Luykx J, Mason M, Ferrari M D, Carpay J
Center for Neurobehavioral Genetics, Semel Institute for Neuroscience and Human Behavior, University of California at Los Angeles, Los Angeles, California, USA.
Clin Pharmacol Ther. 2009 Mar;85(3):283-8. doi: 10.1038/clpt.2008.203. Epub 2008 Nov 5.
To compare adverse drug reactions (ADRs) to topiramate in patients with migraine and patients with epilepsy, we systematically reviewed all published randomized controlled trials (RCTs) that compare topiramate monotherapy in epilepsy and migraine. We included four epilepsy RCTs (N = 1,179 patients; vs. active comparators) and six migraine RCTs (N = 1,723 patients; vs. placebo). Behavioral ADRs and headache were found only in the case of epilepsy, whereas cognitive complaints and alteration of taste were found only in the case of migraine. The risk ratios (RRs) for paresthesia in migraine vs. epilepsy trials were 2.5 (99% confidence interval (CI): 1.66-3.77) for 50 mg, 2.7 (99% CI: 1.80-3.97) for 100 mg, and 3.0 (99% CI: 1.95-4.56) for 200 mg. For ADR-related dropouts, the RR was 2.5 (95% CI: 2.03-2.98) for 50 mg but no different for the other doses. We conclude that when treated with the same doses of topiramate, migraineurs show different ADRs than patients with epilepsy and are more likely to drop out because of ADRs.
为比较偏头痛患者和癫痫患者使用托吡酯后的药物不良反应(ADR),我们系统回顾了所有已发表的比较托吡酯单药治疗癫痫和偏头痛的随机对照试验(RCT)。我们纳入了四项癫痫RCT(N = 1179例患者;与活性对照药比较)和六项偏头痛RCT(N = 1723例患者;与安慰剂比较)。行为性ADR和头痛仅在癫痫患者中出现,而认知主诉和味觉改变仅在偏头痛患者中出现。偏头痛试验与癫痫试验中,50 mg托吡酯导致感觉异常的风险比(RR)为2.5(99%置信区间(CI):1.66 - 3.77),100 mg时为2.7(99% CI:1.80 - 3.97),200 mg时为3.0(99% CI:1.95 - 4.56)。对于与ADR相关的退出试验情况,50 mg托吡酯的RR为2.5(95% CI:2.03 - 2.98),但其他剂量时无差异。我们得出结论,使用相同剂量托吡酯治疗时,偏头痛患者与癫痫患者的ADR不同,且偏头痛患者因ADR退出试验的可能性更大。