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Conrad Notes
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R.C. Cady, MD, Headache Care Center, Springfield, Mo, described a 15-center, double-blind, well-controlled study on 132 working migraineurs. As a single 6-mg subcutaneous dose, SUMA relieved migraine attacks of 79% in this group compared with 32% treated with placebo. SUMA helped restore normal work performance within two hours in 52% vs 9% of the placebo controls. Both preparations were well-tolerated. Please consult Imitrex® Injection for prescribing information.

Enrolled study patients Each qualified patient was at least 18 years old, presented a history of one to six moderate to severe migraine attacks per month during the last 60 days, and worked a minimum shift of 8 hours. About 50% of the 132 study patients gave their occupation as administrative support or professional. As expected, 85% were female and 15% male. Nearly all of the participants (94.5%) were white.
Evaluation of test and control agents This double-blind, randomized, placebo-controlled, parallel study required the patients' migraine attack to have occurred during the first four hours of a work shift. The attack, prior to injection with SUMA or placebo, had to be moderate to severe in intensity to qualify.

Each patient treated the attack by subcutaneous injection of the randomly assigned 6-mg dose of SUMA or equal volume of placebo. Data collection by patient diary included headache relief, safety of injected solution, time missed or absent due to migraine, and effectiveness on the job.

Results with SUMA vs placebo SUMA, compared with placebo, led to significantly more patients getting headache relief and returning earlier to normal work. As seen below, placebo-treated patients also lost more productive time on the job:

  • relief at two hours was reported as complete by 52% of SUMA-treated patients compared with 11% on placebo (p<0.01)

  • meaningful relief at two hours was reported by 79% of the patients in the SUMA-medicated group and by 32% on placebo (p<0.01)

  • at two hours post-dose, 52% of the SUMA patients returned to normal work performance contrasted with 9% of the placebo patients (p<0.001)

  • productivity loss within two hours of dosing averaged 38.6 min for the SUMA group and 53.6 min for the placebo group (p<0.01)

Cady extrapolated the 2-hour data across the total work shift. This extension showed the mean productivity loss (addition of time missed due to reduced effectiveness and time missed from work) to be 85.6 minutes for the SUMA group and 167.9 minutes for the placebo group (p<0.01). By the end of the work shift, 66% of the SUMA- and 18% of the placebo-treated patients achieved normal work performance (p<0.01).

Safety of SUMA in the workplace The adverse events were similar in quality and quantity to those reported in previous studies. Warm or hot sensations, nausea, and vomiting were the most frequently experienced side effects.
Comments This well-controlled study showed that 6 mg of injected SUMA led to significant relief of migraine and reduced the loss in productivity. A follow-up study is needed to determine the afterwork persistence of migraine relief. A repeat study using the SUMA nasal spray merits undertaking.

For professional correspondence, please contact Dr. Cady at: Fax (417) 890-8827

Eugene A. Conrad

Presented at Thirty-ninth Annual Scientific Meeting, American Association for the Study of Headache (AASH), June 19-22, 1997
Copyright © 1997 Conrad Group, Inc. All Rights Reserved
Eugene A. Conrad, PhD, MPH / ISSN 1078-2230 / September 1997

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