Topiramate 100 mg/day in migraine prevention: a pooled analysis of double-blind randomised controlled trials

Abstract

Topiramate has been shown to be effective as a preventive treatment for migraine in three large placebo-controlled, dose-ranging trials. Because the protocols were similar in design using the same primary and secondary endpoints, data from these studies were pooled to evaluate the consistency of efficacy, efficacy by gender and tolerability of topiramate 100 mg/day (n = 386) versus placebo (n = 372). Topiramate was superior to placebo as measured by the reduction in mean monthly migraine frequency, monthly migraine days and monthly migraine duration. The responder rates, defined as at least 50% reduction for the respective parameters, were significantly in favour of topiramate (p < 0.001), for example 46.3% of patients on topiramate achieved at least 50% reduction in monthly migraine period frequency compared with 22.8% on placebo (p < 0.001). Use of medication to treat the acute migraine attack was significantly reduced by topiramate compared with placebo (p < 0.001). The therapeutic effect was consistent throughout the different studies and independent of gender. The most common adverse effect was paraesthesia, mostly of mild-to-moderate severity. The findings confirm that, at a dose of 100 mg/day, topiramate is an effective and well-tolerated drug for migraine prevention.

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

“…78 Divalproex in a larger dose of 1,500 mg/day increased the likelihood of a >50 % improvement in whether migraine attacks impaired usual activities or necessitated symptomatic medication and in reducing migraine attacks with nausea, vomiting, phonophobia, or photophobia. 79 Topiramate 73,74,[80][81][82] and propranolol decreased use of drugs for acute migraine attacks. 83 Among off-label drugs, pooled analyses offered lowstrength evidence that the beta-blocker metoprolol (approved for migraine prevention in Europe) and calcium channel blocker nimodipine were better than placebo in reducing monthly migraine attacks by ≥50 % ( Table 2).…”

CaV2.1 voltage activated calcium channels and synaptic transmission in familial hemiplegic migraine pathogenesis

“…If proven effective, it would be the first migraine prophylactic agent developed on the basis of the CSD hypothesis (Goadsby et al 2009b). Other examples of potential compounds effective as preventive therapy for chronic migraine are Memantine, an activity-dependent N-methylD-aspartate receptor blocker, and Topiramate (Diener et al 2007, Silberstein et al 2007, Bussone et al 2005, Storer and Goadsby 2004, both inhibiting CSD (Goadsby et al 2009b, Akerman andGoadsby 2004). In an attempt to correlate the preventive action of a range of medications with an effect on CSD, Ayata et al (2006) have studied topiramate, valproate, amitriptyline, propranolol and methysergide.…”

Diagnosis, pathophysiology and management of chronic migraine: a proposal of the Belgian Headache Society

“…Adverse effects were mild to moderate in severity and consistent with those noted in previous clinical trials of topiramate: paraesthesia (number-needed-to-harm or NNH 2.4), dysgeusia (NNH 15.3), memory disturbances (NNH 16.6), nausea (NNH 23.1) and fatigue (NNH 31.2) [61]. No serious adverse effects were reported, but it is known from the pooled results of RCT in EM that one patient out of four drops out because of side effects [63].…”