By Thomas S. May
STOCKHOLM, SWEDEN -- July 1, 2007 -- The efficacy of combination treatment with rizatriptan and acetaminophen (Paracetamol) is comparable to the combination medication Trexima (sumatriptan and naproxen) in patients with moderate or severe migraine, researchers said here at the 13th Congress of the International Headache Society (IHS).
The investigators, led by Fred Freitag, DO, Associate Director, Diamond Headache Clinic in Chicago, Illinois, United States, conducted a randomised, controlled trial to evaluate the efficacy of rizatriptan (R) plus acetaminophen (A), in comparison with R or A alone, or placebo. Results of the study were presented at a poster session on Sunday, July 1, 2007.
Patients (N=200) (87.8% female; mean age 43.1 y) with moderate or severe migraine were randomly assigned to one of four treatment groups and were treated with rizatriptan 10 mg (R) or acetaminophen 1,000 mg (A), their combination (R + A), or placebo (P). Baseline characteristics were similar in all groups.
Logistic regression analysis showed that 2-hour pain relief was significantly greater in the R + A treatment group when compared with patients treated with P (P <.0001) or A alone (P =.023). There was a trend in favour of R + A versus R alone; however, this difference did not reach statistical significance (P =.118). No significant differences were observed between groups regarding the number or severity of adverse events, according to the authors.
Commenting on the study, Dr. Freitag noted that the results, which were powered to show a difference between the combination of rizatriptan 10 mg and acetaminophen 1,000 mg, were very significant. "The combination was statistically more effective than placebo or acetaminophen alone and numerically superior to rizatriptan by itself," he said.
"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."
Financial support for the study was provided by Merck Inc.
[Presentation title: Placebo Controlled Study to Evaluate the Efficacy of Rizatriptan With Acetaminophen for the Treatment of Migraine. Abstract F091]
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