Fast track — ArticlesCessation versus continuation of 6-month migraine preventive therapy with topiramate (PROMPT): a randomised, double-blind, placebo-controlled trial
Introduction
Migraine is a common neurological disorder, with an estimated yearly prevalence of 4·1–5·7% in men and 13·7–17·3% in women.1 Frequent migraine attacks impair quality of life and ability to carry out daily activities, and decrease productivity as a result of days missed from work or school.2, 3 National and international guidelines for migraine therapy recommend prophylactic treatment in several categories of patient, including those who have frequent or severe attacks, those with uncommon or complicated migraine conditions, and those for whom acute medication is unsuitable or overused.1, 4, 5, 6 Most guidelines recommend that treatment is assessed after 3–12 months, although there is no evidence to support this practice,7 and no controlled trial has investigated what happens when effective prophylactic treatment is discontinued. Theoretically, migraine frequency could return to that reported before treatment began, remain at a frequency reported during treatment, or lie somewhere in-between. A rebound phenomenon, with a steep increase in migraine frequency after the end of treatment, is also possible. We therefore investigated how migraine frequency changes after the end of preventive therapy.
Topiramate is licensed for prophylaxis of migraine, and its efficacy has been shown in several placebo-controlled trials of 6 months' duration.8, 9, 10 In this randomised, placebo-controlled study, the Prolonged Migraine Prevention with Topiramate trial (PROMPT), we compared the effects of discontinuation of topiramate therapy after 6 months with continued treatment for a further 6 months. A secondary aim was to assess the efficacy of topiramate beyond 6 months of use in terms of number of migraine days.
Section snippets
Participants
Patients were enrolled from 88 neurology clinics in 21 countries in Europe and the middle east. Patients were eligible for the trial if they were 18–80 years of age and fulfilled International Headache Society criteria for migraine with or without aura.11 All patients had a history of migraine for at least 1 year, with a mean of at least four migraine days per month during the 3 months before trial entry. All patients needed to be able to keep trial records. Patients were excluded if they had
Results
Participants were recruited between December, 2003, and February, 2005, and the last patient completed the study in May, 2006. Figure 1 shows the trial profile. Of the patients who entered the open-label phase, 68% completed the 26-week period. Two patients (one from each treatment group) did not receive trial medication in the double-blind phase and were excluded from the safety and efficacy analyses. After completion of the open-label phase, 45 eligible patients decided not to proceed to the
Discussion
Our results show that patients who discontinued migraine preventive treatment with topiramate had an increase in the number of migraine days compared with patients who continued treatment. However, topiramate treatment had persistent benefit, because the number of migraine days did not return to pre-treatment values. This has previously been suggested in studies with other migraine preventive treatments such as flunarizine or β blockers,16, 17 although a 12-month placebo-controlled study would
References (20)
- et al.
Migraine prevalence, disease burden, and the need for preventive therapy
Neurology
(2007) - et al.
One-year prevalence of migraine in Sweden: a population-based study in adults
Cephalalgia
(2001) - et al.
Prevalence and burden of migraine in the United States: data from the American Migraine Study II
Headache
(2001) - et al.
French guidelines for the diagnosis and management of migraine in adults and children
Clin Ther
(2004) - et al.
EFNS guideline on the drug treatment of migraine—report of an EFNS task force
Eur J Neurol
(2006) - et al.
Guidelines for all doctors in the diagnosis and management of migraine and tension-type headache
(2004) - et al.
General and pharmacologic approach to migraine management
- et al.
Topiramate for migraine prevention: a randomized controlled trial
JAMA
(2004) - et al.
Topiramate in migraine prophylaxis—results from a placebo-controlled trial with propranolol as an active control
J Neurol
(2004) - et al.
Topiramate in migraine prevention: results of a large controlled trial
Arch Neurol
(2004)
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