Objective: To evaluate the currently published data pertaining to the efficacy and safety of topiramate for prophylaxis of classic and common migraine in pediatric patients.
Data sources: The literature was identified via PubMed (through April 2013) and Iowa Drug Information System (through April 2013). References from identified articles were also reviewed.
Study selection and data extraction: Data were included from studies of efficacy and safety in pediatric patients experiencing migraine (with or without aura), as defined by the International Headache Society. Studies including patients with more specific types of migraine, such as basilar migraine, were excluded.
Data synthesis: Eight publicatons were identified, including 3 randomized controlled trials (RCTs), a subgroup analysis, and 4 observational studies. These studies reported a decrease in headache frequency ranging from 63% to 100% for doses of 100 mg/d and 65% for 200 mg/d. Response to therapy, defined as ≥50% reduction in migraine rate, was also reported in 83% to 95% of patients receiving topiramate. Topiramate is generally well tolerated. Adverse effects were dose related and included paresthesias, weight loss, and cognitive adverse effects.
Conclusion: Topiramate is an effective and well-tolerated prophylactic therapy for use in pediatric migraine patients. Doses of 100 and 200 mg/d (1.47-2.0 mg/kg/d) effectively decrease the frequency of migraine headaches, with 100 mg/d providing optimal benefit-to-risk ratio. Additional randomized, double-blind, placebo-controlled studies are needed to determine the impact of the drug on quality-of-life outcomes, such as school function, and migraine severity and duration.
Keywords: adolescent; migraine; pediatric; prophylaxis; topiramate.