Sumatriptan With Naproxen Offers Some Advantages for Migraine

Allison Gandey

July 07, 2010

July 7, 2010 (Los Angeles, California) — A single fixed dose of sumatriptan with naproxen offers more complete pain relief over usual triptans, a new study suggests.

Compared with triptans alone, the combination of sumatriptan with naproxen (Treximet, GlaxoSmithKline) provided more complete relief with a single dose and better pain relief, although triptans were still deemed better by patients on the speed of complete relief.

The study was funded by GlaxoSmithKline. Their results, released here at the American Headache Society 52nd Annual Scientific Meeting, used nontraditional endpoints.

The new survey assesses nontraditional endpoints.

Why new benchmarks? Lead investigator Roger Cady, MD, from the Clinvest Headache Center in Springfield, Missouri, says current endpoints for triptans have remained essentially unchanged since the 1990s. "While useful, these measures do not fully explore outcomes that are relevant to today's migraine patients," he told Medscape Medical News.

The newly developed Migraine Completeness of Response Survey is designed to assess new outcomes such as speed of relief, return to functionality, and psychological symptoms. "This is a pilot survey and will require validation," Dr. Cady said during an interview.

Investigators studied 147 patients with migraine currently using a triptan as their primary therapy. Participants were enrolled at 8 investigative sites and completed the new survey. They also completed the Revised Perception of Migraine Questionnaire — a fully validated instrument to assess satisfaction with migraine medication.

During the study, patients were treated with sumatriptan and naproxen. The drug is a 5-hydroxytryptamine 1 receptor agonist that mediates vasoconstriction of the basilar artery and vasculature. It also contains naproxen, a nonsteroidal anti-inflammatory drug.

Two months into the study, participants again answered the surveys. Investigators found the combination therapy achieved statistical significance in frequency of complete relief with a single dose (0.29 mean score difference; P = .0019) and the pain score (0.17 mean difference; P = .0157). Usual triptans fared better in speed of complete relief (−0.13 mean score difference; P = .05).

The other areas, such as return to functionality, associated symptoms, and psychological and affective symptoms, did not reach statistical significance.

Scores on all areas of the patient perception questionnaire at the end of the study increased over baseline, suggesting greater satisfaction with the study medication than with the patient's previous triptans.

Table 1. Mean Scores on Patient Perception of Migraine Questionnaire

Scale Baseline (Range) Using Triptans (n = 147) Baseline (Range) Using Sumatriptan and Naproxen (n = 138)
Efficacy 71.5 (18.2 – 100) 81.0 (0 – 100)
Functionality 45.9 (4.2 – 100) 80.5 (0 – 100)
Ease of use 50.7 (33.3 – 100) 93.7 (25 – 100)
Adverse effects 86.0 (9.5 – 100) 88.9 (32 – 100)

 

According to prescribing information for sumatriptan with naproxen, the combination therapy may cause an increased risk for serious cardiovascular thrombotic events, myocardial infarction, and stroke. This risk may increase with duration of use.

Dr. Roger Cady

Treatment has also been linked to an increased risk for serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines. According to the manufacturer and regulators, these events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

"It is important to have a wide variety of treatment options, but we need to look at specific patients and assess the risks and benefits," Dr. Cady said.

In a recent article on new acute treatments for headache, Alan Rapoport, MD, from the University of California at Los Angeles, agreed that alternatives are important (Neurol Sci. 2010;31:129-132).

"Although we have several acute care medications for the treatment of migraine, we are always looking for new medications to treat our patients," Dr. Rapoport noted. "Patients often say that their headaches are not under optimal control and would be happy to try another medication."

Patients, he added, are looking for faster relief, more complete relief, no recurrent headache, and no adverse events.

This study was funded by GlaxoSmithKline. Dr. Cady has received research funding from the company. Dr. Rapoport has received support from Merck, NuPathe, MAP, Pfizer, Endo, Forest, Pfizer, and Zogenix. He is an author of the Phase IIB study on telcagepant.

American Headache Society (AHS) 52nd Annual Scientific Meeting: Poster 99. Presented June 25, 2010.

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