Double–Blind, Placebo–Controlled, Crossover Study of Early–Intervention with Sumatriptan 85/Naproxen Sodium 500 in (Truly) Episodic Migraine: What's Neck Pain Got to Do with it?

Abstract

Objective: Published studies of triptans in acute migraine have shown relatively disappointing 2–hour pain–free rates, ranging from 18% to 58%, with 2– to 24–hour sustained pain–free rates from 17% to 25%. A major flaw in the design of previous studies may have contributed to disappointing results: many subjects are not truly episodic in the nature of their headaches—they discount days with mild headache and ignore days with migraine–related neck pain. Believing that neck pain is integrally related to migraine, we sought to ascertain whether early treatment with sumatriptan 85/naproxen sodium 500 (sumatriptan/naproxen) in truly episodic migraineurs is more robust than results when neck pain has not been considered. Methods: Successfully screened adult migraineurs who returned baseline diaries showing 2 to 7 migraine attacks monthly and < 15 headache and/or neck pain days/month received blister packs containing 3 sumatriptan/naproxen/1 placebo for treatment of 4 migraines. Instructions were to treat within the first 30 minutes of mild headache or neck discomfort—but only if the preceding day was completely free of both headache and neck pain. Results: In our study, 63.9% of patient attacks treated with sumatriptan/naproxen achieved 2–hour pain freedom compared with 33.3% of those with placebo (P < 0.001). Sustained pain freedom (2—24 hours) was achieved in 69.1% of sumatriptan/naproxen–treated attacks, compared with 23.3% with placebo (P < 0.01). More subjects using sumatriptan/naproxen achieved sustained pain freedom (than 2–hour pain freedom), due to 6 time points when the subject was sleeping/napping 2–hours post dose (5 sumatriptan/naproxen, 1 placebo), yet attested to no discomfort between 2 and 24 hours post dose. Had the attacks been scored as pain–free at 2 hours, the 2–hour pain–free and sustained pain–free rates with sumatriptan/naproxen would have been identical at 69.1% (vs 36.7% with placebo). With truly episodic migraineurs, pain freedom was significant as soon as 15 minutes following treatment with sumatriptan/naproxen (5.2% vs 0% with placebo; P < 0.01). Conclusion: Our study results support a fundamental re–evaluation of the role of neck pain in migraine.

Keywords:

• migraine
• neck pain
• episodic
• treatment
• pain–free response
• sumatriptan/naproxen