Cramer Joyce A, Leppik Ilo E, Rue Katrien De, Edrich Pascal, Krämer Günter
Department of Psychiatry, Yale University School of Medicine, 950 Campbell Avenue (G7E, Room 7-127), West Haven, CT 06516-2770, USA.
Epilepsy Res. 2003 Oct;56(2-3):135-45. doi: 10.1016/j.eplepsyres.2003.08.010.
The purpose of this analysis was to compare treatment-emergent adverse events (TEAE) related to use of levetiracetam (LEV) reported by young and elderly patients with anxiety and cognitive disorders, and young epilepsy patients. The LEV database includes reports of TEAE from trials of patients with diagnoses of a cognitive disorder (N=719), an anxiety disorder (N=1510), or localization-related epilepsy (N=1023) who participated in clinical trials lasting up to 16 weeks. Patients were grouped as young (<65 years) or elderly (> or = 65 years). The most common TEAE occurring most frequently in the LEV-treated groups were abdominal pain, asthenia, headache, anorexia, weight loss, dizziness, insomnia, somnolence, and tremor. The only significant differences in TEAE were seen between young and elderly groups with anxiety disorders (>3% higher for LEV than for placebo-treated patients) in headache (5.2% elderly, -0.9% young, P=0.041), and tremor (5.2 and -0.5%, respectively, P=0.022) and between young anxiety patients and young epilepsy patients for somnolence (-0.7 and 5.4%, respectively, P=0.036). For the other TEAEs there was no evidence for consistent differences between young and elderly patients and between patients with different CNS disorders. Overall, LEV was well tolerated by all patient groups. The favorable adverse event profile suggests that LEV might be suitable for use by elderly patients.
本分析的目的是比较年轻和老年焦虑及认知障碍患者以及年轻癫痫患者使用左乙拉西坦（LEV）后出现的治疗中出现的不良事件（TEAE）。LEV数据库包含了参与长达16周临床试验的诊断为认知障碍（N = 719）、焦虑症（N = 1510）或局灶性癫痫（N = 1023）患者的TEAE报告。患者被分为年轻（<65岁）或老年（≥65岁）组。在接受LEV治疗的组中最常出现的TEAE是腹痛、乏力、头痛、厌食、体重减轻、头晕、失眠、嗜睡和震颤。TEAE中唯一显著的差异出现在老年和年轻焦虑症患者组之间（LEV组比安慰剂治疗患者组高>3%），在头痛方面（老年患者为5.2%，年轻患者为 -0.9%，P = 0.041）以及震颤方面（分别为5.2%和 -0.5%，P = 0.022），还有年轻焦虑症患者和年轻癫痫患者在嗜睡方面（分别为 -0.7%和5.4%，P = 0.036）。对于其他TEAE，没有证据表明年轻和老年患者之间以及不同中枢神经系统疾病患者之间存在一致的差异。总体而言，所有患者组对LEV的耐受性良好。良好的不良事件特征表明LEV可能适合老年患者使用。
