Frovatriptan in the practice of office-based neurologists/pain therapists: Results of postmarketing surveillance study ALADIN

Abstract

Introduction: Large postmarketing surveillance (PMS) studies have demonstrated the efficacy and tolerability of frovatriptan for treatment of acute migraine in patients attending general practitioners (GPs). The aim of the ALADIN (Allegro Anwendung durch interessierte Neurologen [Allegro application by interested neurologists]) PMS study was to evaluate frovatriptan in patients attending neurologists or pain therapists.

Methods: Patients fulfilling International Headache Society criteria for migraine, with or without aura, were enrolled. Patients completed an attack diary, including details of the attack, time to onset of action of frovatriptan, and recurrence of headache. Physicians completed a case report form detailing prior and actual migraine treatment. Frovatriptan 2.5 mg was administered for up to three consecutive attacks.

Results: In total, 2160 patients were enrolled and data were obtained for 5831 attacks. Patients attending neurologists had more frequent attacks and longer history of migraine compared with those attending GPs. Median time to frovatriptan onset of action was 40 min and time to freedom from headache 70 min. An average of 1.2 frovatriptan tablets was required per attack, and mean additional analgesic use was 0.13. Recurrent headache occurred in 13.6%-15.5% of patients. Physicians as well as patients judged frovatriptan onset and duration of action as at least "good" in approximately 80% of attacks. A similar number judged the efficacy of frovatriptan against headache as "better" than previous treatment. The study drug was generally well tolerated. The frequency of adverse events was 0.6%.

Conclusion: Frovatriptan, with fast onset of action and low rate of headache recurrence, was efficacious and well accepted by migraineurs attending neurologists or pain therapists. Approximately 80% of patients wished to continue migraine treatment with frovatriptan.