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

J Headache Pain. 2010 Feb;11(1):33-44. doi: 10.1007/s10194-009-0163-x. Epub 2009 Nov 6.

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absenteeism
  • Adolescent
  • Adult
  • Aged
  • Analgesics, Opioid / therapeutic use
  • Drug Administration Schedule
  • Dysmenorrhea / drug therapy
  • Electronic Health Records
  • Family Practice
  • Female
  • Follow-Up Studies
  • Fructose / analogs & derivatives*
  • Fructose / therapeutic use
  • Humans
  • Male
  • Middle Aged
  • Migraine Disorders / classification
  • Migraine Disorders / complications
  • Migraine Disorders / prevention & control*
  • Neuroprotective Agents / therapeutic use*
  • Outcome Assessment, Health Care
  • Pain Measurement / methods
  • Prospective Studies
  • Quality of Life
  • Surveys and Questionnaires
  • Time Factors
  • Topiramate
  • Young Adult

Substances

  • Analgesics, Opioid
  • Neuroprotective Agents
  • Topiramate
  • Fructose