Topiramate in migraine prophylaxis

Abstract

Topiramate (TPM) has shown efficacy in migraine prophylaxis in two large placebo-controlled, dose-ranging trials. We conducted a randomised, double-blind, multicentre trial to evaluate the efficacy and safety of two doses of topiramate vs placebo for migraine prophylaxis, with propranolol (PROP) as an active control. Subjects with episodic migraine with and without aura were randomised to TPM 100 mg/d, TPM 200 mg/d, PROP 160 mg/d (active control), or placebo. The primary efficacy measure was the change in mean monthly migraine frequency from the baseline phase relative to the double-blind treatment phase. Five hundred and seventy-five subjects were enrolled from 61 centres in 13 countries. TPM 100 mg/d was superior to placebo as measured by reduction in monthly migraine frequency, overall 50% responder rate, reduction in monthly migraine days, and reduction in the rate of daily rescue medication use. The TPM 100 mg/d and PROP groups were similar with respect to reductions in migraine frequency, responder rate, migraine days, and daily rescue medication usage. TPM 100 mg/d was better tolerated than TPM 200 mg/d, and was generally comparable to PROP. No unusual or unexpected safety risks emerged. These findings demonstrate that TPM 100 mg/d is effective in migraine prophylaxis. TPM 100 mg/d and PROP 160 mg/d exhibited similar efficacy profiles.

Prophylaxis of migraine headache

“…Our meta-analysis of four trials comparing topiramate 100 mg to placebo 11,[22][23][24][25] in 828 patients showed an odds ratio of 2.44 (95% CI 1.81-3.28, p < 0.0001) for a 50% or greater reduction in migraine frequency relative to placebo. Although topiramate is very effective, adverse effects cause cessation of therapy in up to 30% of patients on the 200-mg dosage in randomized trials.…”

“…Topiramate may be useful for prevention of migraine in patients who are overweight because it does not cause weight gain and may help in weight loss. In head-tohead trials, topiramate appeared to have similar efficacy to propranolol 22 and divalproex sodium. 21 Patients with comorbid epilepsy or bipolar disorder may be offered an antiepileptic for migraine prophylaxis to simplify medication regimens, although no evidence exists to support this recommendation.…”

Cost-Minimization Analysis Comparing Topiramate with Standard Treatments in Migraine Prophylaxis

“…A wide range of head-to-head comparisons therefore appears to confirm the clinical noninferiority of flunarizine in comparison with propranolol and therefore is listed as a first-line prophylactic treatment option in the European Federation of Neurological Societies (EFNS) guideline [12]. Since these three treatment options comparing several doses have equal effectiveness, we continued with a cost-minimization analysis using the findings by Diener et al [10]. According to these results, we assumed that flunarizine would be as effective as propranolol if incorporated as an indirect comparator group into the study [10].…”

“…Since these three treatment options comparing several doses have equal effectiveness, we continued with a cost-minimization analysis using the findings by Diener et al [10]. According to these results, we assumed that flunarizine would be as effective as propranolol if incorporated as an indirect comparator group into the study [10]. …”

“…There is no single clinical trial simultaneously comparing topiramate, propranolol and flunarizine treatments in migraine prophylaxis. Therefore, we included studies that have separately compared the effectiveness of topiramate either with propranolol or with flunarizine and the comparative studies that found equal effectiveness and safety of flunarizine with propranolol [10,11,12]. A wide range of head-to-head comparisons therefore appears to confirm the clinical noninferiority of flunarizine in comparison with propranolol and therefore is listed as a first-line prophylactic treatment option in the European Federation of Neurological Societies (EFNS) guideline [12].…”