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Efficacy of Sumatriptan Rapid Release Tablets in Patients Treated During Migraine Aura: Presented at IHS

By Claire Sowerbutt

KYOTO, JAPAN -- October 17, 2005 -- Treating migraine with sumatriptan rapid release tablets during the aura phase provides considerably improved clinical benefits compared with early treatment, defined as within 1 hour of onset, according to data presented during the 12^th Congress of the International Headache Society (IHS).

"It is established that treating migraine early is the most efficacious approach. We wanted to determine the earliest point at which one could treat migraine," said lead investigator Dr. Sheena K. Aurora, MD, neurologist, Swedish Medical Center, Seattle, Washington.

While 32 patients were initially recruited, 19 had established aura in 3 migraine attacks, which was a mandatory eligibility criterion. These participants treated 8 migraine headaches overall, 3 with their usual treatment, 1 5 hours following the onset of aura (late treatment), 2 within 1 hour of the onset of pain (early treatment), and 2 attacks during aura.

"In this study we used 100-mg sumatriptan rapid release tablets without placebo, to establish intrapatient consistency," Dr. Aurora said. All 19 patients completed the study.

Results show greater freedom from pain at 2 hours after administration of treatment in patients who treated their migraine during the aura phase -- 89 minutes versus 82 minutes with early treatment and 60 minutes with late treatment. Similarly, sustained freedom from pain was greater in patients who administered treatment during aura compared with early and usual treatment -- 84 minutes, 68 minutes, 61 minutes, respectively.

"Early treatment was established within 60 minutes of the onset of pain, assuming that aura lasted 60 minutes or less, so we believe the time of onset of pain is approximately 60 minutes," Dr. Aurora said.

"Most of the patients did take treatment within 113 minutes (usual treatment). When we asked them to treat with their usual treatment at the onset of aura, the mean time to treatment was 2.3 minutes, compared with 85.2 minutes for early treatment," Dr. Aurora said.

With respect to pain-free status, 60% of patients who treated at 113 minutes achieved this endpoint, and 89% became pain free who treated within a few minutes of the onset of aura.

"There was not a great deal of difference between the 2 treatment groups with respect to pain freedom. However, complete pain response, which means no phonophobia, photophobia, vomiting, nausea, or pain, occurred in 79% of patients who treated during aura, 61% of those who treated within 1 hour of the onset of pain or 2 hours within onset of aura, and only 47% of those who used usual treatment," Dr. Aurora said.

"We also calculated the recommended Michele Ferrari sustained pain freedom scores, which were 84% if they treated during aura, 68% if they treated early, and 51% in the usual treatment group, at a mean of 113 minutes," she added.

"We need to do double-blind, placebo-controlled studies. But we have established intrapatient consistency in this study. Population-based studies with patients with and without aura are flawed," Dr. Aurora concluded.


[Presentation title: Preliminary Evidence for Improved Efficacy When Patients Treat with Sumatriptan Formulated With RT Technology During Visual Aura in Migraine. Poster F038]

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