title: Value of postmarketing surveillance studies in achieving a complete picture of antimigraine agents: using almotriptan as an example.
abstract: Randomised controlled trials cannot collect all the data relevant for use in everyday clinical practice because drug exposure is limited, endpoints are restricted and some patient populations are excluded. Postmarketing surveillance (PS) studies can add important information for real-world clinical practice. Acute migraine therapy with almotriptan 12.5 mg was evaluated in 4 PS studies, 2 conducted in Spain, 1 in Germany and 1 in France. Almotriptan was associated with a high rate of treatment response and was well tolerated in all 4 studies. In the Spanish and German studies, 2-hour pain-relief, 2-hour pain-free, and sustained painfree rates were enhanced when patients treated mild pain. Patient satisfaction with almotriptan, assessed in the German and French studies, was high and the majority of patients preferred almotriptan to their previous acute migraine therapy. In conclusion, PS studies augment our knowledge of antimigraine therapy, giving a more complete picture of how such agents work in the general population.
authors.affiliation: Service of Neurology, University Hospital, Salamanca 39008, Spain. juliopascual@telefonica.net
authors.forename: Julio
authors.initials: J
authors.lastname: Pascual
authors.forename: Hans-Christoph
authors.initials: HC
authors.lastname: Diener
authors.forename: Hélène
authors.initials: H
authors.lastname: Massiou
mesh_terms: D006801:Humans; D007391:International Cooperation; D008881:Migraine Disorders / Q000188:drug therapy*; D010147:Pain Measurement; D011358:Product Surveillance, Postmarketing; D016032:Randomized Controlled Trials as Topic; D017366:Serotonin Receptor Agonists / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014363:Tryptamines / Q000627:therapeutic use*
chemical_list: D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C409045:almotriptan