Headache Research Unit, Department of Neurology & GIGA-Neurosciences, Liège University, Liège, Belgium.
Cephalalgia. 2010 Nov;30(11):1290-5. doi: 10.1177/0333102409359709. Epub 2010 Mar 10.
Demographic and clinical variables were examined in a post hoc analysis of the PROlonged Migraine Prevention with Topiramate (PROMPT) study to determine potential contribution to relapse.
After a six-month open-label (OL) topiramate phase, patients were randomised to continue topiramate or switch to placebo in a six-month double-blind (DB) phase. 'Relapse' was investigated in terms of change in monthly migraine days after randomisation compared with the month before randomisation, and was analysed during the first ('initial relapse') and last month ('sustained relapse') of the DB phase. More than 40 potential predicting factors were entered into analyses of variance and covariance.
For initial relapse, variable-by-treatment interactions were significant for the Headache Impact Test (HIT-6) at DB baseline, and decline in acute medication intake or reporting of 'anxiety' in the OL phase. For sustained relapse, no statistically significant interactions were observed.
Relapse after topiramate discontinuation in migraine prophylaxis appears to be unaffected by patient characteristics or baseline migraine frequency.
在后 PROlonged Migraine Prevention with Topiramate(PROMPT)研究的事后分析中,检查了人口统计学和临床变量,以确定其对复发的潜在贡献。
在六个月的开放性标签(OL)托吡酯治疗阶段后,患者被随机分配到继续托吡酯治疗或在六个月的双盲(DB)阶段转换为安慰剂。根据与随机前一个月相比,随机化后每月偏头痛天数的变化,研究了“复发”,并在 DB 阶段的第一个(“初始复发”)和最后一个月(“持续复发”)进行了分析。将 40 多个潜在的预测因素纳入方差分析和协方差分析。
对于初始复发,在 DB 基线时头痛影响测试(HIT-6)和 OL 阶段急性药物摄入减少或“焦虑”报告方面,变量与治疗的相互作用具有统计学意义。对于持续复发,未观察到统计学上显著的相互作用。
偏头痛预防中托吡酯停药后的复发似乎不受患者特征或基线偏头痛频率的影响。