Rizatriptan plus Acetaminophen as Effective as Sumatriptan plus Naproxen in Patients with Moderate to Severe Migraine

By Thomas S. May, MA

Stockholm, Sweden–Rizatriptan plus acetaminophen has comparable efficacy to that of the combination drug Trexima (sumatriptan plus naproxen) in treating moderate or severe migraine, according to a study presented here at the 13th Congress of the International Headache Society.

The authors of the study, led by Fred Freitag, DO, associate director of the Diamond Headache Clinic in Chicago, Illinois, conducted a randomized, controlled trial to evaluate the efficacy of rizatriptan (R) plus acetaminophen (A), in comparison with R or A alone, or placebo. 200 patients (87.8% female, mean age of 43.1 years) with moderate or severe migraine were randomly assigned to one of four treatment groups and were treated with 10 mg of rizatriptan (R), 1000 mg of acetaminophen (A), their combination (R+A), or placebo (P). Baseline characteristics were similar in all groups.

28 patients were excluded from the analysis because they did not treat a headache within the time specified (two months) or withdrew consent. Logistic regression analysis showed that two-hour pain relief was significantly greater among patients assigned to the R+A treatment group when compared to patients treated with P (p < 0.0001) or A alone (p = 0.023). Two-hour pain relief was defined as a change from severe or moderate pain to mild pain, or moderate pain to no pain, according to visual analog scale (VAS) scores, two hours after treatment.

There was a trend in favor of R+A vs. R alone; however, this difference did not reach statistical significance (p = 0.118). No significant differences were observed between groups regarding the number or severity of adverse events, according to the authors.

Commenting on the results, Dr. Freitag noted that the combination was statistically more effective than placebo or acetaminophen alone and numerically superior to rizatriptan by itself. “This was basically across the range of the primary and secondary outcome measures, and if we include the loss of the migraine-associated symptoms, we had a migraine-free rate comparable to Trexima,” said Dr. Freitag. “What this means is that, in patients who are less responsive to a triptan by itself, combining it with a simple, over-the-counter medication like acetaminophen can be far more effective.”

This research builds on previous work by GlaxoSmithKline that used the combination of sumatriptan and naproxen, explained Andrew Dowson, PhD, director of King's Headache Service, King's College Hospital, London, UK, who was not associated with the study. "It shows that co-administration has a synergistic effect," he said. "It's good to have data across triptans other than sumatriptan," Dr. Dowson added. "Co-administration will likely have synergy across the triptan group, but we need similar evidence to back this statement."

Home  Portfolio  Contact