For women who suffer from menstrual migraines, menstrual cramps (dysmenorrhea) and other menstrual symptoms, combination therapy with sumatriptan plus naproxen may provide rapid and sustained pain relief, the results of two controlled trials indicate.

The studies also show that sumatriptan-naproxen is well tolerated, relieves nonpainful menstrual symptoms (bloating, tiredness, irritability) and reduces the need for rescue medication.

“Sumatriptan-naproxen may be targeting pathophysiologic mechanisms inherent both to migraine and dysmenorrhea,” according to Dr. Lisa K. Mannix from Headache Associates, West Chester, Ohio and colleagues.

Sumatriptan is a migraine drug sold under the trade name Imitrex. It belongs to a drug class called selective serotonin receptor agonists and works by narrowing blood vessels in the head and stopping pain signals from being sent to the brain.

Naproxen is an over-the-counter nonsteroidal anti-inflammatory drug (NSAID) that works by stopping the body’s production of a substance that triggers pain, fever and inflammation. Naproxen is sold under the trade name Aleve, Anaprox and several others.

In the current issue of the journal Obstetrics and Gynecology, the researchers describe two studies in which women with menstrual migraine and dysmenorrhea were randomly assigned to headache treatment during the mild pain phase (within 1 hour of onset) with sumatriptan 85 milligrams and naproxen sodium 500 mg in a single-fixed dose formulation, or they were assigned to treatment with placebo. There were 311 women in study 1 and 310 in study 2.

The researchers report that sumatriptan-naproxen was statistically superior to placebo in both studies for 2-hour pain-free response (the study’s primary end point), which was maintained up to 48 hours.

With sumatriptan-naproxen, 2-hour pain-free rates were 42 percent and 52 percent in study 1 and study 2, respectively, versus 23 percent and 22 percent with placebo.

Two- to 24-hour pain-free rates with sumatriptan-naproxen were 29 percent in study 1 (versus 18 percent with placebo) and 38 percent in study 2 (versus 10 percent with placebo).

Pain-free rates with sumatriptan-naproxen through 48 hours were 26 percent and 28 percent in study 1 and 2, respectively, compared with 17 percent and 8 percent with placebo.

These data, Mannix and colleagues say, suggest that sumatriptan-naproxen provides both early and sustained pain relief in at least 25 percent of women with these two painful conditions.

No serious adverse events were noted in either study. Nausea and dizziness were the most frequently reported adverse events, both of which are commonly reported in migraine patients as well as in previous studies of sumatriptan-naproxen, the team notes.

SOURCE: Obstetrics and Gynecology, July 2009.