Sumatriptan and naproxen sodium for the acute treatment of migraine

Sumatriptan and naproxen sodium for the acute treatment of migraine
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DOI:
10.1111/j.1526-4610.2005.05178.x
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发表时间:
2005-09-01
期刊:
影响因子:
5
通讯作者:
Alexander, WJ
Alexander, WJ
中科院分区:
医学3区
文献类型:
--
作者:
Smith, TR;Sunshine, A;Alexander, WJ

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Objective. - To evaluate the efficacy and tolerability of treatment with a combination of sumatriptan 50 mg ( encapsulated) and naproxen sodium 500 mg administered concurrently in the acute treatment of migraine.Background. - The pathogenesis of migraine involves multiple peripheral and central neural mechanisms that individually have been successful targets for acute ( abortive) and preventive treatment. This suggests that multimechanism therapy, which acts on multiple target sites, may confer improved efficacy and symptom relief for patients with migraine.Design and Methods. - This was a multicenter, randomized, double- blind, double- dummy, placebo- controlled, four-arm study. Participants (n = 972) treated a single moderate or severe migraine attack with placebo, naproxen sodium 500 mg, sumatriptan 50 mg, or a combination of sumatriptan 50 mg and naproxen sodium 500 mg. In the latter two treatment arms, the sumatriptan tablets were encapsulated in order to achieve blinding of the study.Results. - In the sumatriptan plus naproxen sodium group, 46% of subjects achieved 24- hour pain relief response ( primary endpoint), which was significantly more effective than sumatriptan alone ( 29%), naproxen sodium alone ( 25%), or placebo ( 17%) ( P < .001). Two-hour headache response also significantly favored the sumatriptan 50 mg plus naproxen sodium 500 mg therapy ( 65%) versus sumatriptan ( 49%), naproxen sodium ( 46%), or placebo ( 27%) ( P