title: 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.
authors.affiliation: Neurology Outpatient Clinic, St. Elisabeth Krankenhaus Köln, 50935 Cologne, Germany. gereon.nelles@uni-duisburg-essen.de
authors.forename: Gereon
authors.initials: G
authors.lastname: Nelles
authors.forename: Lukas
authors.initials: L
authors.lastname: Schmitt
authors.forename: Thomas
authors.initials: T
authors.lastname: Humbert
authors.forename: Veit
authors.initials: V
authors.lastname: Becker
authors.forename: Petra
authors.initials: P
authors.lastname: Sandow
authors.forename: Karin
authors.initials: K
authors.lastname: Bornhoevd
authors.forename: Dirk
authors.initials: D
authors.lastname: Fritzsche
authors.forename: Barbara
authors.initials: B
authors.lastname: Schäuble
mesh_terms: D000041:Absenteeism; D000293:Adolescent; D000328:Adult; D000368:Aged; D000701:Analgesics, Opioid / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004412:Dysmenorrhea / Q000188:drug therapy; D057286:Electronic Health Records; D005194:Family Practice; D005260:Female; D005500:Follow-Up Studies; D005632:Fructose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000145:classification / Q000150:complications / Q000517:prevention & control*; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement / Q000379:methods; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013997:Time Factors; D000077236:Topiramate; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D018696:Neuroprotective Agents; D000077236:Topiramate; D005632:Fructose