Treatment with brivaracetam has no apparent long-term effects on body weight in pediatric patients with epilepsy

IF 2.8 3区医学 Q2 CLINICAL NEUROLOGY Epilepsia Open Pub Date : 2024-10-02 DOI:10.1002/epi4.13045

Florin I. Floricel, Paula E. Reichel, Najla Dickson, Sofia Fleyshman, Christoph Reichel, Jan-Peer Elshoff

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Abstract

Objective

The objective of this study is to evaluate possible long-term effects of treatment with brivaracetam (BRV) on body weight in children with epilepsy.

Method

Post hoc analysis of data from patients (aged 1 month to <17 years) with ≥6 months of BRV treatment in a long-term, open-label trial (N01266 [NCT01364597]). Outcomes included body weight and body mass index (BMI) over time (z-score growth curves), and treatment-emergent adverse events (TEAEs). Previous/ongoing medical conditions that may affect body weight (gastrointestinal and metabolic/nutritional disorders); concomitant antiseizure medications (ASMs) were also evaluated.

Results

Two hundred nine patients (mean [standard deviation] age 7.9 [4.6] years) were analyzed. Most (154 [73.7%]) had focal-onset seizures. At study initiation, median (range) BRV dose was 1.0 (0.4–7.5) mg/kg/day. Overall, 189 (90.4%) patients had a previous or ongoing medical condition (gastrointestinal disorders: 43 [20.6%]; metabolism/nutritional disorders: 26 [12.4%]). Most patients followed z-score curves for body weight and BMI during BRV treatment, although there were outliers in both directions. Incidences of appetite/weight-change TEAEs were low. Twenty-three (11.0%) patients had a TEAE of decreased appetite and 14 (6.7%) had a TEAE of weight decreased.

Significance

Long-term adjunctive BRV was well tolerated in growing children with no indication of detrimental effects on body weight.

Plain Language Summary

Brivaracetam is an antiseizure medication (ASM) used to treat seizures in people with epilepsy. Some ASMs can lead to changes in people's appetite and weight. Knowing the effect a drug has on appetite and weight is particularly important in children. We looked at 209 children with epilepsy taking brivaracetam and studied changes in their body weight and body mass index over time. The number of reported side effects related to appetite or weight change was low. There was no apparent long-term effect on their body weight, even when taking their medical history and use of other ASMs into account.

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使用溴伐巴坦治疗对小儿癫痫患者的体重没有明显的长期影响。

研究目的本研究的目的是评估布利瓦西坦（BRV）治疗对癫痫患儿体重可能产生的长期影响：方法：对患者（1 个月至 3 岁）的数据进行事后分析：分析了 29 名患者（平均 [标准差] 年龄为 7.9 [4.6] 岁）的数据。大多数患者（154 [73.7%]）有局灶性癫痫发作。研究开始时，BRV 剂量的中位数（范围）为 1.0 (0.4-7.5) mg/kg/天。总体而言，189 名患者（90.4%）曾患有或正在患有某种疾病（胃肠道疾病：43 人 [20.6%]；胰腺疾病：2 人 [20.6%]；心血管疾病：1 人 [20.6%]；糖尿病：1 人 [20.6%]）：43人[20.6%]；代谢/营养失调：26人[12.4%]）。在 BRV 治疗期间，大多数患者的体重和 BMI 都呈 Z 值曲线，但也有两个方向的异常值。食欲/体重变化 TEAE 发生率较低。23例（11.0%）患者出现食欲下降的TEAE，14例（6.7%）患者出现体重下降的TEAE：白话摘要：布利瓦西坦是一种抗癫痫药物（ASM），用于治疗癫痫患者的癫痫发作。某些 ASM 可导致人们的食欲和体重发生变化。了解药物对食欲和体重的影响对儿童尤为重要。我们调查了 209 名服用布利瓦西坦的癫痫患儿，并研究了他们的体重和体重指数随时间的变化。报告的与食欲或体重变化有关的副作用很少。即使考虑到他们的病史和使用其他 ASMs 的情况，对他们的体重也没有明显的长期影响。

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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