Jan Lewis Brandes, M.D., of the Nashville Neuroscience Group, Nashville, Tenn., and colleagues evaluated the effectiveness and safety of treating migraine by combining the migraine medications sumatriptan (in the class of drugs known as triptans) and naproxen sodium (a nonsteroidal anti-inflammatory drug; NSAID) compared with placebo and single therapy with either of the drugs.
The research consisted of two identical, randomized, double-blind studies conducted among 1,461 (study 1) and 1,495 (study 2) patients at 118 U.S. clinical centers who were diagnosed as having migraine and received study treatment for a moderate or severe migraine attack. Patients were randomized to receive a single tablet containing both sumatriptan, 85 mg, and naproxen sodium, 500 mg; sumatriptan, 85 mg (monotherapy); naproxen sodium, 500 mg (monotherapy); or placebo, to be used after onset of a migraine with moderate to severe pain.
The researchers found that sumatriptan–naproxen sodium was more effective than placebo for headache relief at two hours after dosing (study 1, 65 percent vs. 28 percent; and study 2, 57 percent vs. 29 percent;), absence of photophobia (sensitivity to light) at two hours (58 percent vs. 26 percent; and 50 percent vs. 32 percent;), and absence of phonophobia (sensitivity to sound) at two hours (61 percent vs. 38 percent; and 56 percent vs. 34 percent).
The absence of nausea two hours after dosing was higher with sumatriptan–naproxen sodium than placebo in study 1, but in study 2 rates of absence of nausea did not differ between sumatriptan–naproxen sodium and placebo. For 2- to 24-hour sustained pain-free response, sumatriptan–naproxen sodium was superior to sumatriptan monotherapy, naproxen sodium monotherapy and placebo. The incidence of adverse events was similar between sumatriptan–naproxen sodium and sumatriptan monotherapy.
MEDICA.de; Source: American Medical Association