A review of the effects of almotriptan and other triptans on clinical trial outcomes that are meaningful to patients with migraine

Background: Traditional end points in clinical trials of migraine therapy, such as 2-hour pain response, may not fully address the outcomes patients consider most important: rapid and sustained freedom from pain over 24 hours, and a low, placebo-like incidence of adverse events. A composite efficacy measure such as the sustained pain-free rate (no pain by 2 hours after dosing, no recurrence, no use of rescue medication from 2 to 24 hours after dosing) may be more appropriate. Objective: Clinically relevant differences between almotriptan and other triptans were reviewed in the context of the attributes of acute migraine treatment that patients consider most important. Methods: This review was based on published reports of open-label and placebo-controlled clinical trials of almotriptan, results of a survey concerning the attributes patients consider most important in a migraine medication, and a published meta-analysis of 53 placebo-controlled clinical trials of triptans involving >24,000 patients. Results: Almotriptan was effective and well tolerated in the placebo-controlled clinical trials-, results of the 6- and 12-month open-label studies supported its good tolerability profile. A respective 87% and 86% of respondents to the patient survey indicated that they considered complete freedom from pain and no recurrence among the most important attributes of migraine treatment, both of which are included in the sustained pain-free rate. In the meta-analysis, almotriptan had a favorable efficacy and tolerability profile compared with other triptans, particularly with respect to sustained pain-free rate, which was significantly higher with almotriptan 12.5 mg compared with sumatriptan 100 mg (25.9% vs 20.0%, respectively-, P < 0.05). In addition, the placebo-subtracted rate of adverse events was significantly lower with almotriptan compared with sumatriptan (1.8% vs 4.4%, respectively-, P < 0.05). Results of a head-to-head placebo-controlled trial of almotriptan 12.5 mg and sumatriptan 100 mg supported the balance of efficacy and tolerability observed for almotriptan in the meta-analysis. Conclusions: Data from clinical trials suggest that almotriptan is effective and well tolerated in the treatment of acute migraine pain. Based on a sustained painfree rate that is among the highest and an adverse-event rate that is among the lowest for the triptans, almotriptan represents a therapeutic option for the initial treatment of acute migraine with or without aura. (Clin Ther 2003;25:331-341) Copyright (C) 2003 Excerpta Medica, Inc.