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Efficacy of oral ketoprofen in acute migraine

A double-blind randomized clinical trial

* See the Appendix on page 1664 for a list of participating investigators in the Bi-Profenid Migraine Study Group.
From the Laboratoire Aventis (Drs. Dib and Garcia–Acosta), Paris; Service de Neurologie (Drs. Massiou and Bousser), Hôpital Lariboisière, AP-HP, Paris; CHU–Service de Neurologie (Dr. Weber), Bâtiment Neurologique, Nancy; and Service de Neurologie (Dr. Henry), Hôpital Pellegrin–Tripode, Bordeaux, France.

Address correspondence and reprint requests to Dr. M.G. Bousser, Service de Neurologie, Hôpital Lariboisière, 2 rue Ambroise Paré, 75475 Paris Cedex, France; e-mail: mg.bousser{at}lrb.ap-hop-paris.fr

:Background Certain nonsteroidal anti-inflammatory drugs are effective in the acute treatment of migraine attacks. The authors report a double-blind, placebo-controlled, randomized cross-over trial of a dual-release formulation of oral ketoprofen in the acute treatment of migraine attacks.

Methods: The authors compared the efficacy of two doses of ketoprofen (75 or 150 mg) with that of placebo (primary analysis) and zolmitriptan 2.5 mg (secondary analysis) on one to four consecutive attacks in 235 intent-to-treat patients (out of 257 randomized patients) with migraine with or without aura. The principal efficacy outcome was headache relief (reduction in headache severity from severe or moderate to mild or absent at 2 hours).

Results: Results are based on 838 attacks with a severe or moderate headache that were evaluable at 2 hours. Relief was reported for 62.6% of headaches treated with ketoprofen 75 mg, 61.6% with ketoprofen 150 mg, and 66.8% with zolmitriptan. The difference between the three active treatments and placebo (27.8% relief) was highly significant, both tests of ketoprofen vs placebo being globally controlled at a 5% level for the type I error (primary analysis). Headaches at 2 hours disappeared more frequently for the active treatments than for placebo. The authors also demonstrated efficacy on most other secondary outcomes. The tolerance of ketoprofen was good (similar to that of placebo).

Conclusions: Oral ketoprofen (75 mg or 150 mg) in a dual-release formulation is an effective and well-tolerated drug in the acute treatment of migraine attacks.

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