Migraines with and without aura and their response to preventive therapy with topiramate

Abstract

Data from the Prolonged Migraine Prevention (PROMPT) with Topiramate trial were evaluated post hoc to determine whether topiramate could prevent migraine auras, and whether its efficacy in preventing migraine headaches was similar in patients with (MA; n = 269) and without (MoA; n = 542) aura. Migraines and auras were recorded during prospective baseline, 6-month open-label (OL) topiramate and 6-month double-blind (DB), placebo-controlled phases. In the last 28 OL days, migraines without aura and migraine auras decreased by 43.1% and 54.1%, respectively, in MA patients. MoA patients experienced a 44.3% reduction in migraines. In the DB phase, increases in migraines with placebo vs. topiramate were similar to the full study, but were generally not statistically significant, probably due to lack of power in the subgroup analysis. Similarly, there were no statistically significant changes in number of auras between groups. Thus, topiramate appears to reduce migraine auras in parallel with headache reductions, which are similar in patients with and without aura.

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

“…Several post hoc subgroup analyses of topiramate versus placebo provided inconsistent efficacy evidence regarding aura. 95,96 …”

Perimenstrual migraines and their response to preventive therapy with topiramate

“…These results contradict the perception stated in many published reports (9,11,24,25), and therefore questions the validity of excluding migraines with aura in the proposed ICHD-II definition of MRM. The discrepancy may be explained by the fact that, in the present study at least, only one-third of patients had migraine with aura, in whom only one-third of migraines were actually preceded by an aura (21). The high likelihood (89%) that any new migraine will be one without aura, therefore, might have led others to conclude that the extra migraines observed during the PMP were all migraines without aura.…”

Clinical pharmacology of topiramate in migraine prevention

“…However, the mechanism underlying its action in migraine is unknown [90]. On the basis of its rational of use [49], topiramate should have shown particular efficacy against migraine aura, which has not been demonstrated [50,51]. Its efficacy in migraine prevention is comparable to the other drugs for prophylaxis [91].…”

“…However, a first trial on 12 patients showed that there was no statistically significant decline in the frequency and duration of aura during the 6 months of topiramate treatment compared with baseline values [50]. Even a post hoc analysis of data from the PROMPT study [44] found that there were no statistically significant changes in number of auras between placebo and topiramate groups [51].…”

“…and without aura, perimenstrual, episodic, and chronic [2] for which it would be important to have specific drugs [87]. However, to determine whether topiramate had advantages in one or more of these forms of migraine, post hoc or pooled analysis of the same large group of patients enrolled in the pivotal trials [40,41,46,48,51,73,88] have been almost exclusively conducted. The importance of results from post hoc analysis is limited.…”