Efficacy and safety of 1,000mg effervescent aspirin: individual patient data meta-analysis of three trials in migraine headache and migraine accompanying symptoms |
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Authors: | Christian Lampl M Voelker H C Diener |
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Institution: | 1.Dept. of Neurology, Pain and Headache Center,Krankenhaus der Barmherzigen Schwestern,Linz,Austria;2.Bayer HealthCare AG,Leverkusen,Germany;3.Dept. of Neurology,University of Duisburg-Essen,Essen,Germany |
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Abstract: | Migraine is often associated with health consequences including impaired quality of life, and the cost of treating migraine
headaches places a significant financial burden on patients who suffer from migraines. Nonsteroidal anti-inflammatory drugs
(NSAIDs) and triptans are commonly used for the treatment of acute migraine attacks. Aspirin is widely accepted as a treatment
option for migraine pain relief and could provide an alternative not only for treatment of moderate migraine attacks, but
also for severe migraine attacks. The efficacy and safety of 1,000 mg effervescent aspirin (eASA) was evaluated in comparison
to 50 mg sumatriptan and placebo in an individual patient data meta-analysis of three randomized, placebo-controlled, single-
dose migraine trials. Pain-relief at 2 h, pain-free at 2 h and sustained pain-free up to 24 h were calculated. For eASA, the
response rates were 51.5 % (95 % CI: 46.6–56.5 %), 27.1 % (95 % CI: 22.6–31.4 %), and 23.5 % (95 % CI: 19.3–27.7 %). For sumatriptan,
the response rates were 46.6 % (95% CI: 40.0–53.2 %), 29% (95 % CI: 23.0–34.9 %), and 22.2 % (95 % CI: 16.7–27.6 %). The corresponding
rates for placebo were 33.9 % (95% CI: 29.1–38.6 %), 15.1 % (95 % CI: 11.5–18.7 %), and 14.6 % (95 % CI: 11.0–18.1 %). The
treatment effect of eASA and sumatriptan were significantly different from placebo (p < 0.001), but differences between eASA
and sumatriptan were not significant. The remission of accompanying symptoms and the subgroup analyses of patients with moderate
or severe migraine pain at baseline revealed no significant differences between eASA and sumatriptan. Safety was evaluated
based on the frequency of reported adverse events, and treatment with eASA was associated with lower incidence of adverse
events than was with sumatriptan. This individual patient data meta-analysis provided evidence that eASA 1,000mg is as effective
as sumatriptan 50mg for the treatment of acute migraine attacks and has a better side effect profile. This is also true for
patients with moderate as well as severe headache at baseline. Patients therefore should be advised to use eASA first for
migraine attacks and use a triptan in case of no response. |
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Keywords: | migraine effervescent aspirin sumatriptan |
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