Efficacy of almotriptan in early intervention for treatment of acute migraine in a primary care setting: the START study

Abstract

Aims: The benefits of taking almotriptan early for acute migraine when pain is mild have clearly been demonstrated in the neurology setting. The aim of this study was to determine whether similar benefits with early intervention of almotriptan can be achieved in everyday general practice, where most migraineurs are managed.

Methods: In this European, prospective, observational study, patients were asked to treat up to three migraine attacks over a 2-month period with almotriptan 12.5 mg administered within 1 h of pain onset and when pain was mild (early + mild intervention group).

Results: A total of 501 patients were enrolled in primary care centres across Spain, France and Italy. The intention-to-treat analysis involved 454 patients who reported 1174 migraine attacks, with early intervention being used in 138 of these attacks. A greater proportion of patients who took almotriptan early + mild for their first migraine attack (n = 42) were pain free at 2 h compared with those in the non-early + mild intervention group (n = 410) (62% vs. 35%; p < 0.001). Similar results were obtained for all migraine attacks comparison [65% (n = 138) vs. 38% (n = 1036); p < 0.001]. Other secondary end-points were also significantly in favour of early + mild treatment, including sustained pain free (SPF), SPF with no adverse events (SNAE), and time lost because of migraine (all p < 0.001). Almotriptan was well tolerated with no serious adverse events reported.

Conclusions: In the primary care setting, early intervention with almotriptan for treatment of migraine provides significant clinical benefits compared with delaying treatment and/or waiting until pain intensity has progressed beyond mild.

Trial registration: ClinicalTrials.gov NCT00725140.