Post-Marketing Cohort Study Comparing the Safety and Efficacy of Flunarizine and Propranolol in the Prophylaxis of Migraine

Abstract

A comparative post-marketing surveillance study of the safety and efficacy of flunarizine and propranolol in the treatment of migraine was carried out. General practitioners in Belgium and the Netherlands each recruited patients for whom they would prescribe one of the study medications in the normal course of their treatment and recorded all medical events on follow-up forms for up to 8 months. A total of 1601 migraine patients were enrolled; 838 in the flunarizine cohort and 763 in the propranolol cohort. Propranolol was somewhat better than flunarizine in reducing the severity of migraine attacks, although this may have been due to a selection bias. Discontinuations of therapy due to events considered likely to be treatment-related were mostly due to the recognized side effects of the two drugs. As regards the occurrence of depressions, a total of 58 patients had depressive events, 34 in the flunarizine cohort and 24 in the propranolol cohort. Whereas migraine itself appears to be associated with an increased risk of depression, the number of previous migraine treatments was shown to be an additional risk factor for the development of depression in patients receiving flunarizine as was a history of depression. Overall, there was no appreciable difference in the risk/benefit ratio between flunarizine and propranolol.

The Paediatric migraine disability assessment score is a useful tool for evaluating prophylactic migraine treatment

“…compared the efficacy of flunarizine and propranolol treatments in children with migraine and reported a similar level of decrease in the frequency of migraine attacks, while propranolol also reduced the severity of attacks. The efficacy of flunarizine and propranolol were assessed in a Belgian study conducted with adults with migraines and this concluded that propranolol was more efficient than flunarizine in reducing the severity of the migraine attacks . Luo et al.…”

Systematic Review of Migraine Prophylaxis Adherence and Persistence

“…26 Studies were conducted in Germany, [21][22][23] Austria, 24 Belgium, 26 the Netherlands, 27 and Brazil. 25 Dosages varied by individual patient but were within the range of approved FDA-labeled dose for migraine prophylaxis, where applicable.…”

Long‐Term Migraine Prevention With Topiramate: Open‐Label Extension of Pivotal Trials

“…Migraine is a chronic disease often requiring long‐term management. Clinical trials assessing the effectiveness of extended drug treatment for migraine prevention (≥1 year) are few in number 6,19,20 . Three large pivotal clinical trials have demonstrated the ability of topiramate 100 and 200 mg/d to significantly reduce mean monthly migraine frequency during a 6‐month period 9‐11 .…”

“…Clinical trials assessing the effectiveness of extended drug treatment for migraine prevention (≥1 year) are few in number. 6,19,20 Three large pivotal clinical trials have demonstrated the ability of topiramate 100 and 200 mg/d to significantly reduce mean monthly migraine frequency during a 6-month period. 9−11 For the open-label extension phase of the 2 North American pivotal trials, 9,10 open-label topiramate was titrated to a clinically effective dose based upon physician judgment of response, which allowed patients to receive topiramate for up to 14 months.…”