Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, Haselnusshof 1, Cologne, Germany.
Headache. 2009 Nov-Dec;49(10):1454-65. doi: 10.1111/j.1526-4610.2009.01522.x. Epub 2009 Oct 5.
Headaches are one of the most common neurological symptoms and migraines are the most common primary headache disorder. The global prevalence of migraines is around 10% and the condition is associated with a high burden of disease. Despite an abundance of good quality evidence, only 1 in 5 of patients who fulfill the criteria for preventive migraine therapy are appropriately treated. Data on patient outcomes with preventive medication derive mostly from specialized academic centers, which contrasts with normal clinical practice where the majority of patients are treated outside tertiary care centers.
To explore tolerability, safety and efficacy outcomes of patients receiving topiramate for migraine prevention in a naturalistic setting.
After a 4-week prospective baseline, patients with a diagnosis of migraine according to International Headache Society criteria and eligible for migraine prevention were treated with flexible dosing of topiramate for 24 weeks (core phase), and optionally for a total of 48 weeks. The primary safety analysis included adverse events (AEs) during the core phase. For the main efficacy measures, the absolute changes from baseline to end of core phase as well as last follow-up visit were calculated for migraine days per 4 weeks, migraine attacks per 4 weeks, mean maximum visual analogue scale of migraine headache per 4 weeks and mean maximum pain intensity of migraine headache (4-point scale) per 4 weeks. In addition, changes in individual quality of life aspects were captured.
The intention-to-treat population (ITT) consisted of 161 patients (90.7% female, mean age 45.7 +/- 11.1 years). Topiramate median dose was 45.7 mg/day at endpoint. Some 74.1% of patients reported treatment emergent AEs, most frequently paresthesias (18.4%) and nausea (12.4%). Some 20.0% of patients withdrew from the study due to AEs. The mean number of migraine days per 4 week decreased from 6.2 +/- 3.9 days at baseline to 3.9 +/- 3.5 days at last core visit (P < .001). Mean maximum pain intensity per 4 week changed from 7.0 +/- 2.3 at baseline to 4.7 +/- 3.2 at last visit core phase (P < .001). Consumption of triptans and analgesics reduced during the course of the core phase (P < .005). Fifty-one percent of all patients experienced at least a 50% reduction in migraine days during the core phase.
Topiramate used for migraine prevention in non-academic institutions is generally safe, well tolerated and results in good control of migraine headaches and improvement in several aspects of quality of life.
头痛是最常见的神经学症状之一，偏头痛是最常见的原发性头痛疾病。偏头痛的全球患病率约为 10%，且这种疾病与较高的疾病负担相关。尽管有大量高质量的证据，但只有五分之一符合预防性偏头痛治疗标准的患者得到了适当的治疗。预防性药物治疗的患者结局数据主要来自专门的学术中心，而在常规临床实践中，大多数患者在三级护理中心之外接受治疗。
在自然环境中探究接受托吡酯预防性偏头痛治疗的患者的耐受性、安全性和疗效结局。
在为期 4 周的前瞻性基线期后，根据国际头痛协会标准诊断为偏头痛且符合偏头痛预防治疗标准的患者接受托吡酯的灵活剂量治疗 24 周（核心期），并可选地再治疗 48 周。主要安全性分析包括核心期的不良事件（AE）。对于主要疗效测量指标，从基线到核心期结束以及最后随访的绝对变化，计算偏头痛 4 周发作次数、偏头痛 4 周发作次数、偏头痛 4 周平均视觉模拟评分（VAS）最大值和偏头痛 4 周平均疼痛强度（4 分制）的最大值。此外，还评估了个体生活质量方面的变化。
意向治疗人群（ITT）包括 161 例患者（90.7%为女性，平均年龄 45.7 +/- 11.1 岁）。托吡酯的中位剂量在终点时为 45.7mg/天。约 74.1%的患者报告出现治疗时出现的 AE，最常见的是感觉异常（18.4%）和恶心（12.4%）。约 20.0%的患者因 AE 退出研究。偏头痛 4 周发作次数从基线时的 6.2 +/- 3.9 天减少到最后核心就诊时的 3.9 +/- 3.5 天（P <.001）。偏头痛 4 周平均疼痛强度从基线时的 7.0 +/- 2.3 降至最后核心期就诊时的 4.7 +/- 3.2（P <.001）。核心期内曲坦类药物和镇痛药的消耗减少（P <.005）。核心期内，51%的所有患者偏头痛发作天数减少了至少 50%。
在非学术机构中使用托吡酯预防性偏头痛治疗一般是安全的，耐受性良好，可有效控制偏头痛头痛，并改善生活质量的多个方面。
