The study was in fact two studies designed to address six co-primary endpoints per study. "It was designed to address not only pain but also the associated symptoms of nausea, phono/photophobia that are so troublesome for so many migraineurs," said lead investigator Jan Brandes, Neurologist and Psychiatrist, Nashville Neuroscience Group, Nashville, Tennessee, United States.

The first study randomised 1736 patients, with data on 1470 patients available for the intent-to-treat (ITT) analysis. The second study randomised 1677 patients, with data from 1441 patients available for the ITT analysis.

"The trial enrolled patients who had suffered from migraine for nearly 2 decades. They were predominantly Caucasian women of approximately 40 years of age," Dr. Brandes said. The ITT population included only those participants who recorded moderate to severe pain at baseline, and provided at least one assessment of the treatment effects. Therapeutic gain was determined as the active response less the placebo effect.

"When we look at the attacks that were treated, severe pain was somewhat higher than that seen in some of the earlier sumatriptan trials. When thinking about being able to treat these attacks, and achieve a 2- to 24-hours pain-free response, this endpoint becomes all the more meaningful," Dr. Brandes said.

Results show a 16% therapeutic improvement among patients who used the combination medication in the first study, and 17% in the second study (P < .001 for both). In one study SumaRT/NAP showed significant efficacy in reducing nausea compared to either agent alone (P < .001). Among patients taking naproxen alone, 4% achieved a 2- to 24-hour sustained pain-free response in the first study, as did 8% in sumatriptan group.

"It would appear that there is something about the combination that produces a possible synergistic effect, translating into greater therapeutic gain in these patients," Dr. Brandes said.

"When we look at safety, the side effects are close to results seen in other studies," she added.

"Overall, the data for the combination show statistical difference on the outcomes of pain, photo- and phonophobia [P < .001 vs. SumaRT, naproxen and placebo] and when the trials are combined, there is statistical improvement in nausea [P < .005 vs. SumaRT, naproxen and placebo]," Dr. Brandes said.

"In the most difficult parameter -- 2- to 24-hour pain-free response -- both studies showed statistical superiority for the combination product over either of the component products alone [P < .001]," she said.


[Presentation title: Therapeutic Advances in Acute Headache Entitle: "Therapeutic Clinical Benefits of a New Single-Tablet Formulation of Sumatriptan Formulated with RT Technology and Naproxen Sodium. Oral presentation, Scientific Session 6]

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