Zolmitriptan als Lingualtablette in der Migräne-Anfallsbehandlung – die ZORO Studie

Abstract

In an open, prospective study in 27 Swiss neurological practices and polyclinics, the fastmelt formulation of zolmitriptan was tested in 113 migraine patients as a therapeutic agent for migraine attacks (ZORO [= Zomig oro] Studie). A total of 311 attacks with and without aura were analyzed. With the help of a structured diary, the patients documented each attack in detail by recording the time of onset of the migraine, the intensity, when the medication was taken, the duration of the migraine, concomitant symptoms, concurrent medication and adverse effects. The subjective onset of effect was reached within 60 minutes in 56% of the cases, and within two hours in 73%. The pain intensity was determine with a visual analog pain scale from 1 to 10. The effect, defined by a decline in pain of two or more levels, was achieved within two hours in 68% of the attacks (ITT population). An average of 34% of the ITT patients achieved complete freedom from pain within 120 minutes. The meaningful migraine relief (MMR), defined as a marked improvement in well-being, was achieved within 120 minutes in 59% of all attacks, and after > 2 hours another 34% achieved this state. A decline of approximately 50% in intensity of the concomitant symptoms of nausea, photophobia and phonophobia within two hours was measured on a 10-point visual analog scale (0 = no symptoms; 10 = extremely severe symptoms). After the initial therapeutic effect, migraine recurrences occurred within 4-24 hours after intake of medication in 22% of the cases on the average. The known adverse effects caused by triptan were reported by 17% of the patients. Most of them did not lead to termination of treatment, and none of the more severe adverse effects were reported. In the patient diary, the study participants were also asked about the time of onset of the migraine and the time of taking the medication, in the assumption that this interval would be relatively short from the standpoint of ideal fabrication of the preparation. Surprisingly, despite the fact that patients were instructed by the study neurologists to take the medication as promptly as possible at the onset of an attack, the patients waited a median of 90 minutes after the onset of the migraine (n = 308 attacks) before taking the triptan. In the visual 10-point scale, this time increased the average pain intensity from a median of 5.0 to 6.0. There are various reasons that may explain this unexpected behavior (the experience of many migraine patients that attacks often subside spontaneously within a short period of time; the difficulty of distinguishing an incipient migraine from a tension headache, etc.). Further research will be necessary to clarify this situation. With regard to efficacy in headaches, concomitant autonomic symptoms, rapid onset of effect, and acceptance, this fastmelt triptan formulation represents real competition with the other triptans in the usual tablet formulation. It is especially suitable for active migraine patients who would like to have an effective therapeutic agent available for rapid use in all life situations.