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.

Migraine Prophylaxis and Acute Treatment Patterns Among Commercially Insured Patients in the United States

“…6 Prior studies that assessed migraine prophylaxis analyzed smaller, older datasets, typically assessing data up to 2005, which is only 1 year after topiramate was granted FDA approval for migraine prophylaxis in the United States, and/or focused on either episodic or chronic migraine. 7,8,10,11 Our study included a larger population and utilized a database to the end of 2012, reflecting a more diverse current patient population, included both episodic and chronic migraine patients, providing more recent trends in prescribing. Therefore, the results are relevant to a broader insured migraine population in the United States.…”

“…1 However, current treatment options for migraine prophylaxis are associated with poor tolerability and low adherence and persistence with treatment. [7][8][9][10][11][12] In clinical practice, adherence has been reported between 27% and 32% after 6 months in patients taking migraine prophylaxis. 7 Moreover, adherence and persistence have also been reported to decline over time.…”

Systematic Review of Migraine Prophylaxis Adherence and Persistence

“…Four open-label studies were identified that evaluated topiramate [21][22][23] or amitriptyline alone, 24 while 2 comparative studies evaluated divalproex and topiramate, 25 and flunarizine and propranolol. 26 Studies were conducted in Germany, [21][22][23] Austria, 24 Belgium, 26 the Netherlands, 27 and Brazil.…”

“…26 Studies were conducted in Germany, [21][22][23] Austria, 24 Belgium, 26 the Netherlands, 27 and Brazil. 25 Dosages varied by individual patient but were within the range of approved FDA-labeled dose for migraine prophylaxis, where applicable.…”

Triptans in prevention of menstrual migraine: a systematic review with meta-analysis

“…Effective preventive strategies are key for the management of MM [9-12]. Rofecoxib [13], estradiol [14,15], topiramate [16,17], magnesium [18], nimesulide [19] and naproxen sodium [20] have been used in the treatment of migraine.…”