Ketoprofen Effective, Well-Tolerated in Acute Migraine

Laurie Barclay, MD

July 01, 2002

July 2, 2002 — Oral ketoprofen in a dual-release formulation is about as effective as zolmitriptan in controlling acute migraine, according to results of a randomized, double-blind clinical trial reported in the June issue of Neurology.

"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," write M. Dib, MD, from the Hopital Lariboisiere in Paris, and colleagues from the Bi-Profenid Migraine Study Group. "The tolerance of ketoprofen was good (similar to that of placebo)."

In this crossover design trial, the authors compared the efficacy of 75 or 150 mg of ketoprofen with that of placebo (primary analysis) and with that of zolmitriptan 2.5 mg (secondary analysis). Of 257 randomized patients with migraine with or without aura, there were 235 intent-to-treat patients with one to four consecutive attacks, or 838 attacks of severe or moderate headache evaluable at two hours.

At two hours after treatment, 62.6% of patients receiving 75 mg ketoprofen, 61.6% of patients receiving 150 mg ketoprofen, and 66.8% of patients receiving zolmitriptan had relief, compared with 27.8% of those receiving placebo ( P<.001 for active treatments compared with placebo).

Ketoprofen was also effective on most other secondary outcomes. Compared with the 150-mg dose, the 75-mg dose was less effective in abolishing the headache, and it was associated with longer headache duration after treatment and with a lower level of patient satisfaction.

"Given these results, ketoprofen can be considered, together with triptans and some other NSAIDs, as a first-line drug in the acute treatment of migraine attacks," the authors write. "Although overall drug responses appear similar in the two treatment arms, individual patients with headaches of different severity may respond optimally to one or other of the treatments."

Aventis supported this study.

Neurology. 2002; 58(11):1660-1665

Reviewed by Gary D. Vogin, MD


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