Effect of preventive treatment with botulinum toxin type A on acute headache medication usage in migraine patients.

OBJECTIVE: To evaluate the impact of preventive treatment of migraine with botulinum toxin type A (BoNT-A as BOTOX) on the amount of acute headache medications used.

RESEARCH DESIGN AND METHODS: Data from four studies of BoNT-A treatment for migraine were pooled for an aggregate analysis. All studies were at least 12 weeks in duration. For each study, the amounts of headache medications used at weeks 8-12 following BoNT-A treatment were compared with pretreatment baseline amounts and expressed preventive headache care considering acute as a percentage change.

MAIN OUTCOME MEASURES: The mean value for the reduction in medication usage was calculated by pooling data from the individual studies and weighting the data according to the sample size of each study.

RESULTS: Four studies (one published, and three presented as recent meeting abstracts) with a total of 167 patients quantified acute headache medication use before and after BoNT-A treatment. The weighted average reduction in medication usage (primarily triptans) was 57% (range 38-75%).

CONCLUSIONS: The results of this pooled analysis indicated a 57% reduction in acute headache medication use in the 8- to 12-week period following injection of BoNT-A. A reduction of this magnitude could represent substantial savings in the costs of acute medications. This could help to offset the total cost of treatment and suggests BoNT-A may be a cost-reasonable option for medication offsets alone especially in patients with chronic headache with higher acute medication use. Additional larger controlled efficacy and safety studies must be done to confirm these results since three of the four studies were preliminary research and of different study types. Further prospective studies of direct and indirect costs, including those for disability and lost productivity, are needed to evaluate the overall impact of BoNT-A therapy on the economic, societal, and individual burden of migraine headache.