Part IV: effects of zolmitriptan orally disintegrating tablet on migraine symptoms and ability to perform normal activities: a post-marketing surveillance study in Germany.
Zolmitriptan has been developed in an orally disintegrating tablet (ODT) formulation that rapidly dissolves on the tongue and can be taken quickly, conveniently and discreetly without fluid intake. In this 3-month, non-comparative, observational, post-marketing surveillance (PMS) study, 5,570 physicians prescribed the zolmitriptan 2.5 mg ODT for 16,261 patients with migraine. Of the 14,543 patients who were evaluable for efficacy analysis, 94% had reduced headache intensity within 2 hours of taking zolmitriptan 2.5 mg ODT for the first attack. Improvements were reported within 30 minutes in 35% of patients and within 15 minutes in 7% of patients. Non-headache migraine symptoms and normal daily activities improved for the majority of patients within 2 hours of taking zolmitriptan ODT. Ninety-one percent of patients required only a single dose of zolmitriptan 2.5 mg ODT to treat each attack. Ninety-two percent of patients considered zolmitriptan ODT as having very good or good efficacy and 96% said that tolerability was very good or good. This study also demonstrated that 94% of patients would be willing to continue to use zolmitriptan ODT in the future and 81% of patients considered that being able to take the ODT without water was important or very import ant. In summary, zolmitriptan ODT has demonstrated high efficacy and excellent tolerability. In addition, patients found zolmitriptan ODT to be convenient and easy to use, and were willing to continue using the product. Following placebo-controlled studies, these PMS results provide insight into the use of zolmitriptan ODT in a setting more representative of real life than randomised clinical trials, further demonstrating that it provides a reliable and convenient alternative to conventional tablets.
Diener
Hans-Christoph
HC
Department of Neurology, University Essen, Germany. h.diener@uni-essen.de
Gendolla
Astrid
A
D000203:Activities of Daily Living; D000284:Administration, Oral; D000328:Adult; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000503:physiopathology; D023303:Oxazolidinones / Q000008:administration & dosage / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011788:Quality of Life; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage / Q000627:therapeutic use*
D023303:Oxazolidinones; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C089750:zolmitriptan