible signal cannot be ruled out given limitations of the data and rarity of the outcome.

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早发特发性不宁腿综合征治疗后出现自杀念头和行为的风险。

目的：估算新诊断的早发性特发性不安腿综合征（RLS）患者开始接受加巴喷丁类药物或多巴胺受体激动剂（DAs）治疗后的自杀意念和行为发生率，并比较接受加巴喷丁类药物和多巴胺受体激动剂治疗的患者的自杀行为风险：利用 2012 年至 2019 年的 MarketScan 索赔数据开展了一项新用户回顾性队列研究。研究对象为新诊断为 RLS 后 60 天内开始接受单药加巴喷丁类药物或 DAs 的患者。研究考察了三种不同的自杀结局指标，并计算了每种指标的发生率。采用对数二项式回归模型估算了加巴喷丁类药物治疗结果的相对风险 (RR)。倾向得分加权调整了基线协变量，包括年龄、药物使用障碍、高脂血症、抗精神病药物使用、催眠药/镇静剂使用和情绪稳定剂使用，这些因素在加权前最不平衡：队列包括6672名患者，其中4986人（74.7%）开始使用DA，1686人（25.3%）开始使用加巴喷丁类药物。所有结果指标的发生率在加巴喷丁类药物组中均较高（自杀：每1000人年21.6例 vs. 10.7例；自杀并自残：每1000人年23.0例 vs. 11.1例；用药过量和自杀相关事件：每1000人年30.0例 vs. 15.5例）：30.0 对 15.5 人/年）。加巴喷丁类药物的相关自杀风险（调整后RR，1.27 [95% CI，0.86-1.88]）、自伤自杀风险（调整后RR，1.30 [95% CI，0.89-1.90]）或用药过量和自杀相关事件风险（调整后RR，1.30 [95% CI，0.93-1.80]）并不显著：结论：加巴喷丁类药物组的自杀意念和行为发生率较高，但调整后并未发现风险增加。鉴于数据的局限性和结果的罕见性，不能排除可能存在信号。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Pharmacoepidemiology and Drug Safety 医学-药学

CiteScore

4.80

自引率

7.70%

发文量

173

审稿时长

3 months

期刊介绍： The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.