Prevention of episodic migraines with topiramate: results from a non-interventional study in a general practice setting

Abstract

The majority of patients with migraine headaches are treated in non-specialized institutions though data on treatment outcomes are largely derived from tertiary care centers. The current non-interventional study explores efficacy and tolerability outcomes of patients with episodic migraines receiving topiramate as preventive agent in a general practice setting. A total of 366 patients (87% female, mean age 41.8 +/- 11.6 years) were eligible for migraine prevention and treated with flexible dose topiramate for 6 months (core phase), and optionally for a total of 12 months (follow-up phase). Overall, 261 patients (77.7% of safety analysis set, SAF) completed the core phase. Reasons for discontinuation included adverse events (2.1%), lost to follow-up (1.8%), other reasons (1.5%), and end of therapy (0.3%) though in the majority of patients who discontinued no reasons were listed. The median daily dose at endpoint was 50 mg/day (range, 25-187.5 mg/day). The median days with migraine headaches decreased from 6.0 to 1.2 days (p < 0.001), median pain intensity score decreased from 17.0 to 3.2 points (p < 0.001). In women with reported menstruation-associated migraine, the median number of migraine attacks decreased from 4.0 to 0.9 (p < 0.001). Absenteeism as well as triptan use decreased significantly, and significant improvements in activities of daily living and quality of life were reported. The most frequently reported AEs were paraesthesia (4.2%) and nausea (3%). Results suggest that migraine prevention with topiramate in a general practice is generally well tolerated and associated with a significant improvement in migraine headaches and related functional impairment.

Fig. 1

Flowchart showing an overview on the study population

Fig. 2

(a) Number of migraine attacks. (b) Number of days with migraine. Asterisk Number of attacks and days were normalized to a period of 28 days

Fig. 3

Responder rates for the number of migraine attacks and the mean number of days with migraine. Percentages relate to the number of patients with documented visits. Responder rates for days with migraine headache are not described in the text

Fig. 4

Intensity of migraine and other headache in patients with remaining headache. Asterisk Intensity score = (days with severe headache × 3) + (days with moderate headache × 2) + (days with slight headache × 1)

Fig. 5

Impairment of daily life. Asterisk Impairment score = (days with severe impairment × 3) + (days with moderate impairment × 2) + (days with slight impairment × 1)

Fig. 6

Quality of life according to the HIT-6^TM questionnaire