ALNIDITAN IN THE ACUTE TREATMENT OF MIGRAINE ATTACKS - A SUBCUTANEOUSDOSE-FINDING STUDY

Alniditan is a new 5HT(1D) receptor agonist, belonging to a different chemical class from sumatriptan and other indole derivatives used or b eing developed for the treatment of acute migraine. In a multinational double-blind randomized parallel-groups dose-finding trial, alniditan was given subcutaneously in hospital to patients with migraine headac he of moderate or severe intensity at doses of 0.8 mg (n=44), 1.0 mg ( n=42), 1.2 mg (n=46) and 1.4 mg (n=39). Efficacy, tolerability and saf ety of each dose were compared with those of placebo (n=41). At 2 h af ter injection, headache was absent or mild in 83% and 82% of patients receiving alniditan 1.2 and 1.4 mg respectively compared with 39% for placebo (p less than or equal to 0.002). Complete relief from headache was achieved in 72% (1.4 mg). Time to onset of relief decreased with increasing alniditan dose, and there was a dose-dependent reduction in headache recurrence rate: 25% of patients receiving 1.4 mg had respon ded by 15 min and headache recurred within 24 h in only 16% of the pat ients who initially responded to alniditan 1.4 mg, significantly less than for placebo (p=0.018). Alniditan was superior to placebo in reduc ing the associated symptoms of nausea, phonophobia and photophobia, an d in increasing patients' functional ability. The use of rescue medica tion was reduced when compared with placebo, and up to 87% of patients said that they would use the drug again if available. No clinically r elevant cardiovascular effects were seen, nor consistent changes in cl inical laboratory findings. Adverse effects, mainly head pressure, par aesthesia, and hot flushes, were reported by 34% of placebo-treated pa tients and up to 70% of patients receiving alniditan, but all doses we re very well tolerated and no clear relationship with dose was establi shed. Comparison with published findings suggests that alniditan 1.4 m g sc may have advantages over sumatriptan 6 mg sc in providing complet e relief from acute migraine headache, and may be associated with fewe r headache recurrences within 24 h. both of these suggestions warrant further and larger trials of alniditan in acute migraine.